Intervenciones para el alivio del dolor intraoperatorio durante la ligadura posparto de las trompas uterinas mediante minilaparotomía
Resumen
Antecedentes
La ligadura de las trompas uterinas posparto mediante minilaparotomía (LTPM) es un método anticonceptivo que funciona al interrumpir la permeabilidad de las trompas de Falopio. Para el alivio del dolor intraoperatorio se utilizan varios métodos como la administración sistémica de opiáceos o la instilación intraperitoneal de lidocaína.
Objetivos
Evaluar la efectividad y los efectos adversos asociados con las intervenciones para el alivio del dolor en las pacientes sometidas a LTPM.
Métodos de búsqueda
Se buscaron los estudios elegibles publicados el 31 de julio de 2017 o antes en el registro de estudios en línea CENTRAL, MEDLINE, Embase, PsycINFO y en CINAHL. Para encontrar estudios potencialmente relevantes, se examinaron artículos de revisión y se buscaron registros de ensayos clínicos en curso, listas de citas de estudios incluidos, libros de texto clave, literatura gris y revisiones sistemáticas anteriores.
Criterios de selección
Se incluyeron los ensayos controlados aleatorios (ECA) que compararon medidas de alivio del dolor perioperatorio durante la LTPM.
Obtención y análisis de los datos
Dos autores de la revisión evaluaron de forma independiente los títulos, resúmenes y artículos de texto completo de los estudios potencialmente relevantes para su inclusión. Se extrajeron los datos de los estudios incluidos, se evaluó el riesgo de sesgo y se calcularon y compararon los resultados. Las discrepancias se resolvieron mediante discusión o consulta con un tercer autor de la revisión. Se calculó el cociente de riesgos (CR) de la varianza inversa con el intervalo de confianza (IC) del 95% para los resultados binarios y la diferencia de medias (DM) con el IC del 95% para las variables continuas.
Resultados principales
Solo se encontraron tres ECA en los que participaron en total 230 mujeres posparto. La mayoría de los análisis se basaron en números relativamente pequeños de pacientes y estudios. En general, la certeza de la evidencia con respecto a la efectividad de las intervenciones fue baja debido al riesgo de sesgo y a la imprecisión. Se encontró evidencia de muy baja certeza con respecto a la seguridad de las intervenciones debido al riesgo de sesgo y a la imprecisión. Dos estudios tuvieron riesgo incierto de sesgo de selección. Un estudio tuvo riesgo incierto de sesgo de informe y riesgo alto de otros sesgos asociados con el protocolo del estudio.
Las pacientes que recibieron una instilación intraperitoneal de lidocaína presentaron dolor intraperitoneal de menor intensidad que las que recibieron placebo (DM agrupada ‐3,34; IC del 95%: ‐4,19 a ‐2,49; tres estudios, 190 participantes, evidencia de certeza baja), o una inyección intramuscular de morfina (DM ‐4,8; IC del 95%: ‐6,43 a ‐3,17; un estudio, 40 participantes, evidencia de certeza baja). No se encontraron diferencias claras en el dolor intraperitoneal entre las pacientes que recibieron una inyección intramuscular de morfina agregada a una instilación intraperitoneal de lidocaína y las que recibieron una instilación intraperitoneal de lidocaína sola (DM ‐0,40; IC del 95%: ‐1,52 a 0,72; un estudio, 40 participantes, evidencia de certeza baja). Una inyección intramuscular de morfina sola no fue efectiva para el alivio del dolor intraperitoneal en comparación con placebo (DM 0,50; IC del 95%: ‐1,33 a 2,33; un estudio, 40 mujeres, evidencia de certeza baja). Ninguno de los estudios informó eventos adversos graves, pero la evidencia fue de certeza muy baja. La instilación intraperitoneal de lidocaína puede reducir la cantidad de pacientes que necesitaron control adicional del dolor en comparación con placebo (CR 0,27; IC del 95%: 0,17 a 0,44; tres estudios, 190 mujeres, evidencia de certeza baja).
Conclusiones de los autores
Una instilación intraperitoneal de lidocaína durante la ligadura de las trompas uterinas posparto mediante minilaparotomía antes de que las trompas de Falopio se aten puede ofrecer un mejor control del dolor intraperitoneal, aunque la evidencia con respecto a los efectos adversos es poco clara. No se encontraron diferencias claras en el dolor intraperitoneal entre las pacientes que recibieron una combinación de inyección de morfina e instilación intraperitoneal de lidocaína y las que recibieron una instilación intraperitoneal de lidocaína sola. Estos resultados se deben interpretar con precaución porque la evidencia en general fue de certeza muy baja.
PICO
Resumen en términos sencillos
Intervenciones para el alivio del dolor intraoperatorio durante la ligadura posparto de las trompas uterinas mediante minilaparotomía
Pregunta de la revisión
El objetivo de esta revisión fue comparar las intervenciones para el alivio del dolor intraoperatorio con otras intervenciones o ninguna intervención, durante la ligadura de las trompas uterinas (atado de las trompas uterinas) mediante minilaparotomía (incisión quirúrgica pequeña a través de la pared abdominal) después del parto.
Antecedentes
La ligadura de las trompas uterinas es una forma permanente de regulación de la natalidad durante la cual las trompas uterinas de una mujer se cortan o se bloquean quirúrgicamente para prevenir el embarazo. Esta cirugía se puede realizar mediante una minilaparotomía. Para el alivio del dolor durante la ligadura de las trompas uterinas mediante minilaparotomía se utilizan diversos métodos. Algunos métodos de alivio del dolor incluyen una inyección de fármacos antiinflamatorios no esteroideos (una clase de medicamentos que puede aliviar el dolor y la fiebre), los opiáceos (una clase de medicamentos relacionados en cuanto a estructura con el opio), o verter lidocaína (un medicamento utilizado para adormecer el tejido de un área específica) en la cavidad abdominal.
Características de los estudios
Se incluyeron tres ensayos controlados aleatorios con un total de 230 mujeres. Estos estudios compararon la lidocaína vertida en la cavidad abdominal con placebo u otros tratamientos como una inyección de morfina (también conocida como un opiáceo) en el músculo, o la combinación de lidocaína y morfina. Todos los estudios tuvieron lugar en Tailandia. La evidencia aquí descrita proviene de estudios publicados antes del 31 de julio de 2017.
Resultados clave
Verter lidocaína en la cavidad abdominal durante la ligadura de las trompas uterinas mediante minilaparotomía antes de que las trompas de Falopio se aten después del parto puede ofrecer un mejor control del dolor que un placebo o la inyección de morfina, aunque la evidencia con respecto a los efectos adversos es poco clara. Las pacientes que recibieron una combinación de inyección de morfina y lidocaína vertida en la cavidad abdominal no mostraron diferencias claras en el dolor comparadas con las que recibieron lidocaína sola. Una inyección de morfina sola en el músculo no alivió el dolor más que un placebo.
Certeza de la evidencia
La certeza de la evidencia con respecto a la efectividad de estas intervenciones fue baja debido al riesgo de sesgo y a la imprecisión de los resultados. La certeza de la evidencia con respecto a la seguridad de las intervenciones fue muy baja debido al riesgo de sesgo y a la imprecisión.
Conclusiones de los autores
Summary of findings
| EMLA cream compared to placebo cream for pain during abdominal entry | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia Settings: inpatient settings; tertiary hospitals Intervention: EMLA cream Comparison: placebo cream | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of women | Certainty of the evidence | Comments | |
| Risk with placebo | Risk with EMLA cream | |||||
| Pain during abdominal entry (NRS; higher = more pain) | The mean pain score with placebo cream during abdominal entry was 4.6 | The mean pain score with EMLA cream was 3.18 lower (4.10 lower to 2.26 lower) | ‐ | 90 | ⊕⊕⊝⊝ | MD ‐3.18, 95% CI ‐4.10 to ‐2.26 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 90 | ⊕⊝⊝⊝ | No reported adverse events occurred for this comparison |
| Number of women requiring rescue medication | 1000 per 1000 | 360 per 1000 (250 to 530) | RR 0.36 (0.25 to 0.53) | 90 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). NRS: numeric rating scale; CI: confidence interval; RR: risk ratio; MD: mean difference | ||||||
| GRADEs (certainty) of the evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine instillation compared to placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with placebo instillation (normal saline) | Risk with lidocaine instillation | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score in the lidocaine was 3.34 lower | ‐ | 190 | ⊕⊕⊝⊝ | MD ‐3.34, 95% CI ‐4.19 to ‐2.49 |
| Adverse events within 48 hours post operation | 100 per 1000 | 104 per 1000 | RR 1.04 | 150 | ⊕⊝⊝⊝ | |
| Number of women requiring rescue medication | 543 per 1000 | 147 per 1000 | RR 0.27 | 190 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for other potential risk of bias, as one study did have not a well‐defined protocol for assessing adverse events, which might have impacted the reliability of reported results. 3 Downgraded two levels for very serious imprecision (due to wide confidence intervals including benefit and harm, and sparseness of reported events) | ||||||
| Intramuscular (IM) morphine compared to IM placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM placebo | Risk with IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score with IM morphine was 0.5 higher | ‐ | 40 | ⊕⊕⊝⊝ | MD 0.50, 95% CI ‐1.33 to 2.33 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were 2 cases of vomiting in the IM morphine group, and no adverse events in the placebo group. |
| Number of women requiring rescue medication | 900 per 1000 | 900 per 1000 | RR 1.00 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Intraperitoneal lidocaine instillation compared to intramuscular (IM) morphine for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM morphine | Risk with lidocaine instillation | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the morphine group was 6.0 | The mean intraperitoneal pain score in the lidocaine group was 4.8 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐4.80, 95% CI ‐6.43 to ‐3.17 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were 2 cases of vomiting in the IM morphine group, and no adverse events in the placebo group. |
| Number of women requiring rescue medication | 900 per 1000 | 198 per 1000 | RR 0.22 (0.09 to 0.54) | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Intraperitoneal lidocaine instillation plus intramuscular (IM) morphine administration compared to placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with placebo | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score in the lidocaine and morphine group was 4.7 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐4.70, 95% CI ‐6.09 to ‐3.31 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | No adverse events occurred for this comparison |
| Number of women requiring rescue medication | 900 per 1000 | 99 per 1000 | RR 0.11 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine intraperitoneal instillation plus intramuscular (IM) morphine compared to lidocaine intraperitoneal instillation alone for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with lidocaine instillation alone | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the lidocaine alone group was 1.2 | The mean intraperitoneal pain score in the lidocaine plus morphine group was 0.4 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐0.40, 95% CI ‐1.52 to 0.72 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | No adverse events occurred for this comparison |
| Number of women requiring rescue medication | 200 per 1000 | 100 per 1000 | RR 0.50 | 40 | ⊕⊝⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine intraperitoneal instillation plus intramuscular (IM) morphine compared to IM morphine alone for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing postpartum mini‐laparotomy tubal ligation (PPTL) under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM morphine alone | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the IM morphine alone group was 6.0 | The mean intraperitoneal pain score in the lidocaine plus morphine group was 5.2 lower (6.63 lower to 3.77 lower) | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐5.20, 95% CI ‐6.63 to ‐3.77 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were only two cases of vomiting in the IM morphine group, and no adverse events in the lidocaine plus morphine group |
| Number of women requiring rescue medication | 900 per 1000 | 99 per 1000 | RR 0.11 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
Antecedentes
Descripción de la afección
La ligadura de las trompas uterinas posparto mediante minilaparotomía (LTPM) es la anticoncepción permanente más frecuente en todo el mundo; el 18,9% de las pacientes eligen la esterilización como forma de anticoncepción (UN 2013). Sin embargo, el temor al dolor durante este procedimiento es una barrera importante para las pacientes que se someten a esta operación. Un estudio encontró que la puntuación media de dolor intraoperatorio en una escala de calificación numérica (ECN) para la LTPM fue 5,5 e informó que algunas mujeres (3,75%) necesitaron alivio adicional del dolor o finalmente recibieron anestesia general (Visalyaputra 1999). Por lo general el dolor ocurre durante los siguientes tres pasos: la incisión en la piel, el estiramiento del peritoneo y la ligadura de las trompas de Falopio.
Descripción de la intervención
Existen muchas técnicas para el alivio del dolor intraoperatorio durante la LTPM, que incluyen la anestesia general, regional y local. La anestesia general y regional es muy efectiva para el control del dolor durante la LTPM (Aaronson 2014). Sin embargo, estas intervenciones requieren de instituciones y anestesiólogos que podrían no estar ampliamente disponibles, en particular en los países con menos desarrollo económico. Otras intervenciones posibles incluyen una inyección de agentes anestésicos en el mesosálpinx (Benhamou 1994) o el peritoneo (Ratanalappaiboon 2012), la administración oral de fármacos antiinflamatorios no esteroideos (AINE; Putland 1999), la analgesia y la administración parenteral de opiáceos (Visalyaputra 1999). Estas intervenciones se pueden realizar con mayor facilidad y no requieren de un anestesiólogo. Por lo tanto, podrían ser más apropiadas y prácticas para los contextos de bajos recursos, si es posible evaluar su seguridad.
De qué manera podría funcionar la intervención
La administración local de lidocaína antes de la incisión solo es adecuada para el alivio del dolor asociado con la incisión en la piel. No es adecuado para el alivio del dolor durante el estiramiento del peritoneo o la ligadura de las trompas uterinas (Visalyaputra 2002). Una inyección de agentes anestésicos (p.ej. lidocaína o marcaína) en el mesosálpinx o el peritoneo puede inhibir el dolor al bloquear los canales de sodio activados por voltaje en la membrana de las células neuronales responsables de la propagación de la señal, lo que causa que no se transmita el potencial de acción (Tetzlaff 2000). La inyección intravenosa o intramuscular de AINE puede inhibir las enzimas clicooxigenasa‐1 (Cox‐1) y Cox 2 que participan en la síntesis de prostaglandinas, lo que da lugar a sus efectos analgésicos (Day 2013). La administración de opiáceos puede controlar el dolor al actuar como agonistas y agonistas‐antagonistas de los receptores µ (mu) (Trescot 2008). Estas intervenciones pueden prevenir el dolor durante el estiramiento del peritoneo y la ligadura de las trompas uterinas.
Por qué es importante realizar esta revisión
Las intervenciones mencionadas con anterioridad se han utilizado ampliamente en contextos de recursos bajos debido a su simplicidad y porque se pueden utilizar de manera ambulatoria (Chi 1992). El tratamiento adecuado del dolor mediante técnicas anestésicas locales podría hacer que la LTPM esté disponible para más mujeres que desean la esterilización, en particular en contextos de bajos recursos. Sin embargo, hasta donde se conoce no se han realizado revisiones sistemáticas que determinen la efectividad y los eventos adversos asociados con las intervenciones para el alivio del dolor intraoperatorio durante la LTPM.
Consultar el Apéndice 1 para obtener una lista de abreviaturas y el Apéndice 2 para el glosario de términos.
Objetivos
Evaluar la efectividad y los efectos adversos asociados con las intervenciones para el alivio del dolor en las pacientes sometidas a ligadura de las trompas uterinas posparto mediante minilaparotomía (LTPM).
Métodos
Criterios de inclusión de estudios para esta revisión
Tipos de estudios
Se incluyeron todos los ensayos controlados aleatorios (ECA) que compararon una intervención con otra, con placebo o con ningún tratamiento.
Tipos de participantes
Pacientes sometidas a LTPM bajo anestesia local.
Tipos de intervenciones
Se consideraron todas las intervenciones para el alivio del dolor intraoperatorio durante la LTPM. Se incluyó la inyección de lidocaína en el mesosálpinx, la instilación intraperitoneal de lidocaína, la administración oral de fármacos antiinflamatorios no esteroideos (AINE) y la inyección intramuscular (IM) de morfina.
Tipos de medida de resultado
Resultados primarios
-
Dolor durante la LTPM, determinado a través de medidas de calificación validadas como una escala de calificación numérica (ECN), una escala analógica visual (EAV), o la Faces Pain Scale‐Revised (FPSR).
Resultados secundarios
-
Efectos adversos como náuseas, vómitos, retención urinaria o adormecimiento perioral.
-
Necesidad de medicación adicional, anestesia regional o anestesia general para completar el procedimiento de LTPM.
Todos los resultados para todas las comparaciones de las medidas de alivio del dolor intraperitoneal se presentaron en las tablas "Resumen de los hallazgos".
Métodos de búsqueda para la identificación de los estudios
Búsquedas electrónicas
We searched the following computerized databases:
-
CENTRAL Register of Studies Online (CRSO) web platform (searched 31 July 2017 (Appendix 3));
-
MEDLINE Ovid (1946 to 31 July 2017 (Appendix 4));
-
Embase Ovid (1980 to 31 July 2017 (Appendix 5));
-
PsycINFO Ovid (1806 to 31 July 2017 (Appendix 6));
-
CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1961 to 31 July 2017 (Appendix 7)).
We also searched for ongoing clinical trials through ClinicalTrials.gov (www.clinicaltrials.gov) and the International Clinical Trials Registry Platform (ICTRP (www.who.int/ictrp/en/)). The former search strategy is detailed in Appendix 8.
An updated search was performed on 31 October 2018 which resulted in no new studies for inclusion.
Búsqueda de otros recursos
Unpublished and grey literature
We searched electronic databases, including Greynet.org (www.greynet.org), WorldCat Dissertations and Theses (www.worldcat.org/title/worldcat‐dissertations‐and‐theses/oclc), and Index to Theses (ProQuest Dissertations & Theses: UK & Ireland), to identify relevant conference abstracts and proceedings.
Handsearch
We searched previous systematic reviews and checked the citation lists of the included studies and key textbooks for potentially relevant references. We searched for papers in all languages and had them translated, if necessary.
Obtención y análisis de los datos
Selección de los estudios
Two review authors, Yuthapong Werawatakul (YW) and Jen Sothornwit (JS), independently assessed the titles and abstracts from our literature search. We excluded the studies that clearly did not meet inclusion criteria and evaluated the full‐texts of all possibly relevant articles to determine eligibility. Discrepancies were resolved by discussion, or by consulting a third review author (CK or PL).
Extracción y manejo de los datos
Before examining the identified trials for possible inclusion, we developed and field tested a data collection form, as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Two review authors, YW and JS, independently collected the data on the extraction forms and extracted the data under unblinded conditions. They resolved discrepancies by discussion, or by consulting a third review author, PL or Malinee Laopaiboon (ML). When necessary, we contacted the authors of the included studies to seek additional information. Correct entry of the data was verified by a third review author (PL or ML). As YW was the author of one of the included studies, JS and PL were responsible for assessing risk of bias and extracting data from this study (Ratanalappaiboon 2012).
We extracted the following data from the included studies:
-
Author, year of publication and journal citation (including language)
-
Country
-
Setting
-
Inclusion and exclusion criteria
-
Study methodology
-
Study population and disease characteristics, including total number of participant enrolled, participant characteristics, age, comorbidity, and other baseline characteristics
-
Intervention details, including type, dosage, and pattern of administration
-
Comparison(s): placebo or other treatment
-
Risk of bias (see below)
-
Duration of follow‐up
-
Outcomes: for each outcome, we extracted the outcome definition and unit of measurement; for adjusted estimates, we planned to record the variables adjusted for in the analyses
-
Results: we extracted the number of women assigned to each comparison group, the total number analysed for each outcome, and the missing women
-
Notes: funding and notable conflicts of interest of authors
Evaluación del riesgo de sesgo de los estudios incluidos
Two review authors, YW and JS, independently assessed risk of bias for each included study, based on the guidance given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved any disagreements by discussion, or by consulting PL and ML. Specifically, we assessed the risk of bias in included studies for the following domains.
1) Random sequence generation (checking for possible selection bias)
For each included study, we described the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups. We assessed the method as:
-
low risk of bias (any truly random process, e.g. random number table, computer random number generator);
-
high risk of bias (any non‐random process, e.g. odd or even date of birth, hospital or clinic record number);
-
unclear risk of bias.
2) Allocation concealment (checking for possible selection bias)
For each included study, we described the method used to conceal allocation to interventions prior to assignment, and assessed whether intervention allocation could have been foreseen in advance of, or during recruitment, or changed after assignment.
We assessed the methods as:
-
low risk of bias (e.g. telephone or central randomisation, consecutively numbered sealed opaque envelopes);
-
high risk of bias (open random allocation, unsealed or non‐opaque envelopes, alternation, date of birth);
-
unclear risk of bias.
3.1) Blinding of participants and personnel (checking for possible performance bias)
For each included study, we described the methods used, if any, to blind study participants and personnel from knowledge of which intervention a participant received. We considered that studies were at low risk of bias if they were blinded, or if we judged that the lack of blinding would be unlikely to affect results.
We assessed blinding separately for participants and personnel as:
-
low, high, or unclear risk of bias for participants;
-
low, high, or unclear risk of bias for personnel.
3.2) Blinding of outcome assessment (checking for possible detection bias)
For each included study, we described the methods used, if any, to blind outcome assessors from knowledge of which intervention a participant received. We assessed blinding separately for different outcomes or classes of outcomes.
We assessed methods used to blind outcome assessment as:
-
low, high, or unclear risk of bias
4) Incomplete outcome data (checking for attrition bias)
For each included study, we described the completeness of data including attrition and exclusion from the studies. We assessed whether attrition and exclusion were reported and the numbers included in the analysis at each stage, reasons for attrition or exclusion where reported, and whether missing data were balanced across the groups.
We assessed methods as:
-
low risk of bias (e.g. no missing outcome data; missing outcome data balanced across groups);
-
high risk of bias (e.g. numbers or reasons for missing data imbalanced across groups);
-
unclear risk of bias.
5) Selective reporting (checking for reporting bias)
For each included study, we described how we investigated the possibility of selective outcome reporting bias and what we found. We assessed the methods as:
-
low risk of bias (where it was clear that all of the study’s prespecified outcomes and all expected outcomes of interest to the review were reported);
-
high risk of bias (where not all of the study’s prespecified outcomes were reported, one or more reported primary outcomes were not prespecified, outcomes of interest were reported incompletely and so could be used, study failed to include results of a key outcome that would have been expected to have been reported);
-
unclear risk of bias.
6) Other bias (checking for bias due to problems not covered by 1) to 5) above)
For each included study, we described any important concerns we had about other possible sources of bias. We assessed whether each study was free of other problems that could put it at risk of bias:
-
low risk of other bias;
-
high risk of other bias;
-
unclear whether there was risk of other bias.
Overall risk of bias
We made explicit judgements about whether trials were at high risk of bias, according to the criteria given in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We considered an included trial to be at low risk of bias if the study was assessed to be at low risk of bias for all domains. Trials with uncertain risk of bias or with high risk of bias in one or more domains were considered to have a high risk of bias.
Medidas del efecto del tratamiento
For dichotomous data, such as nausea and vomiting, we presented results as summary risk ratios (RR) with 95% confidence intervals (Higgins 2011). For continuous data, we used the mean difference if outcomes were measured in the same way between trials. We had intended to use the standardized mean difference (SMD) to combine trials that measured the same outcome but use different methods (Higgins 2011). However, we did not calculate the SMD in the analyses, as all included studies used the same method for evaluating pain.
Cuestiones relativas a la unidad de análisis
The unit of analysis was the woman who was randomised. Cluster‐randomised and cross‐over trials were not appropriate study designs for the interventions that this review aimed to evaluate, and therefore, were ineligible for this review. We included multi‐armed trials in the analyses along with individually‐randomised trials. We included the relevant intervention groups in a pair‐wise comparison of intervention groups that met the criteria for including studies in the review. We combined groups to create a single pair‐wise comparison, using the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).
Manejo de los datos faltantes
We planned to note the levels of attrition in the included studies, and to explore the impact of including studies with high levels of missing data (more than 20% of participants were lost to follow‐up) on the overall assessment of treatment effect, using a sensitivity analysis. However, we did not perform this sensitivity analysis as none of the included studies had missing data. If feasible in future updates, we will perform a sensitivity analysis to assess the impact of a high level of missing data on the pooled results.
For all outcomes, we carried out analyses, as far as possible, on an intention‐to‐treat basis. This means we attempted to include all randomised women in the analyses, and to analyse all women in the group to which they were allocated, regardless of whether they received the allocated intervention. The denominator for each outcome in each trial was the number randomised minus any women whose outcomes were known to be missing.
Evaluación de la heterogeneidad
We planned to assess statistical heterogeneity in each meta‐analysis using the Tau², I², and Chi² statistics (Higgins 2011). We intended to regard heterogeneity as substantial if I² was greater than 30%, and either Tau² was greater than zero, or there was a low P value (less than 0.10) in Chi² test for heterogeneity (Higgins 2011).
Evaluación de los sesgos de notificación
As only three RCTs met the review inclusion criteria, we were unable to construct funnel plots to determine the possibility of publication bias (see Differences between protocol and review).
Síntesis de los datos
We carried out statistical analysis using Review Manager 5 software (Review Manager 2014). We used fixed‐effect meta‐analysis to combine data where it was reasonable to assume that studies were estimating the same underlying treatment effect (i.e. where trials were examining the same intervention, and the trials’ populations and methods were judged sufficiently similar). If there was clinical heterogeneity sufficient to expect that the underlying treatment effects differed between trials, or if substantial statistical heterogeneity was detected, we used random‐effects meta‐analysis to produce an overall summary, as long as an average treatment effect across trials was considered clinically meaningful. The random‐effects summary was treated as the average range of possible treatment effects, and we discussed the clinical implications of treatment effects differing between trials. If the average treatment effect was not clinically meaningful, we had intended to not combine trials. Had we used random‐effects analyses, we would have presented the results as the pooled treatment effect with 95% confidence intervals, and the estimates of Tau² and I² (DerSimonian 1986).
’Summary of findings’ table and assessing the certainty of evidence
We prepared 'Summary of findings' tables to display the results of the meta‐analyses, based on the methods described in Chapter 11 of the Cochrane Handbook for Systematic Reviews ofInterventions (Schünemann 2011).
We presented the results of the meta‐analyses and overall certainty of the evidence obtained from all comparisons regarding intraperitoneal pain relief measures for all outcomes of interest (pain relief, adverse effects, additional medication required), according to the GRADE approach.
We created a 'Summary of findings’ table using GRADEpro GDT (GRADEpro GDT 2015). We downgraded the evidence from high certainty by one level for each serious limitation, or by two levels for any very serious limitation, for study limitations, indirectness of the evidence, inconsistency of results, imprecision of results, and probability of publication bias. We interpreted the GRADE levels of evidence as:
-
High certainty: the true effect lies close to that of the estimate of the effect.
-
Moderate certainty: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
-
Low certainty: the true effect may be substantially different from the estimate of the effect.
-
Very low certainty: the true effect is likely to be substantially different from the estimate of effect.
Análisis de subgrupos e investigación de la heterogeneidad
We performed no subgroup analysis, as only three RCTs, assessing 230 women, met our inclusion criteria. However, we considered the type of intervention and volume of anaesthetic agent in the interpretation of findings. In future updates, we will perform subgroup analysis according to these factors, if feasible.
Análisis de sensibilidad
We performed no sensitivity analysis, as only three trials met our inclusion criteria. In future updates, if we detect statistical heterogeneity, and there is a sufficient number of included studies, we will conduct a sensitivity analysis for primary outcomes to determine the possible contribution of other clinical or methodological differences across the included studies (i.e. high or unclear risk of bias for allocation concealment or publication status).
Results
Description of studies
Results of the search
We identified 856 records from the combined searches. After removing 117 duplicate records, we screened the titles and abstracts of 739 records, and discarded 727 records, as they did not meet the inclusion criteria. We obtained the full text of 12 articles for in‐depth review, and excluded nine, leaving three randomised controlled trials (RCT) with 230 women to be included in this review. We checked the reference lists of included studies, key textbooks, and previous systematic reviews for potentially relevant references, but found no further relevant studies. We did not find any ongoing studies. See the PRISMA flow diagram in Figure 1.
Study flow diagram
Included studies
Full details of included studies are provided in the 'Characteristics of included studies' section.
Study design and setting
We included three RCTs; all were double‐blinded placebo‐controlled studies. Two RCTs were conducted in the same tertiary hospital in Bangkok, Thailand (Visalyaputra 1999; Visalyaputra 2002). The third RCT took place in a university hospital in northeast Thailand (Ratanalappaiboon 2012).
Participants
All three RCTs recruited healthy women who agreed to undergo PPTL. Exclusion criteria were history of pelvic inflammatory disease, asthma, liver disease, allergy to lidocaine, or obesity (body mass index > 32 kg/m²).
Sample sizes
The sample sizes of the RCTs ranged from 60 to 90 women.
Outcomes and interventions
Pain during PPTL
The included studies reported two time points of pain assessment during PPTL: pain during abdominal wall entry and intraperitoneal pain. Pain was assessed using the numeric rating scale (NRS), which ranged from 0 to 10 in all included studies, with higher scores indicating more pain.
Pain during abdominal entry
One study evaluated the efficacy of applying EMLA cream (eutectic mixture of lidocaine and prilocaine creams) compared to a placebo cream before the incision was made, for alleviating pain (Visalyaputra 2002). Two hours after applying the cream, forceps were used to assess pain, before making the skin incision, measured with the NRS. If the NRS score was ≥ 3, women received 10 ml of 1% lidocaine, infiltrated into the skin and subcutaneous tissue.
Intraperitoneal pain
Interventions were performed immediately after entry into the intraperitoneal cavity and before manipulation of the fallopian tubes.
Ratanalappaiboon 2012 assessed intraperitoneal pain in a total of 60 women. The study measured pain between three groups of women, one minute after the instillation into the peritoneal cavity (intraperitoneal), of 100 mg of lidocaine, 200 mg of lidocaine, or normal saline (as a placebo).
Visalyaputra 1999 assessed a total of 80 women. The study evaluated intraperitoneal pain between four study arms: (1) a placebo group, given an intramuscular injection and an intraperitoneal instillation of normal saline, (2) a morphine group, which received an intramuscular injection of 10 mg of morphine with an intraperitoneal instillation of normal saline, (3) a lidocaine group, given an intramuscular injection of normal saline and an intraperitoneal instillation of 80 mL of 0.5% lidocaine, and (4) a morphine and lidocaine group, which received either an intramuscular injection of 10 mg of morphine, or an intraperitoneal instillation of 80 mL of 0.5% lidocaine. Intraperitoneal pain was assessed three minutes after instillation.
Visalyaputra 2002 assessed a total of 90 women, comparing three groups of women who received either 1% or 2% lidocaine for intraperitoneal instillation, or normal saline as a placebo. Intraperitoneal pain was assessed one minute after instillation.
Adverse effects
All three studies reported adverse effects. Visalyaputra 1999 and Visalyaputra 2002 stated their protocol for monitoring the potential adverse effects throughout the operation. Ratanalappaiboon 2012 had no a well‐defined protocol for assessing perioperative adverse effects.
Requirement for additional medication, regional or general anaesthesia for completing PPTL procedure
In all studies, women received regional or general anaesthesia if the pain was not adequately controlled after additional medication was administered. Table 1 shows the number of women who required regional or general anaesthesia for pain control during PPTL.
| Comparision I Lidocaine instillation versus placebo | Lidocaine group (N = 120) | Placebo group (N = 70) |
| Required regional or general anaesthesia | 1 (0.83) | 22 (31.43) |
| Comparison II An intramuscular injection of morphine versus placebo | Morphine group (N = 20) | Placebo group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 2 (10.0) |
| Comparison III Intraperitoneal instillation of lidocaine with IM morphine | Lidocaine group (N = 20) | Morphine group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 4 (20.0) |
| Comparison IV Intraperitoneal instillation of lidocaine combined with an injection of morphine versus placebo | Lidocaine plus morphine group (N = 20) | Placebo group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 2 (10.0) |
| Comparison V Intraperitoneal instillation of lidocaine combined with an injection of morphine versus intraperitoneal instillation of lidocaine alone | Lidocaine plus morphine group (N = 20) | Lidocaine alone group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 1 (5.0) |
| Comparison VI Intraperitoneal instillation of lidocaine combined with an injection of morphine versus an injection of morphine alone | Lidocaine plus morphine group (N = 20) | Morphine alone group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 0 (0) |
Data are present as number of women (percentage)
Excluded studies
We excluded nine studies for the reasons described in the ‘Characteristics of excluded studies’ section. The common reasons were that the intervention used in the study was regional anaesthesia, or that postoperative pain was the outcome measure and not intra‐operative pain.
Risk of bias in included studies
See Figure 2 and Figure 3 for full details regarding risk of bias assessment in the included studies.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Allocation
Ratanalappaiboon 2012 reported that the researchers randomly assigned women to the groups using sealed opaque envelopes, which contained a computer‐generated random number. We therefore judged this study to be at low risk of selection bias (Ratanalappaiboon 2017 [pers comm]). There was no statement regarding the method used to generate and conceal the allocation sequences in Visalyaputra 1999 and Visalyaputra 2002. Therefore, we rated Visalyaputra 1999 and Visalyaputra 2002 as having an unclear risk of selection bias.
Blinding
Two studies blinded either women or outcome assessors, which led us to judge them as being at low risk of bias in this domain (Visalyaputra 1999; Visalyaputra 2002). There was no detailed description regarding the blinding of women and personnel in Ratanalappaiboon 2012.
Additional information provided by the first author of Ratanalappaiboon 2012 confirmed that this study minimized performance bias and detection bias by blinding the women and the outcome assessor (Ratanalappaiboon 2017 [pers comm]). Therefore, we also judged this study as having low risk of bias in this domain.
Incomplete outcome data
We judged all three studies as having low risk of attrition bias because all outcomes were completely measured during operation.
Selective reporting
There was little information regarding adverse effects in Ratanalappaiboon 2012, so we judged this study as having unclear risk of bias for this domain. We judged the remaining two included studies as having low risk of selective reporting bias because all expected outcomes described in the methods were reported in the results.
Other potential sources of bias
Ratanalappaiboon 2012 contained no well‐defined protocol for assessing perioperative adverse effects, so we judged this study as high risk of bias in this domain. We identified no other potential sources of bias in Visalyaputra 1999 or Visalyaputra 2002. Therefore, we determined that these two studies were at low risk of bias in this domain.
Effects of interventions
See: Summary of findings for the main comparison EMLA cream compared to placebo for pain during abdominal entry; Summary of findings 2 Lidocaine instillation compared to placebo for intra‐operative intraperitoneal pain relief; Summary of findings 3 Intramuscular morphine compared to placebo for intra‐operative intraperitoneal pain relief; Summary of findings 4 Intraperitoneal lidocaine instillation compared to intramuscular morphine for intra‐operative intraperitoneal pain relief; Summary of findings 5 Combination of intraperitoneal lidocaine instillation and intramuscular morphine administration compared to placebo for intra‐operative intraperitoneal pain relief; Summary of findings 6 Combination of lidocaine intraperitoneal instillation plus intramuscular morphine compared to lidocaine intraperitoneal instillation alone for intra‐operative intraperitoneal pain relief; Summary of findings 7 Combination of lidocaine intraperitoneal instillation plus intramuscular morphine compared to intramuscular morphine alone for intra‐operative intraperitoneal pain relief
1. Any intervention versus no intervention or placebo
1.1 EMLA cream versus placebo
Primary outcome
Pain during abdominal entry
Pain during abdominal entry was reported in only one study. Visalyaputra 2002 evaluated the effectiveness of EMLA cream in alleviating pain during the skin incision. Women received either EMLA cream or a placebo. There was less pain reported during the forceps check when EMLA cream was used, then when they used a placebo (mean difference (MD) ‐3.18, 95% confidence interval (CI) ‐4.10 to ‐2.26; 1 RCT, 90 women; Analysis 1.1).
Secondary outcomes
Adverse effects
No adverse effects were reported for these two comparison groups.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
Fewer women required additional lidocaine infiltration in the EMLA group then in the placebo group (risk ratio (RR) 0.36, 95% CI 0.25 to 0.53; 1 RCT, 90 women; Analysis 1.2).
1.2 lidocaine instillation versus placebo (normal saline)
A total of 190 women were randomised to receive various doses of lidocaine for intraperitoneal instillation versus normal saline (Ratanalappaiboon 2012; Visalyaputra 1999; Visalyaputra 2002).
Primary outcome
Intraperitoneal pain
Women who received lidocaine, regardless of the concentration, reported less intraperitoneal pain intensity then those who received normal saline (MD ‐3.34, 95% CI ‐4.19 to ‐2.49; 3 RCTs, 190 women; Analysis 2.1).
Secondary outcomes
Adverse effects
Two studies reported adverse effects, including dizziness and vomiting from the lidocaine instillation (Ratanalappaiboon 2012; Visalyaputra 2002). However, the pooled analysis showed no clear difference in the risk of adverse effects between the comparison groups (RR 1.04, 95% CI 0.40 to 2.69; 2 RCTs, 150 women; Analysis 2.2 ).
Requirement for additional medication, regional anaesthesia, or general anaesthesia
Pooled analysis indicated that there were fewer women who requiring additional pain relief measures when lidocaine was used for intraperitoneal instillation compared to placebo (RR 0.27, 95% CI 0.17 to 0.44; 3 RCTs, 190 women; Analysis 2.3).
1.3 IM morphine versus placebo (normal saline)
Visalyaputra 1999 evaluated the efficacy of an intramuscular (IM) injection of 10 mg of morphine compared to normal saline, given as a placebo, in 40 women.
Primary outcome
Intraperitoneal pain
There was no clear difference between the groups in their reports of intraperitoneal pain (MD 0.50, 95% CI ‐1.33 to 2.33; 1 RCT, 40 women; Analysis 3.1).
Secondary outcomes
Adverse effects
Two women who received IM morphine complained of vomiting; none of the women in the placebo group reported any adverse effects.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
There was no clear difference between the groups in the rate of women who required additional medication, regional anaesthesia, or general anaesthesia (RR 1.00, 95% CI 0.81 to 1.23, 1 RCT, 40 women; Analysis 3.2).
2. Intervention versus intervention
Visalyaputra 1999, compared an intraperitoneal instillation of 0.5% lidocaine with 10 mg IM morphine in 40 women.
Primary outcome
Intraperitoneal pain
Women who received an intraperitoneal instillation of lidocaine experienced significantly less pain intensity than those who received IM morphine (MD ‐4.80, 95% CI ‐6.43 to ‐3.17; 1 RCTs, 40 women; Analysis 4.1).
Secondary outcomes
Adverse effects
Two women who received IM morphine complained of vomiting; none of the women who received an intraperitoneal instillation of lidocaine reported any adverse effects.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
Significantly fewer women who received an intraperitoneal instillation of lidocaine required additional pain control measures compared to those who received IM morphine (RR 0.22, 95% CI 0.09 to 0.54; 1 RCT, 40 women; Analysis 4.2).
3. Combination of interventions versus no intervention or placebo
Visalyaputra 1999 compared a combination of an intraperitoneal instillation of 0.5% lidocaine instillation plus 10 mg IM morphine with a placebo of normal saline in 40 women.
Primary outcome
Intraperitoneal pain
Women who were given a combination of IM morphine and intraperitoneal lidocaine instillation reported significantly less pain than those who were given a placebo (MD ‐4.70, 95% CI ‐6.09 to ‐3.31; 1 RCT, 40 women; Analysis 5.1).
Secondary outcomes
Adverse effects
There were no adverse events observed in this comparison.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
Significantly fewer women who were given a combination of IM morphine and intraperitoneal lidocaine instillation required additional medication, regional anaesthesia, or general anaesthesia than those in the placebo group (RR 0.11, 95% CI 0.03 to 0.42; 1 RCT, 40 women; Analysis 5.2).
4. Combination of interventions versus single intervention
4.1 Combination of lidocaine instillation and IM morphine versus instillation of lidocaine alone
A single study, involving 40 women, measured outcomes for this comparison (Visalyaputra 1999).
Primary outcome
Intraperitoneal pain
There was no clear difference in pain relief between the groups (MD ‐0.40, 95% CI ‐1.52 to 0.72; 1 RCT, 40 women; Analysis 6.1).
Secondary outcomes
Adverse effects
There were no adverse events observed in this comparison.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
There was no clear difference in the number of women who required additional medication, regional anaesthesia, or general anaesthesia between the groups (RR 0.50, 95% CI 0.10 to 2.43, 1 RCT, 40 women; Analysis 6.2).
4.2 Combination of lidocaine instillation and IM morphine versus IM morphine alone
A single study, involving 40 women, measured outcomes for this comparison (Visalyaputra 1999).
Primary outcome
Intraperitoneal pain
Women who received a combination of lidocaine instillation and IM morphine reported less pain than those who received IM morphine alone (MD ‐5.20, 95% CI ‐6.63 to ‐3.77; 1 RCT, 40 women; Analysis 7.1).
Secondary outcomes
Adverse effects
Two women who received IM morphine alone complained of vomiting; no women who received a combination of lidocaine and IM morphine reported any adverse effects.
Requirement for additional medication, regional anaesthesia, or general anaesthesia
Significantly fewer women who received a combination of lidocaine plus IM morphine required additional medication, regional anaesthesia, or general anaesthesia than those who received IM morphine alone (RR 0.11, 95% CI 0.03 to 0.42; 1 RCT, 40 women; Analysis 7.2).
Discusión
Resumen de los resultados principales
Los resultados de esta revisión se basan en tres ECA pequeños que analizaron en total 230 LTPM bajo anestesia local. Uno de los estudios evaluó la intensidad del dolor durante la entrada al abdomen y comparó los resultados de las pacientes a las que se les aplicó crema EMLA antes de la incisión y los de las pacientes a las que se les aplicó crema placebo. Las intervenciones para el alivio del dolor intraperitoneal evaluadas en los tres estudios consistieron en la instilación intraperitoneal de diversas concentraciones de lidocaína, una inyección intramuscular de morfina o una combinación de instilación intraperitoneal de lidocaína y una inyección intramuscular de morfina. Sin embargo, la mayoría de los resultados de la revisión se basan en un número pequeño de pacientes de un único estudio pequeño.
Se observaron los siguientes hallazgos principales:
-
La crema EMLA, un agente anestésico tópico, alivió de manera significativa el dolor durante la entrada al abdomen más que el placebo, como se demuestra por una intensidad menor del dolor durante una prueba de dolor realizada mediante pinzas (Análisis 1.1), y redujo de manera significativa la necesidad de lidocaína subcutánea durante el procedimiento (Análisis 1.2).
-
Las pacientes que recibieron una instilación intraperitoneal de lidocaína (independientemente de la dosis) presentaron una intensidad del dolor intraperitoneal mucho menor que las que recibieron placebo (Análisis 2.1), o morfina IM (Análisis 4.1). El agregado de morfina IM a una instilación intraperitoneal de lidocaína no alivió claramente el dolor intraperitoneal en comparación con la instilación intraperitoneal de lidocaína sola (Análisis 6.1). Una inyección intramuscular de morfina sola no fue efectiva para el alivio del dolor intraperitoneal en comparación con placebo (Análisis 3.1).
-
Los efectos adversos de las técnicas anestésicas locales evaluadas en los estudios incluidos fueron relativamente poco frecuentes y no se informaron efectos adversos graves, solo vómitos y mareos.
Compleción y aplicabilidad general de las pruebas
El resultado primario de esta revisión fue la intensidad del dolor durante la LTPM. Solo un estudio incluido midió el dolor durante la incisión para la entrada al abdomen. Todos los estudios incluidos informaron de la intensidad del dolor intraperitoneal pocos minutos después de la instilación de lidocaína. Visalyaputra 1999 evaluó el dolor intraperitoneal tres minutos después de la instilación. Los otros dos estudios evaluaron el dolor intraperitoneal un minuto después de la instilación. Los resultados secundarios de interés en esta revisión incluyeron los efectos adversos perioperatorios y el número de pacientes que necesitaron medicación adicional, anestesia regional o anestesia general para el alivio del dolor durante el procedimiento. Ninguno de los estudios informó sobre la gravedad de los efectos adversos. Visalyaputra 1999 y Visalyaputra 2002 describieron su protocolo para evaluar los efectos adversos durante el procedimiento, pero Ratanalappaiboon 2012 no lo hizo, lo que puede hacer que exista incertidumbre acerca de los efectos adversos informados en este estudio incluido. Todos los estudios incluidos informaron de la cantidad de pacientes que necesitaron medicación adicional, anestesia regional o anestesia general para el alivio del dolor durante el procedimiento. Ninguno de los estudios informó sobre las medidas de satisfacción.
Aunque las intervenciones evaluadas en esta revisión variaron entre los estudios, la intervención principal fue la instilación intraperitoneal de lidocaína sola o combinada con una inyección de morfina. Además, ninguno de los estudios incluidos proporcionó analgesia preventiva (iniciación de un agente anestésico antes de la incisión quirúrgica), que se ha considerado una estrategia alentadora para un mejor control del dolor durante el período perioperatorio (Campiglia 2010). Por lo tanto, la evidencia presentada no es aplicable a las pacientes sometidas a diferentes técnicas anestésicas locales (es decir, inyección de agentes anestésicos en el mesosálpinx, o pacientes a las que se les administran agentes analgésicos preventivo).
Esta revisión solo incluyó estudios que evaluaron la efectividad y la seguridad de las técnicas anestésicas locales para el alivio del dolor durante la ligadura de las trompas uterinas posparto mediante minilaparotomía, por lo que no es posible generalizar los resultados de la revisión a las pacientes que no están en el período posparto y se someten a procedimientos de ligadura de las trompas uterinas de intervalo.
Una revisión sistemática anterior observó una tasa considerablemente alta de mortalidad relacionada con la anestesia entre pacientes en contextos de bajos recursos, que se explica en parte por la incapacidad para apoyar inversiones en la tecnología, las técnicas y el adiestramiento necesarios para mejorar la seguridad de los pacientes (Bainbridge 2012). La fortaleza de esta revisión es que abordó una pregunta clínicamente relevante y pragmática para los países de ingresos bajos y medianos (PIBM). Esta revisión, que incluyó tres estudios realizados en Tailandia, indicó que la instilación intraperitoneal de un agente anestésico local podría ser un método anestésico aceptable que podría ofrecer un buen control del dolor para las pacientes sometidas a LTPM.
Los resultados de la revisión se pueden aplicar a otros PIBM, ya que la instilación intraperitoneal de agentes anestésicos locales es un método fácil, barato y menos invasivo que no requiere de un anestesiólogo o de un equipo anestésico avanzado. Por lo tanto, esta intervención pondría la LTPM al alcance de más mujeres en un contexto de PIBM que desean la esterilización.
Calidad de la evidencia
La principal limitación de esta revisión es que solo se identificaron tres ECA pequeños, con un total de 230 mujeres. La mayoría de los análisis se basaron en un número pequeño de estudios y mujeres. Al utilizar los criterios GRADE, la certeza general de la evidencia en esta revisión se consideró baja a muy baja. La certeza de la evidencia se disminuyó a baja para todas las comparaciones de instilación intraperitoneal de lidocaína versus placebo u otras intervenciones debido al riesgo incierto de sesgo de selección en dos de los tres estudios y a la imprecisión de las estimaciones informadas (Visalyaputra 1999; Visalyaputra 2002). La evidencia se disminuyó a certeza muy baja para los efectos adversos en todas las comparaciones debido al riesgo incierto de sesgo de selección en dos de los tres estudios incluidos y a la imprecisión de los datos. Otra posible fuente de sesgo fue que un estudio no tuvo un protocolo bien definido para la evaluación de los efectos adversos, lo que puede haber repercutido en la credibilidad de los datos informados (Ratanalappaiboon 2012).
Sesgos potenciales en el proceso de revisión
Se realizó una búsqueda exhaustiva de la literatura gris, de las actas de congresos, libros de texto clave, listas de citas de estudios incluidos y de las bases de datos registradas de ensayos en curso, con la asistencia del especialista en información del Grupo Cochrane de Ginecología y Fertilidad. Se siguieron las normas MECIR, que son requisitos metodológicos para la preparación de los Protocolos y las Revisiones Cochrane (Higgins 2016).
Sin embargo, no fue posible determinar la posibilidad de sesgo de informe ni evaluar la heterogeneidad debido a los números limitados de estudios para cada resultado. YW fue coautor de uno de los estudios incluidos (Ratanalappaiboon 2012). El posible sesgo se redujo al mínimo al invitar a PL a que evaluara el riesgo de sesgo y extrajera los datos de este estudio incluido. Ninguno de los autores de la revisión tiene vínculos con compañías farmacéuticas ni un interés económico en la prescripción de la medicación evaluada.
Acuerdos y desacuerdos con otros estudios o revisiones
Hasta donde se conoce esta es la primera revisión sistemática realizada para evaluar la efectividad y los efectos adversos de las técnicas anestésicas locales para el control del dolor durante la LTPM. La evidencia que se encontró en la presente revisión indicó que la instilación intraperitoneal de un agente anestésico local proporcionó buena analgesia, sin ningún efecto adverso grave informado.
El uso de una combinación de agentes analgésicos con diferentes mecanismos (analgesia multimodal) puede mejorar el control del dolor mediante efectos sinérgicos entre los agentes utilizados (Elvir‐Lazo 2010; Gritsenko 2014). Se ha mostrado que el tratamiento del dolor perioperatorio con múltiples agentes analgésicos ofrece una analgesia significativamente mejor que el uso de agentes únicos (Lee 2013; Rafiq 2014). No se encontró que el agregado de una inyección de morfina a la instilación intraperitoneal de lidocaína aliviara claramente el dolor intraperitoneal en comparación con la instilación intraperitoneal de lidocaína sola, pero los resultados se deben interpretar con precaución porque la certeza de esta evidencia es baja.
Study flow diagram
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Comparison 1 EMLA cream versus placebo cream for pain associated with abdominal entry, Outcome 1 Pain during forceps check.
Comparison 1 EMLA cream versus placebo cream for pain associated with abdominal entry, Outcome 2 Number of women requiring lidocaine instillation for rescue medication.
Comparison 2 Lidocaine instillation versus placebo for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 2 Lidocaine instillation versus placebo for intraperitoneal pain, Outcome 2 Adverse events.
Comparison 2 Lidocaine instillation versus placebo for intraperitoneal pain, Outcome 3 Number of women requiring rescue medication.
Comparison 3 IM morphine versus placebo for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 3 IM morphine versus placebo for intraperitoneal pain, Outcome 2 Number of women requiring rescue medication.
Comparison 4 Lidocaine instillation versus IM morphine for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 4 Lidocaine instillation versus IM morphine for intraperitoneal pain, Outcome 2 Number of women requiring rescue medication.
Comparison 5 Lidocaine instillation plus IM morphine versus placebo for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 5 Lidocaine instillation plus IM morphine versus placebo for intraperitoneal pain, Outcome 2 Number of women requiring rescue medication.
Comparison 6 Lidocaine instillation plus IM morphine versus lidocaine instillation alone for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 6 Lidocaine instillation plus IM morphine versus lidocaine instillation alone for intraperitoneal pain, Outcome 2 Number of women requiring rescue medication.
Comparison 7 Lidocaine instillation plus IM morphine versus IM morphine alone for intraperitoneal pain, Outcome 1 Intraperitoneal pain.
Comparison 7 Lidocaine instillation plus IM morphine versus IM morphine alone for intraperitoneal pain, Outcome 2 Number of women requiring rescue medication.
| EMLA cream compared to placebo cream for pain during abdominal entry | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia Settings: inpatient settings; tertiary hospitals Intervention: EMLA cream Comparison: placebo cream | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of women | Certainty of the evidence | Comments | |
| Risk with placebo | Risk with EMLA cream | |||||
| Pain during abdominal entry (NRS; higher = more pain) | The mean pain score with placebo cream during abdominal entry was 4.6 | The mean pain score with EMLA cream was 3.18 lower (4.10 lower to 2.26 lower) | ‐ | 90 | ⊕⊕⊝⊝ | MD ‐3.18, 95% CI ‐4.10 to ‐2.26 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 90 | ⊕⊝⊝⊝ | No reported adverse events occurred for this comparison |
| Number of women requiring rescue medication | 1000 per 1000 | 360 per 1000 (250 to 530) | RR 0.36 (0.25 to 0.53) | 90 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). NRS: numeric rating scale; CI: confidence interval; RR: risk ratio; MD: mean difference | ||||||
| GRADEs (certainty) of the evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine instillation compared to placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with placebo instillation (normal saline) | Risk with lidocaine instillation | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score in the lidocaine was 3.34 lower | ‐ | 190 | ⊕⊕⊝⊝ | MD ‐3.34, 95% CI ‐4.19 to ‐2.49 |
| Adverse events within 48 hours post operation | 100 per 1000 | 104 per 1000 | RR 1.04 | 150 | ⊕⊝⊝⊝ | |
| Number of women requiring rescue medication | 543 per 1000 | 147 per 1000 | RR 0.27 | 190 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for other potential risk of bias, as one study did have not a well‐defined protocol for assessing adverse events, which might have impacted the reliability of reported results. 3 Downgraded two levels for very serious imprecision (due to wide confidence intervals including benefit and harm, and sparseness of reported events) | ||||||
| Intramuscular (IM) morphine compared to IM placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM placebo | Risk with IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score with IM morphine was 0.5 higher | ‐ | 40 | ⊕⊕⊝⊝ | MD 0.50, 95% CI ‐1.33 to 2.33 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were 2 cases of vomiting in the IM morphine group, and no adverse events in the placebo group. |
| Number of women requiring rescue medication | 900 per 1000 | 900 per 1000 | RR 1.00 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Intraperitoneal lidocaine instillation compared to intramuscular (IM) morphine for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM morphine | Risk with lidocaine instillation | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the morphine group was 6.0 | The mean intraperitoneal pain score in the lidocaine group was 4.8 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐4.80, 95% CI ‐6.43 to ‐3.17 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were 2 cases of vomiting in the IM morphine group, and no adverse events in the placebo group. |
| Number of women requiring rescue medication | 900 per 1000 | 198 per 1000 | RR 0.22 (0.09 to 0.54) | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Intraperitoneal lidocaine instillation plus intramuscular (IM) morphine administration compared to placebo for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with placebo | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the placebo group was 5.5 | The mean intraperitoneal pain score in the lidocaine and morphine group was 4.7 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐4.70, 95% CI ‐6.09 to ‐3.31 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | No adverse events occurred for this comparison |
| Number of women requiring rescue medication | 900 per 1000 | 99 per 1000 | RR 0.11 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine intraperitoneal instillation plus intramuscular (IM) morphine compared to lidocaine intraperitoneal instillation alone for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing PPTL under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with lidocaine instillation alone | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the lidocaine alone group was 1.2 | The mean intraperitoneal pain score in the lidocaine plus morphine group was 0.4 lower | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐0.40, 95% CI ‐1.52 to 0.72 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | No adverse events occurred for this comparison |
| Number of women requiring rescue medication | 200 per 1000 | 100 per 1000 | RR 0.50 | 40 | ⊕⊝⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Lidocaine intraperitoneal instillation plus intramuscular (IM) morphine compared to IM morphine alone for intra‐operative intraperitoneal pain relief | ||||||
| Patient or population: women undergoing postpartum mini‐laparotomy tubal ligation (PPTL) under local anaesthesia | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of women | Certainty of the evidence | Comments | |
| Risk with IM morphine alone | Risk with lidocaine instillation plus IM morphine | |||||
| Intraperitoneal pain (NRS; higher = more pain) | The mean intraperitoneal pain score in the IM morphine alone group was 6.0 | The mean intraperitoneal pain score in the lidocaine plus morphine group was 5.2 lower (6.63 lower to 3.77 lower) | ‐ | 40 | ⊕⊕⊝⊝ | MD ‐5.20, 95% CI ‐6.63 to ‐3.77 |
| Adverse events within 48 hours post operation | See comment | See comment | ‐ | 40 | ⊕⊝⊝⊝ | There were only two cases of vomiting in the IM morphine group, and no adverse events in the lidocaine plus morphine group |
| Number of women requiring rescue medication | 900 per 1000 | 99 per 1000 | RR 0.11 | 40 | ⊕⊕⊝⊝ | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADEs (certainty) of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
| 1Downgraded one level for unclear risk of selection bias 2Downgraded one level for imprecision of the data 3Downgraded two levels for serious imprecision of the data and/or sparseness of reported events | ||||||
| Comparision I Lidocaine instillation versus placebo | Lidocaine group (N = 120) | Placebo group (N = 70) |
| Required regional or general anaesthesia | 1 (0.83) | 22 (31.43) |
| Comparison II An intramuscular injection of morphine versus placebo | Morphine group (N = 20) | Placebo group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 2 (10.0) |
| Comparison III Intraperitoneal instillation of lidocaine with IM morphine | Lidocaine group (N = 20) | Morphine group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 4 (20.0) |
| Comparison IV Intraperitoneal instillation of lidocaine combined with an injection of morphine versus placebo | Lidocaine plus morphine group (N = 20) | Placebo group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 2 (10.0) |
| Comparison V Intraperitoneal instillation of lidocaine combined with an injection of morphine versus intraperitoneal instillation of lidocaine alone | Lidocaine plus morphine group (N = 20) | Lidocaine alone group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 1 (5.0) |
| Comparison VI Intraperitoneal instillation of lidocaine combined with an injection of morphine versus an injection of morphine alone | Lidocaine plus morphine group (N = 20) | Morphine alone group (N = 20) |
| Required regional or general anaesthesia | 0 (0) | 0 (0) |
| Data are present as number of women (percentage) | ||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Pain during forceps check Show forest plot | 1 | 90 | Mean Difference (IV, Fixed, 95% CI) | ‐3.18 [‐4.10, ‐2.26] |
| 2 Number of women requiring lidocaine instillation for rescue medication Show forest plot | 1 | 90 | Risk Ratio (IV, Fixed, 95% CI) | 0.36 [0.25, 0.53] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 3 | 190 | Mean Difference (IV, Fixed, 95% CI) | ‐3.34 [‐4.19, ‐2.49] |
| 2 Adverse events Show forest plot | 2 | 150 | Risk Ratio (IV, Fixed, 95% CI) | 1.04 [0.40, 2.69] |
| 3 Number of women requiring rescue medication Show forest plot | 3 | 190 | Risk Ratio (IV, Fixed, 95% CI) | 0.27 [0.17, 0.44] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | 0.5 [‐1.33, 2.33] |
| 2 Number of women requiring rescue medication Show forest plot | 1 | 40 | Risk Ratio (IV, Fixed, 95% CI) | 1.0 [0.81, 1.23] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐4.8 [‐6.43, ‐3.17] |
| 2 Number of women requiring rescue medication Show forest plot | 1 | 40 | Risk Ratio (IV, Fixed, 95% CI) | 0.22 [0.09, 0.54] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐4.70 [‐6.09, ‐3.31] |
| 2 Number of women requiring rescue medication Show forest plot | 1 | 40 | Risk Ratio (IV, Fixed, 95% CI) | 0.11 [0.03, 0.42] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐0.40 [‐1.52, 0.72] |
| 2 Number of women requiring rescue medication Show forest plot | 1 | 40 | Risk Ratio (IV, Fixed, 95% CI) | 0.5 [0.10, 2.43] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Intraperitoneal pain Show forest plot | 1 | 40 | Mean Difference (IV, Fixed, 95% CI) | ‐5.2 [‐6.63, ‐3.77] |
| 2 Number of women requiring rescue medication Show forest plot | 1 | 40 | Risk Ratio (IV, Fixed, 95% CI) | 0.11 [0.03, 0.42] |
