Anestesia paravertebral con o sin sedación versus anestesia general para mujeres sometidas a cirugía por cáncer de mama
Información
- DOI:
- https://doi.org/10.1002/14651858.CD012968.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 25 febrero 2021see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Cáncer de mama
- Copyright:
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- Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
AC, HP, AS, and MK drafted the protocol. All review authors read and approved the final review version.
Sources of support
Internal sources
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All India Institute of Medical Sciences, New Delhi, India
Tertiary level hospital and research institute
External sources
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None, India
Declarations of interest
AC has registered for PhD thesis titled "Effect of paravertebral anaesthesia on quality of life scores and circulating tumour cells in breast cancer patients". AC has no known conflicts of interest.
ARC has no known conflicts of interest.
HP has no known conflicts of interest.
RS is co‐guide for the above mentioned thesis. RS has no known conflicts of interest.
MKA has no known conflicts of interest.
AS is co‐guide of the above mentioned PhD thesis. AS has no known conflicts of interest.
MK has no known conflicts of interest.
Acknowledgements
We would like to thank Melina Willson (Managing Editor) for her constant, tireless help right from title registration to protocol development; Nicholas Wilcken and Annabel Goodwin (Co‐ordinating Editors) for their help in improving the manuscript; and Ava Grace Tan‐Koay/Slavica Berber for assistance in developing a search strategy. We would also like to acknowledge our peer reviewers ‐ Sam Egger (Statistical Editor), Matthew Rucklidge (Expert Clinical Reviewer), Sara Yaron (Consumer), and Dana Stewart (Consumer) ‐ who assisted during preparation of the protocol for this systematic review.
We would like to acknowledge our peer reviewers: Theresa Moore (Cochrane Methodological Editor), Laurence Gluch (Expert Clinical Reviewer), and Dana Stewart (Consumer) for their help during preparation of this review.
We would like to thank Tashtanbekova Cholpon Bolotbekovna, Junior Researcher Scientist, Educational‐Scientific Center Evidence‐Based Medicine Cochrane Russia, Institute of Medicine and Biology, at Kazan Federal University, for help in translating the Shkol'nik 2006 study from the Russian language to the English language for the purpose of this review.
We would like to thank Paulina Sitarek, Junior Associate with Rasiewicz Oleksyn & Associates, Warsaw, Mazowieckie, Poland, for confirming translation of the Paleczny 2005 study from the Polish language to the English language. Initial translation was done using Google Translate software.
Version history
| Published | Title | Stage | Authors | Version |
| 2021 Feb 25 | Paravertebral anaesthesia with or without sedation versus general anaesthesia for women undergoing breast cancer surgery | Review | Anjolie Chhabra, Apala Roy Chowdhury, Hemanshu Prabhakar, Rajeshwari Subramaniam, Mahesh Kumar Arora, Anurag Srivastava, Mani Kalaivani | |
| 2018 Feb 24 | Paravertebral anaesthesia with or without sedation versus general anaesthesia for women undergoing breast cancer surgery | Protocol | Anjolie Chhabra, Hemanshu Prabhakar, Rajeshwari Subramaniam, Mahesh Kumar Arora, Anurag Srivastava, Mani Kalaivani | |
Differences between protocol and review
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The primary outcome of quality of recovery during the initial postoperative period (1 to 3 days) using validated questionnaires was not reported by any study. However, studies assessed the factors that determine quality of recovery such as postoperative analgesic use, PONV, duration of hospital stay, time to ambulation, and patient satisfaction. Therefore these reported outcomes were included in the review to determine quality of recovery over 1 to 2 postoperative days.
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The outcome of postoperative pain at rest on the first postoperative day using a visual analogue scale (VAS) with a range of 0 to 10, or 0 to 100, or a numerical rating scale (NRS) with a similar range, was assessed as ‘Postoperative pain at rest on the first postoperative day at 2 hours, 6 and 24 hours’ so as to better assess this outcome.
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The outcome of postoperative pain on movement on the first postoperative day using a visual analogue scale (VAS) with a range of 0 to 10, or 0 to 100, or a numerical rating scale (NRS) with a similar range, was specified as ‘Postoperative pain on movement on the first postoperative day at 2 hours, 6 and 24 hours’ so as to better assess this outcome.
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The secondary outcome of 'Adverse events due to the paravertebral block (i.e. hypotension, bilateral block, pneumothorax, Horner's syndrome, bleeding, neurological deficit)' was changed to ‘Adverse events due to the paravertebral block (i.e. epidural spread and bilateral block, Horner's syndrome, bleeding, pleural tap)'. Pleural tap is more likely to occur following paravertebral block and may not be followed by pneumothorax.
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We planned to conduct a subgroup analysis to assess the effect of (a) breast tumour receptor status on the clinical outcome of disease‐free survival, and (b) primary surgery compared to surgery following chemotherapy on clinical outcomes, namely, quality of recovery, disease‐free survival, and quality of life. This was not possible due to the paucity of literature. Instead, we performed a subgroup analysis on paravertebral block with local anaesthetics alone or with the additive drug clonidine.
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We planned to conduct a sensitivity analysis for ‘absence of blinding in patient‐reported outcomes’. However, blinding of participants and personnel was not possible in any study, as one group of participants had received general anaesthesia and the other paravertebral anaesthesia. As this was the main question of the review, this was considered to be acceptable by all review authors.
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For outcomes for which numerical data were lacking or for outcomes that had been measured in diverse ways, vote counting based on the direction of effect was used, and results were reported using the synthesis without meta analysis (SWiM) approach. As far as possible, this was done alongside the meta‐analysis.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Analgesia [*methods];
- Anesthesia Recovery Period;
- Anesthesia, General [*methods];
- Anesthesia, Spinal [adverse effects, *methods];
- Bias;
- Breast Neoplasms [immunology, *surgery];
- Early Ambulation;
- Horner Syndrome [epidemiology];
- Incidence;
- Intention to Treat Analysis;
- Length of Stay;
- Nerve Block [methods];
- Pain Measurement [methods];
- Pain, Postoperative [diagnosis, prevention & control];
- Patient Satisfaction;
- Postoperative Nausea and Vomiting [epidemiology, prevention & control];
- Randomized Controlled Trials as Topic;
- Stress, Physiological [*drug effects];
Medical Subject Headings Check Words
Adult; Female; Humans;
PICO
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
a = Random sequence generation (selection bias), b = Concealment of the allocated sequence (selection bias), c = Blinding of participants and personnel (performance bias), d = Blinding of outcome assessment (detection bias), e = Incomplete outcome data (attrition bias), f = Selective outcome reporting (reporting bias), g = Other potential sources of bias.
a = Random sequence generation (selection bias), b = Concealment of the allocated sequence (selection bias), c = Blinding of participants and personnel (performance bias), d = Blinding of outcome assessment (detection bias), e = Incomplete outcome data (attrition bias), f = Selective outcome reporting (reporting bias), g = Other potential sources of bias.
a = Random sequence generation (selection bias), b = Concealment of the allocated sequence (selection bias), c = Blinding of participants and personnel (performance bias), d = Blinding of outcome assessment (detection bias), e = Incomplete outcome data (attrition bias), f = Selective outcome reporting (reporting bias), g = Other potential sources of bias.
a = Random sequence generation (selection bias), b = Concealment of the allocated sequence (selection bias), c = Blinding of participants and personnel (performance bias), d = Blinding of outcome assessment (detection bias), e = Incomplete outcome data (attrition bias), f = Selective outcome reporting (reporting bias), g = Other potential sources of bias.
a = Random sequence generation (selection bias), b = Concealment of the allocated sequence (selection bias), c = Blinding of participants and personnel (performance bias), d = Blinding of outcome assessment (detection bias), e = Incomplete outcome data (attrition bias), f = Selective outcome reporting (reporting bias), g = Other potential sources of bias.
Comparison 1: Postoperative outcomes, Outcome 1: Postoperative analgesic requirement
Comparison 1: Postoperative outcomes, Outcome 2: Postoperative nausea and vomiting
Comparison 1: Postoperative outcomes, Outcome 3: Hospital stay
Comparison 1: Postoperative outcomes, Outcome 4: Patient satisfaction score
Comparison 1: Postoperative outcomes, Outcome 5: Postoperative pain (VAS) at 2 hours
Comparison 1: Postoperative outcomes, Outcome 6: Postoperative pain (VAS) at 6 hours at rest
Comparison 1: Postoperative outcomes, Outcome 7: Postoperative pain (VAS) at 24 hours at rest
Comparison 1: Postoperative outcomes, Outcome 8: Postoperative pain (VAS) at 6 hours on movement
Comparison 1: Postoperative outcomes, Outcome 9: Postoperative pain (VAS) at 24 hours on movement
Comparison 2: Adverse events, Outcome 1: Epidural spread
| Paravertebral anaesthesia with or without sedation compared to general anaesthesia for women undergoing breast cancer surgery | ||||||
| Patient or population: women undergoing breast cancer surgery | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | №. of participants | Certainty of evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with general anaesthesia | Risk with paravertebral anaesthesia with or without sedation | |||||
| Postoperative analgesic requirement | Study population | OR 0.07 | 305 | ⊕⊕⊝⊝ | ||
| 480 per 1000 | 61 per 1000 | |||||
| Postoperative nausea and vomiting (PONV) | Study population | OR 0.16 | 323 | ⊕⊕⊕⊝ | ||
| 340 per 1000 | 72 per 1000 | |||||
| Postoperative pain at 2 hours | Mean postoperative pain at 2 hours was 0 | MD 2.95 lower | ‐ | 224 | ⊕⊕⊕⊝ | |
| Postoperative pain at 24 hours on rest | Mean postoperative pain at 24 hours on rest was 0 | MD 0.21 lower | ‐ | 169 | ⊕⊕⊝⊝ | |
| Postoperative pain at 6 hours on movement | Mean postoperative pain at 6 hours on movement was 0 | MD 2.57 lower | ‐ | 130 | ⊕⊕⊝⊝ | |
| Postoperative pain at 24 hours on movement | Mean postoperative pain at 24 hours on movement was 0 | MD 2.12 lower | ‐ | 130 | ⊕⊕⊝⊝ | |
| Mortality | Study population | not estimable | (9 RCTs) | ‐ | No RCT has studied this outcome; therefore no data are available | |
| 0 per 1000 | 0 per 1000 | |||||
| *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). | ||||||
| GRADE Working Group grades of evidence. | ||||||
| aData from five studies were analysed to assess this outcome (Das 2012; Naja 2003; Pusch 1999; Sundarathiti 2015; Terheggen 2002). Blinding of participants was not possible as participants in one group received paravertebral anaesthesia for breast cancer surgery and participants in the other group received general anaesthesia. This comparison was the main question of the review; therefore it was acceptable. Uncertainty about random sequence generation in four studies (Das 2012; Naja 2003; Pusch 1999; Terheggen 2002), allocation concealment in two studies (Pusch 1999; Sundarathiti 2015), and blinding of outcome assessors in one study led to downgrading of risk of bias to serious (Naja 2003). bHeterogeneity was observed for this outcome (I² = 70%) that included five RCTs; with the exclusion of 1 study, Sundarathiti 2015, heterogeneity decreased to 0%, probably because in this study, all patients in both groups received analgesics (Ultracet and Celebrex twice a day) irrespective of pain; only when they needed additional postoperative analgesia were morphine boluses administered. This routine administration of analgesics could have masked the difference in analgesic requirements between groups. In the other four studies, analgesics were administered only when patients expressed that they were in pain. cData from six studies were analysed to assess this outcome (Das 2012; Naja 2003; Paleczny 2005; Pusch 1999; Tedore 2011; Terheggen 2002). Blinding of participants or personnel was not possible, as participants in one group received paravertebral anaesthesia for breast cancer surgery and participants in the other group received general anaesthesia. This comparison was the main question of the review; therefore it was acceptable. Uncertainty about random sequence generation in five studies (Das 2012; Naja 2003; Paleczny 2005; Pusch 1999; Terheggen 2002), allocation concealment in two studies (Paleczny 2005; Pusch 1999), and blinding of outcome assessors in two studies led to downgrading of risk of bias to serious (Naja 2003; Paleczny 2005). dData from four studies were analysed to assess this outcome (Das 2012; Paleczny 2005; Pusch 1999; Terheggen 2002). Blinding of participants or personnel was not possible as participants in one group received paravertebral anaesthesia for breast cancer surgery and participants in the other group received general anaesthesia. This comparison was the main question of the review; therefore it was acceptable. Uncertainty about random sequence generation in all four studies (Das 2012; Paleczny 2005; Pusch 1999; Terheggen 2002), allocation concealment in two studies (Paleczny 2005; Pusch 1999), and blinding of outcome assessors in one study led to downgrading of risk of bias to serious (Paleczny 2005). eData from five studies were analysed to assess this outcome (Das 2012; Naja 2003; Paleczny 2005; Sundarathiti 2015; Tedore 2011). Blinding of participants was not possible, as participants in one group received paravertebral anaesthesia for breast cancer surgery and participants in the other group received general anaesthesia. This comparison was the main question of the review; therefore it was acceptable. Uncertainty about random sequence generation in three studies (Das 2012; Naja 2003; Paleczny 2005), allocation concealment in two studies (Paleczny 2005; Sundarathiti 2015), and blinding of outcome assessors in two studies led to downgrading of risk of bias to serious (Naja 2003; Paleczny 2005). fData from five studies were used to evaluate this outcome (Das 2012; Naja 2003; Paleczny 2005; Sundarathiti 2015; Tedore 2011). We noted heterogeneity for this outcome (I² = 96%). On performing subgroup analysis and excluding two studies (Naja 2003; Paleczny 2005), where a potent adjunctive drug (alpha‐2 agonist clonidine) was added to the local anaesthetic solution used for paravertebral anaesthesia, we found a reduction in heterogeneity. gData from two studies were used to analyse this outcome (Naja 2003; Sundarathiti 2015). Blinding of participants or personnel was not possible, as participants in one group received paravertebral anaesthesia for breast cancer surgery and participants in the other group received general anaesthesia. This comparison was the main question of the review; therefore it is acceptable. Uncertainty about random sequence generation and blinding of outcome assessors in one study ‐ Naja 2003 ‐ and allocation concealment in the other study ‐ Sundarathiti 2015 ‐ led to downgrading of evidence to serious. hSignificant heterogeneity was noted in the results and sensitivity analysis could not be performed, as only two studies could be included in assessing this outcome (Naja 2003; Sundarathiti 2015). Both studies showed reduction in pain on movement with the paravertebral block, but one study showed a greater reduction in pain probably due to methodological differences (Naja 2003). The use of clonidine as an adjunct to local anaesthetic as well as multiple injections at each paravertebral level could have contributed to this effect (Naja 2003). In the other study, only local anaesthetic was administered in the paravertebral space, injection was performed at one level, a catheter was inserted 8 cm into the space, and drug was injected through the catheter at this point, as well as on withdrawing the catheter by 2 cm and then 4 cm (single‐injection, multi‐level block) (Sundarathiti 2015). | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Postoperative analgesic requirement Show forest plot | 5 | 305 | Odds Ratio (M‐H, Random, 95% CI) | 0.07 [0.01, 0.34] |
| 1.2 Postoperative nausea and vomiting Show forest plot | 6 | 324 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.16 [0.08, 0.31] |
| 1.3 Hospital stay Show forest plot | 3 | 174 | Mean Difference (IV, Random, 95% CI) | ‐79.39 [‐107.38, ‐51.40] |
| 1.4 Patient satisfaction score Show forest plot | 3 | 129 | Mean Difference (IV, Fixed, 95% CI) | 5.52 [1.30, 9.75] |
| 1.5 Postoperative pain (VAS) at 2 hours Show forest plot | 4 | 224 | Mean Difference (IV, Random, 95% CI) | ‐2.95 [‐3.37, ‐2.54] |
| 1.6 Postoperative pain (VAS) at 6 hours at rest Show forest plot | 5 | 324 | Mean Difference (IV, Random, 95% CI) | ‐1.54 [‐3.20, 0.11] |
| 1.7 Postoperative pain (VAS) at 24 hours at rest Show forest plot | 5 | 278 | Mean Difference (IV, Random, 95% CI) | ‐1.19 [‐2.27, ‐0.10] |
| 1.8 Postoperative pain (VAS) at 6 hours on movement Show forest plot | 2 | 130 | Mean Difference (IV, Random, 95% CI) | ‐2.57 [‐3.97, ‐1.17] |
| 1.9 Postoperative pain (VAS) at 24 hours on movement Show forest plot | 2 | 130 | Mean Difference (IV, Random, 95% CI) | ‐2.12 [‐4.80, 0.55] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Epidural spread Show forest plot | 8 | 574 | Risk Difference (M‐H, Random, 95% CI) | 0.00 [‐0.01, 0.02] |
