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Cochrane Database of Systematic Reviews

طراحی‌ قطر (gauge) و سر سوزن برای پیشگیری از سردرد متعاقب بی‌حسی نخاعی (PDPH)

Información

DOI:
https://doi.org/10.1002/14651858.CD010807.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 07 abril 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Anestesia

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Ingrid Arevalo‐Rodriguez

    Correspondencia a: Cochrane Ecuador. Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC). Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador

    [email protected]

    [email protected]

    Division of Research, Fundacion Universitaria de Ciencias de la Salud ‐ Hospital de San Jose/Hospital Infantil de San Jose, Bogotá D.C., Colombia

  • Luis Muñoz

    Department of Anaesthesia, Hospital de San José, Fundación Universitaria de Ciencias de la Salud, Bogotá D.C., Colombia

  • Natalia Godoy‐Casasbuenas

    Division of Research, Fundación Universitaria de Ciencias de la Salud ‐ Hospital de San José/Hospital Infantil de San José, Bogotá, Colombia

  • Agustín Ciapponi

    Argentine Cochrane Centre, Institute for Clinical Effectiveness and Health Policy (IECS‐CONICET), Buenos Aires, Argentina

  • Jimmy J Arevalo

    Department of Anaesthesia, Hospital de San José, Fundación Universitaria de Ciencias de la Salud, Bogotá D.C., Colombia

    Department of Anesthesiology, VU University Medical Center, Amsterdam, Netherlands

  • Sabine Boogaard

    Department of Anesthesiology, VU University Medical Center, Amsterdam, Netherlands

  • Marta Roqué i Figuls

    Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain

Contributions of authors

Ingrid Arevalo‐Rodriguez: (IA‐R), Luis Muñoz (LM), Natalia Godoy‐Casasbuenas (NG‐C), Jimmy J Arevalo (JJA), Sabine Boogaard (SB), Agustín Ciapponi (AC), Marta Roqué i Figul (MRF)

Conceiving the review: IA‐R, LM

Designing the review: IA‐R, LM, JJA, AC, MRF

Co‐ordinating the review: IA‐R

Undertaking manual searches: IA‐R, NG‐C

Screening search results: IA‐R, LM, JJA, NG‐C

Organizing retrieval of papers: LM, NG‐C

Screening retrieved papers against inclusion criteria: IA‐R, LM, JJA, AC, MRF, NG‐C, SB

Appraising quality of papers: IA‐R, LM, SB, AC, MRF, NG‐C

Abstracting data from papers: LM, JJA, NG‐C, IAR

Writing to authors of papers for additional information: IAR

Providing additional data about papers: IA‐R, AC

Obtaining and screening data on unpublished studies: IA‐R, LM

Providing data management for the review: RM, IAR

Entering data into Review Manager (RevMan 5.3): IA‐R, LM, NG‐C

Managing RevMan statistical data: MRF, IAR

Performing other statistical analyses not using RevMan: MR

Ensuring double entry of data (data entered by person one: MRF; data entered by person two: IA‐R)

Interpreting data: IA‐R, LM, AC, MRF, NG‐C

Making statistical inferences: IA‐R, LM, AC, MRF

Writing the review: IA‐R, LM, JJA, AC, MRF, NG‐C, SB

Providing guidance on the review: AC, MRF

Securing funding for the review: IA‐R

Performing previous work that served as the foundation of the present study: IA‐R, LM, AC, MRF

Serving as guarantor for the review (one author): IA‐R

Taking responsibility for reading and checking the review before submission:IA‐R, LM, JJA, AC, MRF, NG‐C, SB

Sources of support

Internal sources

  • Fundación Universitaria de Ciencias de la Salud, Bogotá D.C., Colombia.

  • Institute for Clinical Effectiveness and Health Policy IECS, Buenos Aires, Argentina.

  • Iberoamerican Cochrane Centre, Barcelona, Spain.

  • Universidad El Bosque, Bogotá, Colombia.

    Luis Muñoz is a Master of Science degree student at the Department of Clinical Epidemiology of El Bosque University, Bogotá, Colombia.

External sources

  • Agencia de Calidad del Sistema Nacional de Salud, Ministry of Health, Spain.

Declarations of interest

Ingrid Arevalo‐Rodriguez: none known.

Luis Muñoz: none known.

Natalia Godoy‐Casasbuenas: none known.

Jimmy J Arevalo: none known.

Sabine Boogaard: none known

Agustín Ciapponi: none known.

Marta Roqué i Figuls: none known.

Acknowledgements

We would like to thank Bronagh Blackwood (content editor), Vibeke E Horstmann (statistical editor), Stephen Halpern and James D Griffiths (peer reviewers), and Patricia Tong (consumer referee) for their help and editorial advice during the preparation of this systematic review.

We would also like to thank Mathew Zacharias (content editor), Marialena Trivella (statistical editor) and Andrew Moore, Stephen Halpern and Polpun Boonmak (peer reviewers) for their help and editorial advice during the preparation of the protocol for this systematic review. The review authors would also like to thank Arturo Marti‐Carvajal for his support and assistance in the design of this review's search strategies and for giving feedback on this protocol (Arevalo‐Rodriguez 2013a).

Version history

Published

Title

Stage

Authors

Version

2017 Apr 07

Needle gauge and tip designs for preventing post‐dural puncture headache (PDPH)

Review

Ingrid Arevalo‐Rodriguez, Luis Muñoz, Natalia Godoy‐Casasbuenas, Agustín Ciapponi, Jimmy J Arevalo, Sabine Boogaard, Marta Roqué i Figuls

https://doi.org/10.1002/14651858.CD010807.pub2

2013 Oct 29

Needle gauge and tip designs for preventing post‐dural puncture headache (PDPH)

Protocol

Ingrid Arevalo‐Rodriguez, Luis Muñoz, Jimmy J Arevalo, Agustín Ciapponi, Marta Roqué i Figuls

https://doi.org/10.1002/14651858.CD010807

Differences between protocol and review

We made the following changes to the published protocol (Arevalo‐Rodriguez 2013a).

  • Due to heterogeneity in the reporting of adverse events, we chose paraesthesia and backache as the most important adverse events(additional to PDPH) related to needle gauge and tip designs. We extracted all numerical information related to these two events and we reported the results in the corresponding sections.

  • In order to make a comprehensive 'Risk of bias' assessment, we considered seven domains (random sequence generation, allocation concealment, blinding of participants, blinding of outcome assessment, incomplete outcome data, selective reporting and other bias) instead of the six domains planned in our protocol (Arevalo‐Rodriguez 2013a). However, we did not consider blinding of personnel because of the nature of the intervention (lumbar puncture).

  • We did not expect to encounter any unit of analysis issues, as we do not expect to find cross‐over studies or cluster‐randomized trials. However, we did identify four such studies (one cross‐over trial and three parallel‐group studies with punctures instead of patients as the unit of analysis) with our search strategies. We included these trials in our review in the qualitative report, but we did not include their results in our main analyses.

  • Subgroup analysis for age (younger than 18 years of age, older than 65 years of age and 18 to 65 years of age). Due to heterogeneity in the reporting of age, we classified studies into three groups: a) only children; b) no distinctions about age; c) 60 years or more. We analysed the numerical information into these three categories.

  • Subgroup analysis by type of surgery: in participants receiving anaesthesia, we analysed the primary outcome by type of surgical procedure in order to explain all sources of heterogeneity. We identified at least three groups: caesarean section, orthopaedic surgeries and other surgeries. It has been reported that some subgroups of patients, such as obstetric women, have an increased risk of PDPH.

  • We did not use number needed to treat to harm (NNTH) figures to illustrate the harms or benefits of interventions, taking into account the quality of evidence and its limitations.

  • In order to consider all possible studies, we performed a sensitivity analysis to measure the risk difference (RD) in those analyses that presented zero events in both treatment arms; they were then not included in the risk ratio analysis.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

'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.
Figuras y tablas -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.

Funnel plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.
Figuras y tablas -
Figure 5

Funnel plot of comparison: 1 Traumatic needle versus atraumatic needle, outcome: 1.1 PDPH by indication.

Funnel plot of comparison: 3 Atraumatic needles: different gauges, outcome: 3.1 PDPH major gauge versus minor gauge by number.
Figuras y tablas -
Figure 6

Funnel plot of comparison: 3 Atraumatic needles: different gauges, outcome: 3.1 PDPH major gauge versus minor gauge by number.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 1 PDPH by indication.
Figuras y tablas -
Analysis 1.1

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 1 PDPH by indication.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 2 PDPH by gauge.
Figuras y tablas -
Analysis 1.2

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 2 PDPH by gauge.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 3 PDPH by gender.
Figuras y tablas -
Analysis 1.3

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 3 PDPH by gender.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 4 PDPH/anaesthesia: type of surgery.
Figuras y tablas -
Analysis 1.4

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 4 PDPH/anaesthesia: type of surgery.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 5 PDPH by position.
Figuras y tablas -
Analysis 1.5

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 5 PDPH by position.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 6 PDPH by age.
Figuras y tablas -
Analysis 1.6

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 6 PDPH by age.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 7 AE: paraesthesia.
Figuras y tablas -
Analysis 1.7

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 7 AE: paraesthesia.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 8 AE: backache.
Figuras y tablas -
Analysis 1.8

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 8 AE: backache.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 9 Severe PDPH by indication.
Figuras y tablas -
Analysis 1.9

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 9 Severe PDPH by indication.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 10 Any headache by indication.
Figuras y tablas -
Analysis 1.10

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 10 Any headache by indication.

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 11 PDPH sensitivity analysis.
Figuras y tablas -
Analysis 1.11

Comparison 1 Traumatic needle versus atraumatic needle, Outcome 11 PDPH sensitivity analysis.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.
Figuras y tablas -
Analysis 2.1

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 2 PDPH by type of surgery.
Figuras y tablas -
Analysis 2.2

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 2 PDPH by type of surgery.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 3 PDPH by age.
Figuras y tablas -
Analysis 2.3

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 3 PDPH by age.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 4 PDPH by position.
Figuras y tablas -
Analysis 2.4

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 4 PDPH by position.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 5 AE: backache.
Figuras y tablas -
Analysis 2.5

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 5 AE: backache.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 6 Severe PDPH by gauge.
Figuras y tablas -
Analysis 2.6

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 6 Severe PDPH by gauge.

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 7 Any headache.
Figuras y tablas -
Analysis 2.7

Comparison 2 Larger gauge traumatic needles versus smaller gauge traumatic needles, Outcome 7 Any headache.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.
Figuras y tablas -
Analysis 3.1

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 1 PDPH larger gauge vs smaller gauge.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 2 PDPH by type of surgery.
Figuras y tablas -
Analysis 3.2

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 2 PDPH by type of surgery.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 3 PDPH by gender.
Figuras y tablas -
Analysis 3.3

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 3 PDPH by gender.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 4 PDPH by position.
Figuras y tablas -
Analysis 3.4

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 4 PDPH by position.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 5 AE: paraesthesia.
Figuras y tablas -
Analysis 3.5

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 5 AE: paraesthesia.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 6 AE: backache.
Figuras y tablas -
Analysis 3.6

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 6 AE: backache.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 7 Severe PDPH by gauge.
Figuras y tablas -
Analysis 3.7

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 7 Severe PDPH by gauge.

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 8 Any headache by gauge.
Figuras y tablas -
Analysis 3.8

Comparison 3 Larger gauge atraumatic needles versus smaller gauge atraumatic needles, Outcome 8 Any headache by gauge.

Summary of findings for the main comparison. Traumatic needles compared to atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Traumatic needles compared to atraumatic needles for prevention of PDPH

Patient or population: patients undergoing lumbar punctures
Settings: all settings (countries: Argentina, Austria, Brazil, Canada, Denmark, Finland, France, Germany, India, Israel, Italy, Korea, Mexico, Nepal, Netherlands, Nigeria, Norway, Pakistan, Spain, Thailand, UK and USA)
Intervention: traumatic needles (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon)
Comparison: atraumatic needles (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Atraumatic needles

Traumatic needles

Onset of PDPH

30 per 1000

64 per 1000
(52 to 80)

RR 2.14
(1.72 to 2.67)

9378
(36 studies)

⊕⊕⊕⊝
moderate1

Adverse events: paraesthesia

52 per 1000

50 per 1000
(25 to 102)

RR 0.96
(0.47 to 1.96)

573
(3 studies)

⊕⊕⊕⊝
moderate1

Adverse events: backache

155 per 1000

147 per 1000
(118 to 183)

RR 0.94
(0.78 to 1.13)

3027
(12 studies)

⊕⊕⊕⊝
moderate1

Severe PDPH

0 per 1000

10 per 1000

RD 0
(0.00 to 0.01)

6420
(24 studies)

⊕⊕⊝⊝
low1,2

Any headache

221 per 1000

290 per 1000
(228 to 367)

RR 1.35
(1.17 to 1.57)

4104
(18 studies)

⊕⊕⊕⊝
moderate1

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues).
2Inconsistency downgraded by one level due to presence of considerable heterogeneity (I2 = 42%), caused by one study focused on diagnostic lumbar punctures (Muller 1994).

Figuras y tablas -
Summary of findings for the main comparison. Traumatic needles compared to atraumatic needles for prevention of post‐dural puncture headache (PDPH)
Summary of findings 2. Larger traumatic needles compared to smaller traumatic needles for prevention of post‐dural puncture headache (PDPH)

Traumatic needle(major gauge) compared to traumatic needle (minor gauge) for prevention of PDPH

Patient or population: patients undergoing lumbar punctures with traumatic needles (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon)
Settings: all settings (countries: Finland, Germany, India, Italy, Korea, Pakistan and USA)
Intervention: traumatic needle ‐ larger gauge (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon)
Comparison: traumatic needle ‐ smaller gauge (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Traumatic needle ‐ smaller gauge

Traumatic needle ‐ larger gauge

Onset of PDPH

RR ranged

from 0.86 to 6.47

2288
(10 studies)

⊕⊕⊝⊝
low1,3

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.

Adverse events: paraesthesia ‐ not reported

See comment

See comment

Not estimable

See comment

We did not identify any studies reporting this outcome.

Adverse event: backache

RR ranged
from 0.81 to 2.00

948
(3 studies)

⊕⊕⊕⊝
moderate1

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.

Severe PDPH

RD ranged
from 0.00 to 0.00

1128
(6 studies)

⊕⊕⊝⊝
low1,2

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.

Any headache

RR ranged
from 0.75 to 1.56

771
(3 studies)

⊕⊕⊕⊝
moderate1

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in another.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues).

2Imprecision downgraded by one level due to few events reported in each arm.

3Imprecision downgraded by one level due unclear clinical decisions indicated by each confidence interval limit.

Figuras y tablas -
Summary of findings 2. Larger traumatic needles compared to smaller traumatic needles for prevention of post‐dural puncture headache (PDPH)
Summary of findings 3. Larger atraumatic needles compared to smaller atraumatic needles for prevention of post‐dural puncture headache (PDPH)

Atraumatic needle (major gauge) compared to atraumatic needle (minor gauge) for prevention of PDPH

Patient or population: patients undergoing lumbar punctures with atraumatic needles (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)
Settings: all settings (countries: Canada, France, India, Italy, Spain, UK and USA)
Intervention: atraumatic needle ‐ larger gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)
Comparison: atraumatic needle ‐ smaller gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor)

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Atraumatic needle ‐ smaller gauge

Atraumatic needle ‐ larger gauge

Onset of PDPH

RR ranged from 0.38 to 9.3

3134
(13 studies)

⊕⊕⊝⊝
low1,2

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.

Adverse events: paraesthesia

RR ranged from 1.03 to 7.61

439
(2 studies)

⊕⊕⊕⊝
moderate1

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.

Adverse events: backache

RR ranged
from 0.95 to 5.00

526
(4 studies)

⊕⊕⊕⊝
moderate1

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.

Severe PDPH

RD ranged
from 0 to 0.01

1983
(8 studies)

⊕⊕⊝⊝
low1,2

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.

Any headache

RR ranged
from 1.13 to 2.17

1791
(7 studies)

⊕⊕⊕⊝
moderate1

We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues).
2Imprecision downgraded by one level due unclear clinical decisions indicated by each confidence interval limit.

Figuras y tablas -
Summary of findings 3. Larger atraumatic needles compared to smaller atraumatic needles for prevention of post‐dural puncture headache (PDPH)
Comparison 1. Traumatic needle versus atraumatic needle

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 PDPH by indication Show forest plot

36

9378

Risk Ratio (M‐H, Random, 95% CI)

2.14 [1.72, 2.67]

1.1 Anaesthesia only

30

8401

Risk Ratio (M‐H, Random, 95% CI)

2.21 [1.60, 3.04]

1.2 Myelography only

3

548

Risk Ratio (M‐H, Random, 95% CI)

2.01 [1.34, 3.00]

1.3 Diagnostic lumbar puncture only

3

429

Risk Ratio (M‐H, Random, 95% CI)

2.22 [1.38, 3.58]

2 PDPH by gauge Show forest plot

20

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 22 gauge

5

877

Risk Ratio (M‐H, Random, 95% CI)

2.15 [1.56, 2.97]

2.2 25 gauge

5

1260

Risk Ratio (M‐H, Random, 95% CI)

2.48 [1.56, 3.95]

2.3 27 gauge

11

4076

Risk Ratio (M‐H, Random, 95% CI)

2.87 [1.81, 4.53]

3 PDPH by gender Show forest plot

9

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 Only women

9

1424

Risk Ratio (M‐H, Random, 95% CI)

2.60 [1.62, 4.17]

4 PDPH/anaesthesia: type of surgery Show forest plot

30

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 Caesarean section

8

1324

Risk Ratio (M‐H, Random, 95% CI)

3.12 [1.60, 6.10]

4.2 Orthopaedic procedures

3

994

Risk Ratio (M‐H, Random, 95% CI)

1.35 [0.58, 3.19]

4.3 Other surgeries

19

6083

Risk Ratio (M‐H, Random, 95% CI)

2.30 [1.50, 3.51]

5 PDPH by position Show forest plot

20

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

5.1 Lateral position

9

3242

Risk Ratio (M‐H, Random, 95% CI)

4.70 [2.39, 9.24]

5.2 Sitting position

11

2193

Risk Ratio (M‐H, Random, 95% CI)

2.11 [1.52, 2.94]

6 PDPH by age Show forest plot

36

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

6.1 No distinctions by age

34

9063

Risk Ratio (M‐H, Random, 95% CI)

2.17 [1.73, 2.73]

6.2 Only < 18 years

2

315

Risk Ratio (M‐H, Random, 95% CI)

1.69 [0.56, 5.12]

7 AE: paraesthesia Show forest plot

3

573

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.47, 1.96]

8 AE: backache Show forest plot

12

3027

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.78, 1.13]

9 Severe PDPH by indication Show forest plot

24

6420

Risk Ratio (M‐H, Random, 95% CI)

1.88 [1.20, 2.94]

9.1 Anesthesia

19

5542

Risk Ratio (M‐H, Random, 95% CI)

1.77 [0.88, 3.53]

9.2 Myelography

4

778

Risk Ratio (M‐H, Random, 95% CI)

1.70 [0.68, 4.28]

9.3 Diagnostic lumbar puncture

1

100

Risk Ratio (M‐H, Random, 95% CI)

3.0 [1.18, 7.63]

10 Any headache by indication Show forest plot

18

4104

Risk Ratio (M‐H, Random, 95% CI)

1.35 [1.17, 1.57]

10.1 Anaesthesia

16

3656

Risk Ratio (M‐H, Random, 95% CI)

1.38 [1.17, 1.63]

10.2 Myelography

2

448

Risk Ratio (M‐H, Random, 95% CI)

1.34 [0.81, 2.21]

11 PDPH sensitivity analysis Show forest plot

3

802

Risk Ratio (M‐H, Random, 95% CI)

2.78 [1.26, 6.15]

Figuras y tablas -
Comparison 1. Traumatic needle versus atraumatic needle
Comparison 2. Larger gauge traumatic needles versus smaller gauge traumatic needles

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 PDPH larger gauge vs smaller gauge Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 23 G vs 25 G

1

53

Risk Ratio (M‐H, Random, 95% CI)

2.08 [0.20, 21.55]

1.2 25 G vs 27 G

4

1041

Risk Ratio (M‐H, Random, 95% CI)

1.82 [0.98, 3.39]

1.3 25 G vs 29 G

3

376

Risk Ratio (M‐H, Random, 95% CI)

2.13 [0.46, 9.78]

1.4 26 G vs 27 G

1

658

Risk Ratio (M‐H, Random, 95% CI)

6.47 [2.55, 16.43]

1.5 21 G vs 25 G

1

160

Risk Ratio (M‐H, Random, 95% CI)

0.86 [0.30, 2.44]

2 PDPH by type of surgery Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 Caesarean section

2

455

Risk Ratio (M‐H, Random, 95% CI)

1.28 [0.64, 2.57]

2.2 Orthopaedic surgeries

2

213

Risk Ratio (M‐H, Random, 95% CI)

0.99 [0.38, 2.58]

2.3 Other surgeries

6

1620

Risk Ratio (M‐H, Random, 95% CI)

2.94 [1.23, 7.03]

3 PDPH by age Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 No distinctions about age

8

2175

Risk Ratio (M‐H, Random, 95% CI)

2.09 [1.11, 3.95]

3.2 Only children

1

60

Risk Ratio (M‐H, Random, 95% CI)

3.0 [0.13, 70.83]

3.3 Only > 60 years

1

53

Risk Ratio (M‐H, Random, 95% CI)

2.08 [0.20, 21.55]

4 PDPH by position Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 Lateral position

5

859

Risk Ratio (M‐H, Random, 95% CI)

1.76 [0.98, 3.16]

4.2 Sitting position

2

584

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.64, 1.56]

5 AE: backache Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

6 Severe PDPH by gauge Show forest plot

6

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

6.1 23 G vs 25 G

1

53

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.07, 0.07]

6.2 25 G vs 27 G

3

815

Risk Difference (M‐H, Random, 95% CI)

0.00 [‐0.01, 0.01]

6.3 25 G vs 29 G

1

100

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.04, 0.04]

6.4 21 G vs 25 G

1

160

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

7 Any headache Show forest plot

3

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Figuras y tablas -
Comparison 2. Larger gauge traumatic needles versus smaller gauge traumatic needles
Comparison 3. Larger gauge atraumatic needles versus smaller gauge atraumatic needles

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 PDPH larger gauge vs smaller gauge Show forest plot

13

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 22 G vs 24 G

1

375

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.20, 4.81]

1.2 22 G vs 25 G

2

334

Risk Ratio (M‐H, Random, 95% CI)

3.00 [0.32, 28.50]

1.3 24 G vs 25 G

2

647

Risk Ratio (M‐H, Random, 95% CI)

5.62 [1.00, 31.67]

1.4 25 G vs 26 G

3

519

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.30, 1.90]

1.5 25 G vs 27 G

2

612

Risk Ratio (M‐H, Random, 95% CI)

3.72 [0.59, 23.64]

1.6 26 G vs 27 G

2

258

Risk Ratio (M‐H, Random, 95% CI)

1.79 [0.30, 10.73]

1.7 27 G vs 29 G

1

389

Risk Ratio (M‐H, Random, 95% CI)

1.59 [0.58, 4.37]

2 PDPH by type of surgery Show forest plot

13

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 Caesarean section

6

1263

Risk Ratio (M‐H, Random, 95% CI)

1.92 [0.64, 5.79]

2.2 Orthopaedic procedures

2

392

Risk Ratio (M‐H, Random, 95% CI)

1.24 [0.30, 5.07]

2.3 Other surgeries

5

1479

Risk Ratio (M‐H, Random, 95% CI)

1.44 [0.73, 2.83]

3 PDPH by gender Show forest plot

8

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

3.1 Only women

8

1853

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.51, 2.20]

4 PDPH by position Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 Sitting position

5

1106

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.45, 2.06]

4.2 Lateral position

5

992

Risk Ratio (M‐H, Random, 95% CI)

1.88 [0.65, 5.41]

5 AE: paraesthesia Show forest plot

2

439

Risk Ratio (M‐H, Random, 95% CI)

2.19 [0.31, 15.30]

6 AE: backache Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

7 Severe PDPH by gauge Show forest plot

8

Risk Difference (M‐H, Random, 95% CI)

Subtotals only

7.1 22 G vs 24 G

1

375

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

7.2 22 G vs 25 G

1

234

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

7.3 24 G vs 25 G

1

304

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.03]

7.4 25 G vs 26 G

2

311

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.01, 0.03]

7.5 25 G vs 27 G

1

212

Risk Difference (M‐H, Random, 95% CI)

0.01 [‐0.02, 0.04]

7.6 26 G vs 27 G

1

158

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.02, 0.02]

7.7 27 G vs 29 G

1

389

Risk Difference (M‐H, Random, 95% CI)

0.0 [‐0.01, 0.01]

8 Any headache by gauge Show forest plot

7

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

8.1 22 G vs 25 G

1

234

Risk Ratio (M‐H, Random, 95% CI)

2.17 [0.85, 5.51]

8.2 24 G vs 25 G

2

645

Risk Ratio (M‐H, Random, 95% CI)

1.17 [0.49, 2.77]

8.3 25 G vs 26 G

2

311

Risk Ratio (M‐H, Random, 95% CI)

1.13 [0.65, 1.99]

8.4 25 G vs 27 G

1

212

Risk Ratio (M‐H, Random, 95% CI)

1.87 [0.65, 5.39]

8.5 27 G vs 29 G

1

389

Risk Ratio (M‐H, Random, 95% CI)

1.80 [0.85, 3.83]

Figuras y tablas -
Comparison 3. Larger gauge atraumatic needles versus smaller gauge atraumatic needles