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. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

Rafique 2014.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Pakistan

  • Needle tip used: diamond

  • Needle diameter used: 25 G vs 27 G

  • Number of attempts: 1

  • Procedure: anaesthesia

  • Site of the puncture: site/unclear

  • Training level of those who administered the puncture: attending anaesthesiologist

  • Median or paramedian technique: unclear

  • Type of anaesthetic: unclear

  • Patient position: sitting or lateral supine position
Participants 1. 90 patients enrolled (female patients of 20 to 38 years old, undergoing caesarian sections)
Exclusion criteria: ASA above III
Number of patients randomized per arm: unclear
2.Number of patients excluded (who required more than one prick): unclear. 3 patients were excluded from analysis for unknown reasons.
Number of analysed patients:

  • Group I (25 G Quincke spinal needle): 44 (48%)

  • Group II (27 G Quincke spinal needle): 43 (47%)


3. No patients lost to follow‐up
4. Main characteristics of patients:

  • Age (mean, SD): group 1: 28 ± 4.5/group 2: 27 ± 3.1
Interventions

  1. Group 1: spinal anaesthesia with 25 G Quincke spinal needle

  2. Group 2: spinal anaesthesia with 27 G Quincke spinal needle
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Patient satisfaction

  3. Severity of headache
Notes

  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: no

  5. Conducted: not stated

  6. Declared conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "ninety female patients of 20 to 38 years of age, undergoing caesarian sections were randomly distributed to either 25 or 27 gauge Quincke needle groups" (page 1)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "The patients were interviewed first through third post‐operative days about the occurrence of headache and their satisfaction regarding spinal anesthesia." (page 1)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
Selective reporting (reporting bias) High risk Adverse events, additional to PDPH, were not reported
Other bias Low risk No other biases were identified