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

Mayer 1992.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Canada

  • Multisite: yes (2 sites)

  • Needle type design used: 27 G Quincke vs 24 G Sprotte

  • Needle diameter used: 27 vs 24

  • Procedure: spinal anaesthesia

  • Number of attempts: 1.7 vs 1.6

  • Site of the puncture: L2‐3, L3‐4

  • Training level of those who administered the puncture: staff, fellows and residents under supervision

  • Median or paramedian technique: unknown

  • Type of anaesthetic: hyperbaric 0.75% bupivacaine with 8.25% dextrose or preservative‐free morphine (0.2 mg) was added to the syringe containing bupivacaine

  • Patient position: sitting or lateral position
Participants 1. 298 patients enrolled (patients consenting to spinal anaesthesia for elective and emergency caesarean section)

    • Patients randomized to:

      • 27 G Quincke group: (147, 49.3%)

      • 24 G Sprotte group: (151, 50.7%)


3. Losses to follow‐up or exclusions: not reported
2. Main characteristics of patients:

  • Age (mean, SD): 27 G Quincke group: 30.3, 5; 24 G Sprotte group: 30.5, 4.5

  • Height (mean, SD): 27 G Quincke group: 160.8, 6.1; 24 G Sprotte group: 161.9, 6.5

  • Weight (mean, SD): 27 G Quincke group: 73.7, 10.7; 24 G Sprotte group: 75.1, 12.9
Interventions

  1. Quincke group: 27 G needle, Becton‐Dickinson, Rutherford, NJ

  2. Sprotte group: 24 G needle, Pajunk, Geisingen, Germany

  3. Co‐intervention: an introducer was used in all patients
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Number of attempts at puncture

  3. Adverse events (paraesthesias)

  4. Severity of PDPH

  5. Headache different from PDPH
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: "The needle to be used was assigned in a random manner: (…)". (page 58)
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
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
Selective reporting (reporting bias) Low risk All patient‐important outcomes were reported
Other bias Low risk No other biases were identified