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

Smith 1994.

Methods

  • Design: parallel‐group (2 arms)

  • Country: UK

  • Multisite: no

  • Needle tip used: atraumatic needles

  • Needle diameter used: 25 G Whitacre vs 27 G Whitacre

  • Number of attempts: unclear

  • Procedure: anaesthesia

  • Site of the puncture: L2‐3 or L3‐4

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: unknown

  • Type of anaesthesia: 0.5% bupivacaine

  • Patient position: lateral position
Participants 1. 212 women of ASA grade I undergoing spinal anaesthesia for elective caesarean section were enrolled
Patients randomized to:

  • 25 G Whitacre group: 104 patients (49.1%)

  • 27 G Whitacre group: 108 patients (50.9%)


2. No patients were excluded from further analysis
3. Main characteristics of patients:

  • Weight (mean, SD): 25 G Whitacre group: 66.4, 14.4; 27 G Whitacre group: 66.7, 14.9

  • Height (mean, SD): 25 G Whitacre group: 1.74, 0.15; 27 G Whitacre group: 1.60, 0.08
Interventions

  1. 25 G Whitacre group: no additional details provided

  2. 27 G Whitacre group: no additional details provided
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Backache

  3. Severity of PDPH

  4. Factors affecting easy of use
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 stated
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: "Patients were randomly allocated to receive a subarachnoid block using either a 25G or a 27G Whitacre (...)" (page 859)
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 Low risk Quote: "Patients were interviewed daily on the 1st to 5th postoperative days, by an anaesthetist unaware of the needle size used (..)". (page 860)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 8 patients (3.7%) were excluded from analysis
Selective reporting (reporting bias) Low risk All patient‐important outcomes were reported
Other bias Low risk No other biases were identified