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

Zela 1994.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Mexico

  • Multisite: no

  • International: no

  • Needle type design used: Whitacre vs Quincke

  • Needle diameter used: 25

  • Procedure: spinal anaesthesia

  • Number of attempts (1 attempt): unknown

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

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: midline approach

  • Type of anaesthesia: unclear

  • Patient position: unknown
Participants 1. 40 patients ASA I‐II, aged from 18 to 50 years, undergoing subumbilical surgery were enrolled
Exclusion criteria: history of headache, refusal of method, hypertension
Patients randomized to:

  • 25 G Whitacre Group: 20 patients (50%)

  • 25 G Quincke Group: 20 patients (50%)


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

  • Age (mean, SD): 25 G Whitacre group: 27, 18; 25 G Quincke group: 29, 17

  • Men (number): 24 G Sprotte group: 10; 27 G Quincke group: 10
Interventions

  • 25 G Whitacre needle: no details were provided

  • 25 G Quincke needle: no details were provided
Outcomes Outcomes were not classified as primary or secondary

  1. Headache (PDPH)

  2. Severity of headache
Notes

  1. Trial registration: not stated

  2. Funder: Becton Dickinson and Company

  3. Role of funder: provision of needles

  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: "(we) developed a clinical trial with 40 patients" (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 Low risk Quote: "Follow‐up to detect patients who developed PDPH was realized by an anesthesiologist different from the one who performed the procedure" (page 67)
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

Acronyms and abbreviations used in this table

ASA: American Society of Anesthesiologists; ASN: Atraucan spinal needle; BMI: body mass index; CI: confidence interval; c‐section: caesarean section; CSF: cerebrospinal fluid; G: gauge; IQR: interquartile range; L2‐3 to L3‐4: lumbar vertebrae 2‐3 to 3‐4; LP: lumbar puncture; NRS: numerical rating scale; NYHA: New York Heart Association; PDPH: post‐dural puncture headache; RCT: randomized controlled trial; SD: standard deviation; SEM: standard error of the mean; VAS: visual analogue scale; vs: versus; WSN: Whitacre spinal needle