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

Shah 2010.

Methods

  • Design: parallel‐group (2 arms)

  • Country: India

  • Multisite: no

  • International: no

  • Needle type design used: Quincke vs Whitacre

  • Needle diameter used: 25 vs 27

  • Procedure: subarachnoid anaesthesia

  • Number of attempts (1 attempt): 92% to 61%

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

  • Training level of those who administered the puncture: experienced anaesthesiologists

  • Median or paramedian technique: midline approach

  • Type of anaesthesia: 12.5 mg to 17.5 mg bupivacaine

  • Patient position: lateral position
Participants 1. 800 young patients (16 to 40 years old) with ASA risk I/II scheduled for endoscopic urological procedures under spinal anaesthesia between January 2008 and December 2009 were enrolled in this study
Exclusion criteria: history of headache, use of oral opioids or non‐steroidal anti‐inflammatory drugs, or contraindications to spinal anaesthesia
Patients randomized to:

  • 25 G Quincke group: 200 patients (25%)

  • 27 G Quincke group: 200 patients (25%)

  • 25 G Whitacre group: 200 patients (25%)

  • 27 G Whitacre group: 200 patients (25%)


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

  • Age (mean, SD): 25 G Quincke group: 30, 8.2; 27 G Quincke group: 27.8, 9.4; 25 G Whitacre group: 29, 7.7; 27 G Whitacre group: 28.31, 8.8

  • Weight (mean, SD): 25 G Quincke group: 59.3, 14.8; 27 G Quincke group: 57.3, 11.6; 25 G Whitacre group: 56.5, 13.3; 27 G Whitacre group: 59.5, 11.8
Interventions

  • Quincke 25 G (0.50 x 90 mm) Becton Dickinson (Madrid, Spain)

  • Quincke 27 G (0.40 x 90 mm) Becton Dickinson (Madrid, Spain)

  • Whitacre pencil point 25 G (0.50 x 90 mm) Becton Dickinson (Madrid, Spain)

  • Whitacre 27 G (0.40 x 90 mm) Becton Dickinson (Madrid, Spain)
Outcomes Outcomes were not classified as primary or secondary

  1. Headache (PDPH)

  2. 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: yes

  5. Conducted: January 2008 and December 2009

  6. Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly divided by computer‐generated random numbers into four groups of 200 patients each." (page 25)
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: "Postoperatively, all patients were visited successively for three days by a staff member, who was unaware of the type of needle used, to inquire about headache." (page 25)
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