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

Kang 1992.

Methods

  • Design: parallel‐group (2 arms)

  • Country: USA

  • Multisite: no

  • Needle tip used: 26 G Quincke vs 27 G Quincke

  • Needle diameter used: 26 vs 27

  • Number of attempts: unknown

  • Procedure: anaesthesia

  • Site of the puncture: L3‐4, L4‐5 or L5‐S1

  • Training level of those who administered the puncture: investigators

  • Median or paramedian technique: midline approach

  • Type of anaesthetic: lidocaine 5% with glucose 7.5% or bupivacaine 0.75% in dextrose 8.25%

  • Patient position: unknown
Participants 1. 730 ambulatory surgery patients, 18 years or older, ASA I or II, and electing to receive spinal anaesthesia, were enrolled
Exclusion criteria: patients with history of migraine headache or chronic back pain
Number of patients randomized to each group: unclear
2. 72 patients (9.86%) were excluded at follow‐up
Patients analysed:

  • 26 G Quincke group: 322

  • 27 G Quincke group: 336


3. Main characteristics of patients:

  • Age (mean, SD): 26 G Quincke group: 38.3, 16; 27 G Quincke group: 38.6, 16.9

  • Height (mean, SD): 26 G Quincke group: 170.5, 9.5; 27 G Quincke group: 170.2, 9.7

  • Weight (mean, SD): 26 G Quincke group: 77.6, 15.7; 27 G Quincke group: 77, 15.8

  • Gender ‐ male (number): 26 G Quincke group: 158; 27 G Quincke group: 162

  • Procedures/knee and ankle arthroscopy (number): 26 G Quincke group: 234; 27 G Quincke group: 237
Interventions

  1. 26 G Quincke (Becton‐Dickinson, Rutherford, NJ), with the bevel entering the dura parallel to the longitudinal axis of the spinal cord

  2. 27 G Quincke (Becton‐Dickinson, Rutherford, NJ), with the bevel entering the dura parallel to the longitudinal axis of the spinal cord
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Duration of PDPH

  3. Back pain

  4. Satisfaction with spinal anaesthesia

  5. Willingness to it again in the future for a similar surgery
Notes

  1. Trial registration: not stated

  2. Funder: Gundersen Medical Foundation

  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: "were randomly assigned (…)". (page 734)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Low risk Quote: "In operating room, while patients were blinded to the needle size used (…)". (page 380)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "One of the nurse investigators (..), who had no knowledge of the patient´s needle assignment, made (…)" (page 1007)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 9.86% of patients were lost to follow‐up
Selective reporting (reporting bias) High risk Severity of headache and back pain are mentioned, but results are not reported. Adverse events, additional to PDPH, were not reported.
Other bias Unclear risk The role of the funder in this research is unclear