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

Geurts 1990.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Netherlands

  • Multisite: no

  • Needle tip used: unknown

  • Needle diameter used: 25 vs 29

  • Number of attempts: unknown

  • Procedure: anaesthesia

  • Site of the puncture: L 3‐4 or L 4‐5

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

  • Median or paramedian technique: unknown

  • Type of anaesthetic: 2.5 ml to 4.0 ml of hyperbaric bupivacaine 0.5%

  • Patient position: lateral position
Participants 1. 40 patients healthy ASA I patients under 40 years of age were enrolled. Indications for surgery varied, but all operations were subumbilical.
Exclusion criteria: patients complaining of pre‐existing headache or backache
Patients randomized to:

  • 25 G group: 40 patients (50%)

  • 29 G group: 40 patients (50%)


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

  • Age (mean, SD): 25 G group: 27.1, 5.9; 29 G group: 27.9, 7

  • Gender ‐ male (number): 25 G group: 31; 29 G group: 23

  • Lumbar myelography (number): 21 G Sprotte group: 110; 22 G Quincke group: 120

  • Arthroscopy and surgery of the knee (number): 21 G Sprotte group: 19; 22 G Quincke group: 13
Interventions

  1. 25 G group: the bevel of the needle was kept parallel to the dural fibres

  2. 29 G group: no attention was paid to the direction of the bevel
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Atypical headache

  3. Backache

  4. Differences in mean block height

  5. Volumes of bupivacaine used
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: "a restricted randomised double‐blind study to ensure equal numbers in each group was initiated…" (page 350).
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. Quote: "The use of a 0.90 mm introducer needle ensured that the patients were unable to differentiate between the two spinal needles." (page 350)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Postoperatively, patients were visited by two of the authors (MCH and RMW), who had no knowledge of which needle size had been used for spinal anaesthesia." (page 350)
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