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

Rasmussen 1989a.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Denmark

  • Multisite: no

  • Needle tip used: unclear vs pencil

  • Needle diameter used: 20 vs 25

  • Number of attempts: unknown

  • Procedure: anaesthesia

  • Site of the puncture: L3‐4

  • Training level of those who administered the puncture: anaesthetists

  • Median or paramedian technique: midline approach

  • Type of anaesthetic: 0.5% bupivacaine

  • Patient position: lateral position
Participants 1. 200 admitted for elective total unilateral hip replacement were enrolled
Number of patients randomized per arm: unclear
2. 17 patients (8.5%) were excluded from analysis, in the pre and postoperative period. It was impossible to perform the spinal procedure with the prescribed 25 G needle in 4 patients; 7 had an incomplete block, of whom 5 had a supplementary general anaesthetic and 2 another spinal injection; 4 had major cardiovascular complications, 1 had a classical migraine first noticed postoperatively and another needed a further spinal anaesthetic on the second postoperative day because the artificial hip dislocated.
183 patients were analysed:

  • 20 G Mediplast group: 93 patients

  • 25 G Vygon group: 90 patients


3. Main characteristics of patients:

  • Age (mean, range): 20 G Mediplast group: 68.8, 45 to 88; 25 G Vygon group: 69.1, 21 to 82

  • Gender ‐ male (number): 20 G Mediplast group: 43; 25 G Vygon group: 44
Interventions

  1. 20 G Mediplast. No further details are provided.

  2. 25 G Vygon. No further details are provided.
Outcomes Outcomes were not classified as primary or secondary

  1. Headache/PDPH ‐ no PDPH
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: "The patients were randomly allocated in a double blind manner (..)" (page 184)
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: "The authors as well as the patients were blinded with respect to needle size" (page 571)
"Spinal anaesthesia was performed by the department anaesthetists, but did not include the authors." (page 571)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The authors as well as the patients were blinded with respect to needle size" (page 571)
"The patients in study 1 were interviewed by one of the authors on the fourth day after surgery (...)" (page 571)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 8.5% of 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