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

Brattebo 1995.

Methods

  • Design: parallel‐group, 2 arms

  • Country: Norway

  • Multisite: no

  • Needle tip used: atraumatic vs traumatic

  • Needle diameter used: 24 vs 27

  • Number of attempts (> 2) = 7% (95% CI 4 to 11)

  • Procedure: anaesthesia

  • Site of the puncture: L2 to L5

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: unknown

  • Type of anaesthetic: lidocaine or bupivacaine

  • Patient position: sitting or lateral supine position
Participants 1. 200 patients enrolled (patients scheduled for surgery in the lower part of the body)

  • Patients randomized to:

    • Quincke 27 G (100, 50%)

    • Sprotte 24 G (100, 50%)


2. 2 patients randomized to Quincke group were excluded due to failures in identification of subarachnoidal space
3. No patients lost to follow‐up
4. Main characteristics of patients:

  • Gender ‐ male (number): Quincke group: 52; Sprotte group: 49

  • Age (mean, SD): Quincke group: 29.6, 7.5; Sprotte group: 29, 7.8

  • Position‐ lateral supine (number): Quincke group: 93; Sprotte group: 94

  • Site of the puncture L3‐4 (number): Quincke group: 75; Sprotte group: 75

  • Number of attempts at dural puncture > 2: Quincke group: 9; Sprotte group: 4
Interventions

  1. Quincke 27 G = disposable 27 G Quincke bevelled needle (Becton Dickinson Yale). The bevel was kept parallel to the spine.

  2. Sprotte 24 G = 24 G needle (Pajunk)

  3. Co‐interventions: most patients received midazolam 1 mg to 5 mg as premedication
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH: defined as a position dependent headache limiting daily activities

  2. Severe PDPH: need for an epidural blood patch

  3. Technical ease of the needle insertion: described on an arbitrary 3‐point scale, from easy to difficult

  4. Back pain

  5. Non‐specific headache

  6. Number of puncture attempts

  7. Spread of anaesthesia: adequate or insufficient
Notes

  1. Trial registration: not stated

  2. Funder: Medisinsk forskning I Finnmark

  3. Role of funder: financial support

  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 Quote: "… were randomised into two groups after written informed consent was obtained" (page 535)
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 patients did not know which needle was used"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "After 72 hours all patient were contacted personally or by telephone, and questioned in a structured interview about problems or symptoms which could have been a result of the spinal anaesthetic. This interview was done by a nurse anaesthetist who was unaware of which needle that had been used, and whether any problems had occurred during the anaesthetic." (page 536)
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 Unclear risk The role of the funder during the study was unclear (Medisinsk forskning I Finnmark)