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

Flaatten 2000.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Norway

  • Multisite: no

  • Needle tip used: pencil vs diamond

  • Needle diameter used: 27 G

  • Number of attempts (mean): 1.09 vs 1.27

  • Procedure: spinal or epidural anaesthesia

  • Site of the puncture: unknown

  • Training level of those who administered the puncture: consultant anaesthesiologist

  • Median or paramedian technique: unknown

  • Type of anaesthetic: not standardized

  • Patient position: sitting or lateral supine position
Participants 1. 313 patients aged 18 to 55 years were enrolled (scheduled for non‐obstetric outpatient surgery below the umbilicus to be performed during spinal anaesthesia)
Exclusion criteria: unclear
Patients randomized to:

  • 27 G Pencan group:158 (50.4%)

  • 27 G Quincke group: 155 (49.5%)


2. 12 patients were excluded from analysis

  • No CSF found: 2

  • Too old: 2

  • Drunk during follow‐up: 1

  • Lost to follow‐up: 7


3. 301 patients were analysed (lost to follow‐up: 3.83%)

  • 27 G Pencan group: 153

  • 27 G Quincke group: 148


3. Main characteristics of patients:

  • Age (mean, SD): 27 G Pencan: 37.2, 9.8; 27 G Quincke: 37.8, 10.7

  • Gender ‐ male (number): 27 G Pencan: 101; 27 G Quincke: 90

  • Arthroscopy (number, %): 27 G Pencan: 94, 63.5%; 27 G Quincke: 103, 67.3%
Interventions 1. 27 G Pencan group: 0.40 mm O.D. B Braun, Germany
2. 27 G Quincke group: Spinocan 27 G, B. Braun, Germany. The bevel of the Quincke‐type spinal needle was kept parallel to the longitudinal direction of the dural sac.
Outcomes Outcomes were not classified as primary or secondary

  1. Postoperative backache

  2. Headache

  3. PDPH

  4. Duration of headache (days)

  5. Intensity scale (NRS)
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: 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: "Randomisation was performed using the sealed envelope technique.…" (page 643)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "Randomisation was performed using the sealed envelope technique.…" (page 643)
Blinding of participants (performance bias) Low risk Quote: "All patients were blinded to the choice of spinal needle, and only the needle size of the spinal needle was documented in the anaesthetic record." (page 644)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "All patients were followed up by a single anaesthesiologist (HF) also blinded to the choice of spinal needle." (page 644)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3.83% 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