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

Pittoni 1995.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Italy

  • Multisite: no

  • Needle tip used: 22 G Sprotte vs 25 G Sprotte

  • Needle diameter used: 22 vs 25

  • Number of attempts: 1 to 5 attempts

  • Procedure: anaesthesia

  • Site of the puncture: L2‐3 or L3‐4

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

  • Median or paramedian technique: median

  • Type of anaesthesia: bupivacaine 1% in glucose 8%

  • Patient position: lateral position
Participants 1. 234 ASA I‐II outpatients undergoing elective arthroscopy of the knee joint
Exclusion criteria: contraindication to regional anaesthesia
Patients randomized to:

  • 22 G Sprotte group: 117 patients (50%)

  • 25 G Sprotte group: 117 patients (50%)


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

  • Age (mean, SD): 22 G Sprotte group: 39, 15; 25 G Sprotte group: 37, 15

  • Height (mean, SD): 22 G Sprotte group: 171, 7; 25 G Sprotte group: 171, 9

  • Weight (mean, SD): 22 G Sprotte group: 75, 13; 25 G Sprotte group: 73, 12

  • Gender ‐ male (number): 22 G Sprotte group: 86; 25 G Sprotte group: 78
Interventions

  1. 22 G (0.7 mm) Sprotte needle (Pajunk, Geisingen, Germany)

  2. 25 G (0.7 mm) Sprotte needle (Pajunk, Geisingen, Germany). A 21 G introducer was used.
Outcomes Outcomes were not classified as primary or secondary

  1. Headache/PDPH ‐ backache

  2. Duration of PDPH

  3. Presence of associated symptoms

  4. Severity of PDPH

  5. Number of attempts

  6. Failed spinal anaesthesia
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: "Patients were allocated randomly to receive (…)" (page 73)
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
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "and were interviewed by one of the authors (blind with respect to needle size(…)" (page 74)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost to follow‐up
Selective reporting (reporting bias) Low risk All patient‐important outcomes were reported
Other bias Low risk No other biases were identified