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

Lavi 2006.

Methods

  • Design: parallel‐group (2 arms), prospective, randomized trial

  • Country: Israel

  • Multisite: no

  • International: no

  • Needle type design used: 22 G Quincke traumatic needle, 22 G Whitacre atraumatic needle

  • Needle diameter used: 22 G

  • Procedure: lumbar puncture

  • Patient position: patients were lying on their side and received local anaesthesia prior to the procedure
Participants 1. 63 patients enrolled (consecutive patients older than 18 years scheduled for a diagnostic or therapeutic lumbar puncture as a part of their routine clinical management)

    • 58 patients randomized to:

      • 22 G Quincke traumatic (N = 29)

      • 22 G Whitacre atraumatic (N = 29)


2. 5 patients randomized were excluded due to:

      • Low platelet count

      • Abnormal brain CT scan

      • History of recent lumbar puncture


3. 0 patients lost to follow‐up
4. Main characteristics of patients:

    • Mean age

      • 22 G Quincke traumatic: 49 years

      • 22 G Whitacre atraumatic: 42 years

    • Number (%) of women:

      • 22 G Quincke traumatic: 17 (59)

      • 22 G Whitacre atraumatic: 16 (55)

    • Percentage/number of postures during the lumbar puncture: lying on side, directed parallel to patient's axis

    • Other characteristics: PDPH was more prevalent in patients with lower BMI (< 20, 37.5%; BMI 20 to 30, 13.5%)
Interventions

  1. Quincke traumatic group: 22 G, 90 mm, TSK Japan

  2. Whitacre atraumatic group: 22 G, 0.70 mm, 103 mm, Polymedic, E.C. Japan
Outcomes Outcomes were not classified as primary or secondary
A. Incidence of PDPH
B. Adverse events: not reported
C. Severity PDPH
D. Any headache subsequent to a lumbar puncture: not reported
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: July to December 2004

  6. Declared conflicts of interest: no (page 1492)
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 randomly assigned to undergo LP with a standard (...).Patients were randomized only once. Therefore, those who required repeated LPs had them done with the same needle type." (page 1492)
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 study was blinded to the patient. However, because the different needles have different structures, the physician knew which needle was used and could not be blinded to the needle." (page 1492)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Follow‐up was performed by a physician, blinded to the randomization, on days 2 (...)". (page 1492)
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