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

Tourtellotte 1972.

Methods

  • Design: parallel‐group (2 arms)

  • Country: USA

  • Multisite: no

  • International: no

  • Needle tip used: 22 G vs 26 G needles

  • Needle diameter used: 22 G vs 26 G needles

  • Number of attempts: unclear

  • Procedure: diagnostic lumbar puncture

  • Site of the puncture: unclear

  • Training level of those who administered the puncture: unclear

  • Median or paramedian technique: unclear

  • Amount of CSF extracted: 20 ml

  • Amount of injected volume: unclear

  • Type of anaesthetic: unclear

  • Patient position: left lateral position
Participants 1. 100 patients enrolled (healthy volunteers rated normal on physical and neurological examinations)

    • 100 patients randomized to:

      • 22 G needle group (50, 50%)

      • 26 G needle group (50, 50%)


2. No randomized patients were excluded from the study

    • No patients lost to follow‐up


3. Main characteristics of patients:

    • Age: 22 G needle group and 26 G needle group: 23.2 years with a range of 20 to 41

    • Gender: 22 G needle group: 46% female/54% male

    • 26 G needle group: 34% female/66% male
Interventions

  1. 22 G needle group

  2. 26 G needle group
Outcomes Outcomes were not classified as primary or secondary

  1. Post‐lumbar puncture complaints

  2. Post‐lumbar puncture complaints: minor complaints: headaches for only a short period immediately after the LP, minimal to mild, non‐postural headaches, unusual tiredness on the day of the LP, slight numbness and insomnia

  3. Post‐lumbar puncture complaints: major complaints: mild to severe postural headaches that were often incapacitating and accompanied by other complaints such as backaches, unusual tiredness, anorexia, nausea and vomiting, and weight loss

  4. Presence of postural headaches
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: no
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: "Members of each successive pair of incoming volunteers were randomly" (page 1)
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 subjects were blinded with respect to size of needle used. They were all interviewed by the same neurologist (W.W.T.), who was also blinded as to needle size" (page 2)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "They were all interviewed by the same neurologist (W.W.T.), who was also blinded as to needle size" (page 2)
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