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

Muller 1994.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Germany

  • Multisite: no

  • Needle tip used: 22 G Sprotte vs 20 G Quincke

  • Needle diameter used: 22 vs 20

  • Number of attempts (2 or more): 32 patients

  • Procedure: diagnostic LP

  • Site of the puncture: unknown

  • Training level of those who administered the puncture: resident

  • Median or paramedian technique: unknown

  • Amount of CSF extracted: 10 ml to 20 ml

  • Amount of injected volume: unclear

  • Patient position: sitting
Participants 1. 100 consecutive patients undergoing diagnostic LP were enrolled
Exclusion criteria: contraindications against any type of LP
Patients randomized to:

  • 22 G Sprotte group: 50 (50%)

  • 20 G Quincke group: 50 (50%)


2. 10 patients (10%) were excluded from analysis, due to protocol deviations
Patients analysed:

  • 22 G Sprotte group: 48

  • 20 G Quincke group: 42


3. Main characteristics of patients (only analysed patients):

  • Age (mean, SD): 22 G Sprotte group: 46, 16; 20 G Quincke group: 44, 16

  • Height (mean, SD): 22 G Sprotte group: 167, 8; 20 G Quincke group: 170, 9

  • Weight (mean, SD): 22 G Sprotte group: 69, 13; 20 G Quincke group: 73, 14

  • Gender ‐ male (number): 22 G Sprotte Group: 21; 20 G Quincke Group: 25
Interventions

  1. Sprotte G 22: (Pajunk GmbH, Feinwerk‐Medizintechnologie, Geisingen, Germany). The atraumatic cannula was used by an introducer 18 G.

  2. Quincke 20 G. Unclear if an introducer was used.

  3. Co‐intervention: after LP all patients were told to lie flat in bed for 6 hours, the first 30 minutes in the abdominal position, and to drink amply (1 L mineral water or tea)
Outcomes Outcomes were not classified as primary or secondary

  1. Post‐puncture complaints

  2. PDPH

  3. Severity of PDPH
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: "The study was carried out as a prospective randomized blind study on a general neurological ward (..)" (page 376)
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 LP was carried out by a resident who was asked not to disclose the type of needle to the patient or to the masked examiner." (page 377)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "All examinations were carried out by an examiner who was unaware of the puncture technique and observations were recorded on standardised check‐lists (…)" (page 377)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 10% of 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