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

Standl 2004.

Methods

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

  • Country: Germany

  • Multisite: yes (4 hospitals)

  • International: no

  • Needle type design used: hybrid vs pencil

  • Needle diameter used: 25 G

  • Procedure: spinal anaesthesia
Participants 1. 700 patients enrolled (ASA I/II/III patients were scheduled for lower abdominal or extremity surgery (orthopaedic, trauma, urology, visceral, gynaecology) and underwent the same protocol)
Patients randomized to:

  • 25 G Ballpen (339)

  • 25 G Sprotte (338)


23 randomized patients (15 group B, 18 group S) were excluded due to:

  • Missing data (23)


2. 0 patients lost to follow‐up
3. Main characteristics of patients:

  • Mean age (SD):

    • 25 G Ballpen 54 (18)

    • 25 G Sprotte 56 (17)

  • Number of females/males:

    • 25 G Ballpen 130/209

    • 25 G Sprotte 131/207

  • Number of postures during the lumbar puncture: lateral position (25 G Ballpen N = 3, 25 G Sprotte N = 4), sitting position (25 G Ballpen N = 336, 25 G Sprotte N = 334)
Interventions

  1. 25 G Ballpen needle group): Rüsch, Kernen, Germany

  2. 25 G Sprotte needle group: Pajunk, Geisingen, Germany
Outcomes Outcomes were not classified as primary or secondary

  1. Incidence of PDPH

  2. Side effects
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 reported

  6. Declared conflicts of interest: no
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "according to a randomization protocol that was created by a computerized program for each study site". (page 513)
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: "During postoperative Day 2 and 4, all patients were visited by an anesthesiologist who was blinded to the type of spinal needle" (page 514)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 23 patients (3.2%) 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