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

Schmittner 2010.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Germany

  • Multisite: no

  • International: no

  • Needle type design used: Quincke

  • Needle diameter used: 25 vs 29

  • Procedure: subarachnoid anaesthesia

  • Number of attempts (1 attempt): 87.3% vs 84.9%

  • Site of the puncture: L3‐4

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

  • Median or paramedian technique: midline approach

  • Type of anaesthesia: 1 mL of 0.5% bupivacaine

  • Patient position: sitting position
Participants 1. 216 patients ASA I to III, undergoing in‐house and ambulatory anorectal surgery, performed in lithotomy position, were enrolled
Exclusion criteria: contraindications against spinal anaesthesia, patients considered to be ASA status IV–I, operation techniques other than in lithotomy position and prior participation in the study.
After inclusion of 216 patients, the study was terminated when interim analysis showed unexpected high rates of PDPH in both study groups.
Patients randomized to:

  • 25 G Quincke group: 106 patients (49.07%)

  • 29 G Quincke group: 110 patients (50.93%)


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

  • Age (mean, SD): 25 G Quincke group: 51.6, 12.6; 29 G Quincke group: 45.5, 12.3

  • Weight (mean, SD): 25 G Quincke group: 82.7, 16.9; 29 G Quincke group: 79.3, 19.4

  • Height (mean, SD): 25 G Quincke group: 171.5, 8.5; 29 G Quincke group: 172.2, 10
Interventions

  • 25 G Quincke needle with introducer (Spinocan 0.53 × 88 mm − G 25 × 3 1/2, B. Braun, Melsungen, Germany)

  • 29 G Quincke needle with introducer (Spinocan 0.35 × 88 mm − G 29 × 3 1/2, B. Braun, Melsungen, Germany)
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Time to onset

  3. Duration of PDPH
Notes

  1. Trial registration: ISRCTN: 11431649

  2. Funder: B. Braun, Melsungen, Germany

  3. Role of funder: provision of needles

  4. A priori sample size estimation: yes

  5. Conducted: March to August 2008

  6. Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Upon arrival in the operating theatre the patients were randomly allocated 1:1 using sealed envelopes in blocks of 20 to receive a spinal saddle block with either a 25‐G or a 29‐G Quincke type spinal needle" (page 776)
Allocation concealment (selection bias) Low risk Quote: "Upon arrival in the operating theatre the patients were randomly allocated 1:1 using sealed envelopes in blocks of 20 to receive a spinal saddle block with either a 25‐G or a 29‐G Quincke type spinal needle" (page 776)
Blinding of participants (performance bias) Low risk Quote: "Study participants were blinded to the type of needle used." (page 776)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "A consultant anaesthesiologist who was blinded towards the needles used and who was not involved in the study assessed the incidence of PDPH" (page 776)
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