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

Devcic 1993.

Methods

  • Design: factorial 2 x 2 (needle x fentanyl)

  • Country: USA

  • Multisite: no

  • Needle tip used: 24 G Sprotte vs 25 G Quincke

  • Needle diameter used: 24 vs 25

  • Number of attempts: unknown

  • Procedure: spinal anaesthesia

  • Site of the puncture: L2‐5

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: midline approach

  • Type of anaesthetic: hyperbaric 0.75% bupivacaine local anaesthetic with/without 20 µg of fentanyl

  • Patient position: sitting or lateral position
Participants 1. 200 patients enrolled (healthy obstetric patients requiring caesarean section)
Exclusion criteria: patients in whom labour epidural analgesia had been attempted or performed previously, or in whom a spinal anaesthetic had been attempted with other needles
4 patients in the Sprotte group (3 Sprotte with fentanyl and 1 Sprotte with plain local anaesthetic) and 2 in the Quincke group (1 randomized to receive fentanyl and 1 Sprotte with plain local bupivacaine) were not available for follow‐up

  • Patients randomized to:

    • 24 G Sprotte + fentanyl: 47 (94%)

    • 24 G Sprotte only: 49 (98%)

    • 25 G Quincke + fentanyl: 49 (98%)

    • 25 G Quincke only: 49 (98%)


2. 6 (6%) patients randomized were excluded because exclusion criteria had been missed or because they could not be contacted

  • Patients analysed:

    • 24 G Sprotte + fentanyl: 47

    • 24 G Sprotte only: 49

    • 25 G Quincke + fentanyl: 49

    • 25 G Quincke only: 49


3. Main characteristics of patients:

  • Age (mean, SD):

    • 24 G Sprotte + fentanyl: 28.2, 5.8

    • 24 G Sprotte only: 29.5, 4.4

    • 25 G Quincke + fentanyl: 28.3, 5.6

    • 25 G Quincke only: 28.7, 5.5

  • Weight (mean, SD):

    • 24 G Sprotte + fentanyl: 76.2, 15.8

    • 24 G Sprotte only: 78.3, 15.4

    • 25 G Quincke + fentanyl: 82.6, 16.1

    • 25 G Quincke only: 79.9, 18.1

  • Height (mean, SD):

    • 24 G Sprotte + fentanyl: 165.1, 8.4

    • 24 G Sprotte only: 163.9, 7.9

    • 25 G Quincke + fentanyl: 165.3, 7.6

    • 25 G Quincke only: 163.9, 7
Interventions

  1. 24 G Sprotte + fentanyl

  2. 24 G Sprotte only

  3. 25 G Quincke + fentanyl: needle bevel was oriented parallel to the longitudinal fibres

  4. 25 G Quincke only: needle bevel was oriented parallel to the longitudinal fibres
Outcomes Outcomes were not classified as primary or secondary

  1. PDPH

  2. Severity of headache
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: 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: "This randomized, blinded study (…)." (page 222)
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: "all patients were evaluated daily during the first 4 postoperative days by the designated nurse, who was blinded to the type of needle and medication used (...) Investigators conducting telephone follow‐up were blinded to the type of needle and anesthetic solution used". (page 223)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 4 patients (8%) 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