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

Tabedar 2003.

Methods
  • Design: prospective, randomized, double‐blind study, 2 arms

  • Country: Nepal

  • Multisite: no

  • Needle type design used: diamond vs pencil

  • Needle diameter used: 25 G and 26 G

  • Number of attempts: 1, 2 or more than 2

  • Procedure: midline approach

  • Site of the puncture: L2‐L3 or L3‐L4

  • Training level of those who administered the puncture: unclear

  • Median or paramedian technique: unclear

  • Type of anaesthetic: 2.9 ml 0.5% heavy bupivacaine

  • Patient position: sitting

Participants 1. 60 ASA I and II primi and multipara parturient undergoing elective caesarean section aged 19 to 40 years. Exclusion criteria: parturient refusal, weight more than 75 kg, eclampsia/pre‐eclampsia, bleeding disorders
Patients randomized to:
  • Quincke (30)

  • Eldor (30)


2. 6 (8.21%) patients lost to follow‐up because no cerebrospinal fluid was obtained with the Sprotte needle
3. Main characteristics:
  • Quincke: age 19 to 33

  • Eldor: age 19 to 35

Interventions
  1. 25 G Quincke: no further details were provided

  2. 26 G Eldor: no further details were provided

Outcomes Outcomes were not classified as primary or secondary
  1. Headache

  2. PDPH

  3. Attempts

Notes
  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: not stated

  5. Conducted: not reported

  6. Declared conflicts of interest: not reported

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: "60 ASA I and II primi and multipara parturient undergoing elective caesarean section aged 19‐40 years were randomly divided (...)" (page 264)
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 Unclear risk Insufficient information to score this item as low or high risk of bias
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