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

Pan 2004.

Methods
  • Design: parallel‐group (2 arms)

  • Country: USA

  • Multisite: no

  • Needle tip used: 26 G Atraucan vs 25 G Whitacre

  • Needle diameter used: 26 vs 25

  • Number of attempts: 1.5 vs 1.6

  • Procedure: anaesthesia

  • Site of the puncture: L2‐3, L 3‐4 or L4‐5

  • Training level of those who administered the puncture: anaesthesiology residents or senior nurse anaesthetist students, with close supervision of attending anaesthesiologists, performed the spinal anaesthetic procedures

  • Median or paramedian technique: midline

  • Type of anaesthetic: 75 mg of 5% lidocaine in 7.5% dextrose injected intrathecal

  • Patient position: sitting position

Participants 1. 215 American Society of Anesthesiology Class I to II postpartum patients presenting for elective postpartum bilateral tubal ligations under spinal anaesthesia were enrolled
Patients randomized to:
  • 26 G Atraucan group: 109

  • 25 G Whitacre group: 106


2. 11 patients (5.1%) were excluded from analysis, because of loss to follow‐up, cancellation of surgery or inability to identify the sub‐arachnoid space
Patients analysed:
  • 26 G Atraucan group: 104

  • 25 G Whitacre group: 100


3. Main characteristics of patients:
  • Age (mean, SD): 26 G Atraucan group: 28.5; 25 G Whitacre: 28.5

  • Weight (mean, SD): 26 G Atraucan group: 76, 14; 25 G Whitacre: 78, 18

  • Height (mean, SD): 26 G Atraucan group: 164, 6; 25 G Whitacre: 162, 8

Interventions
  1. 26 G Atraucan spinal needles (B. Braun Medical, Bethlehem, PA) (outside diameter 0.45 mm; length 8.89 cm) were used with the bevel of the needles turned parallel to the longitudinal axis of the patient’s vertebral column

  2. 25 G Whitacre spinal needles (Becton‐Dickinson, Rutherford, NJ) (outside diameter 0.5 mm; length 8.89 cm) were used with the terminal orifice of the needle facing cephalad to the patient

Outcomes Outcomes were not classified as primary or secondary
  1. Number of attempts

  2. Final sensory level of the spinal blockade

  3. Failure to obtain CSF

  4. Time for placement of spinal anaesthesia

  5. Amount of intraoperative analgesic supplement required

  6. PDPH

  7. Severity of PDPH

  8. Any headache

  9. Number of days of PDPH

Notes
  1. Trial registration: not stated

  2. Funder: this study was supported in part by an unrestricted education grant from B. Braun Medical, Inc.Medical Devices Company

  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) Low risk Quote: "The patients were randomized by means of a computer‐generated random number table into either" (page 360)
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: "Postoperatively, an investigator who was blinded to the group assignment interviewed the patients daily while in the hospital" (page 360)
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5% of patients were lost to follow‐up
Selective reporting (reporting bias) High risk Adverse events, additional to PDPH, were not reported
Other bias Unclear risk The role of funder is unclear