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
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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
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Interventions |
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
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
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Outcomes |
Outcomes were not classified as primary or secondary
Number of attempts
Final sensory level of the spinal blockade
Failure to obtain CSF
Time for placement of spinal anaesthesia
Amount of intraoperative analgesic supplement required
PDPH
Severity of PDPH
Any headache
Number of days of PDPH
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Notes |
Trial registration: not stated
Funder: this study was supported in part by an unrestricted education grant from B. Braun Medical, Inc.Medical Devices Company
Role of funder: not stated
A priori sample size estimation: yes
Conducted: not stated
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 |