Bois 1997.
Methods | RCT Approved by the institution and informed consent obtained Setting: Canada Funding: industry |
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Participants | 124 patients scheduled for elective abdominal aortic surgery were recruited | |
Interventions |
Treatment group: TEA (T6‐T7 or T7‐T8) with bupivacaine 0.125% and fentanyl 10 mcg/mL adjusted for VAS scores ≤ 3 for 48 hours (n = 55) Control group: IV PCA with morphine for 48 hours (n = 59) General anaesthesia for all participants |
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Outcomes | VAS scores at rest at 8 and 24 hours Hospital LOS (days) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "prospectively randomized", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 participants with TEA and 6 with PCA were excluded because of failure of Holter monitoring or epidural analgesia, or because use of analgesia was not included in the protocol |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat One participant was initially ascribed to the epidural group and received postoperative PCA instead because of a failed epidural (2 dural punctures during performance of the epidural). This participant was not excluded from the study |