St‐Onge 1997.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Canada Funding: industry (in part) |
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| Participants | 60 ASA 1 to 3 patients (aged 18 to 75 years) undergoing elective abdominal surgery, vascular or bowel resection surgery, requiring a midline incision | |
| Interventions |
Treatment group: TEA (T10‐L1) with bupivacaine 0.05% (n = 20) or 0.1% (n = 20) and meperidine 1 mg/mL adjusted for VAS score, 4/10. These 2 groups were fused. Exact duration unspecified, taken as 48‐hour duration of data collection for epidurally administered meperidine Control group: TEA with meperidine 1 mg/mL only (n = 19) General anaesthesia for all participants |
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| Outcomes | VAS scores at rest 24 (period 24 to 36 hours taken as 24 hours) and 48 hours (period 36 to 48 hours taken as 48 hours) VAS scores on movement (sitting) (period 24 to 36 hours taken as 24 hours) and at 48 hours (period 36 to 48 hours taken as 48 hours) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "randomized", no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double‐blind" ‐ The infusion solution was prepared by the hospital pharmacy, and the anaesthetist and the investigator were blinded to which solution was used |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Double‐blind" ‐ The infusion solution was prepared by the hospital pharmacy and the anaesthetist, and investigators were blinded to which solution was used |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was excluded because of complications unrelated to the investigation in the immediate postoperative period. Six participants did not complete the study, but each 12 hours of completed data was kept for analysis. Of the 6 participants, 1 had the technique interrupted because of surgical complications (haemorraghic shock), 2 had epidural catheter dislodgement and 3 (2 in the 0% and 1 in the 0.10% group) did not complete the 48 hours because of unsatisfactory analgesia in spite of a well‐positioned catheter |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Supported, in part, by Faulding (Canada) Inc, Vaudreuil, Quebec, and Nellcor Inc, Hayward, California Not in intention‐to‐treat |