Schumann 2003.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: United States of America Funding: governmental |
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| Participants | 114 patients, aged 18 to 80 years, undergoing gastric bypass surgery as a treatment for obesity Exclusion criteria were significant cardiovascular, hepatic, pulmonary, renal, hematological, neurological or psychiatric disease; known hypersensitivity to any of the study drugs; history of drug or alcohol abuse within the previous year; pre‐existing long‐ or short‐term pain and previous abdominal surgery or any surgery in the previous 3 months |
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| Interventions |
Treatment group: thoracic epidural analgesia started during surgery, followed by an infusion of 0.1% bupivacaine and 1 mg/mL of meperidine after surgery (n = 39) Control group: IV patient‐controlled analgesia with morphine (n = 36) General anaesthesia and postoperative co‐analgesia with non‐steroidal anti‐inflammatory drugs available for all participants |
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| Outcomes | Pain Length of stay in hospital: "was equivalent between the three groups" |
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| Notes | Study also includes a group with wound infiltration Data not extractable. Study authors replied to our request that additional information is not available |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Successive envelopes containing allocation codes were opened by one investigator when patients were in the preoperative holding area, after consent had been obtained" |
| Allocation concealment (selection bias) | Low risk | "Successive envelopes containing allocation codes were opened by one investigator when patients were in the preoperative holding area, after consent had been obtained" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "open‐label" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "open‐label" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | "Decreases in the number of patients contributing data points across time were not because of additional dropouts but instead reflected incomplete capture or documentation of pain scores by ward nursing staff (80% of subjects at time 0 versus 51% at 48 hours)" 3 of 39 participants randomized to the epidural group were dropped because the epidural catheter was not placed because an intraoperative significant adverse event occurred and one of the cases was a revision Additionally, 4 participants from the IV group were dropped from the study because of unexpected intraoperative or perioperative complications not attributable to the analgesic regimen |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | "All three treatment groups were equivalent with respect to the demographic characteristics of age, sex, and body mass index" Not in intention‐to‐treat |