Bisgaard 1990.
| Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Denmark Funding: unspecified |
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| Participants | 30 ASA 1 or 2 patients, aged 32 to 77 years, scheduled for elective major abdominal surgery | |
| Interventions |
Treatment group: continuous lumbar (L2‐L3 or L3‐L4; catheters inserted 10 cm) epidural analgesia with bupivacaine 0.5% 12 to 24 mL for sensory block from T4 to S5 followed by bupivacaine 0.25% plus morphine 0.06 mg/mL at 9 mL/h for 48 hours and epidural morphine for 3 to 6 days thereafter (n = 14) Control group: epidural morphine 4 to 6 mg every 4 to 6 hours for 48 hours (n = 15) General anaesthesia and postoperative supplemental intravenous pethidine as required for all participants |
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| Outcomes | Time to first flatus: "median 4.8, range 2 to 8 days versus median 4.1, range 4 to 10 days" Time to first faeces: "median 6.8, range 4 to 10 days versus median 6.5, range 4 to 11 days" Pain: "The combination of bupivacaine plus morphine provided significantly superior analgesia compared with epidural morphine alone" Colonic motility (radio‐opaque markers instilled into the stomach and carried at least 1 colonic segment): "No difference in colonic motility was observed" |
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| Notes | Results not extractable. Study authors replied to our request that the original data are no longer available | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly allocated by the closed‐envelope method" |
| Allocation concealment (selection bias) | Low risk | "randomly allocated by the closed‐envelope method" |
| 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 | "One patient in Group epidural bupivacaine with a non‐functioning epidural catheter was excluded from the study", "Another patient in Group epidural bupivacaine had a non‐lethal pulmonary embolism on the second post‐operative day; data until then are included in the study" |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups similar for sex distribution, age, weight, height and duration of surgery Not in intention‐to‐treat |