Seeling 1991.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Germany Funding: unspecified |
|
| Participants | Patients undergoing infrarenal abdominal aortic aneurysm; gastric or bladder cancer cystectomy; pancreatic head resection; or Whipple's procedure | |
| Interventions |
Treatment group: thoracic or lumbar (according to surgical site; catheter inserted and tested the day before surgery when possible) epidural analgesia with 0.1 mL/kg (ideal body weight) of 0.25% bupivacaine plus morphine 60 mcg/mL up to postoperative day 3 (n = 95) Control group: thoracic epidural analgesia with morphine 0.05 mg/kg in 10 mL of isotonic saline every 8 hours as needed (n = 90) or IV patient‐controlled analgesia with morphine (n = 107) General anaesthesia for all participants |
|
| Outcomes | Time to first faeces: "We were able to capture this event for 85 participants of group epidural bupivacaine plus morphine, 86 of epidural morphine and 104 of IV morphine group. There was no difference between groups: 1.33 hours versus 1.30 and 1.30 hours; alpha = 0.15 > 0.0167" Pain at rest and on coughing at 8H00, 12H00, 16H00 and 20H00 on postoperative days 1, 2 and 3: "patients in the epidural bupivacaine plus morphine group had lower pain scores on maximal coughing compared with the two other groups", "the difference between the epidural bupivacaine morphine group and the two other groups for all time points until 12H00 of postoperative day 3 were lower than 0.0063", "Pain at rest at 8H00 on postoperative day 1 was lower for epidural bupivacaine morphine compared with epidural morphine and IV (P < 0.01) and remained so until 16H00. The difference was no longer seen at 20H00. The difference was significant again in the mornings of postoperative days 2 and 3" Length of stay in hospital: epidural bupivacaine plus morphine 19: 1.69 days vs 18: 1.61 days and 19; 1.65 days: alpha 0.52 > 0.025; means and standard deviations for normally distributed values or medians and standard deviation factors |
|
| Notes | Data not extractable; letter sent to study authors on 23 June 2015. We received no reply | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number Geigy tables and stratified for age > or < 60 years, gender and types of operations |
| 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 | Numbers of drop‐outs = 20 for epidural bupivacaine with morphine, 18 for epidural morphine and 9 for IV |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Not in intention‐to‐treat: failed catheter epidural insertion and failed analgesia were not included in the analysis |