Jayr 1993.
| Methods | RCT Approved by the ethics committee and informed consent obtained Setting: France Funding: charity (plus a contribution from the industry) |
|
| Participants | 163 patients undergoing elective major abdominal surgery for cancer via midline or bilateral subcostal incision | |
| Interventions |
Treatment group: TEA (T7‐T11) inserted before surgery. Used intraoperatively and postoperatively. Bupivacaine for surgery and bupivacaine 0.125% plus morphine for postoperative analgesia for 5 days (n = 78) Control group: morphine infusion through a subcutaneous catheter for 5 days (n = 75) General anaesthesia for all participants |
|
| Outcomes | VAS scores at rest at 24, 48 and 72 hours VAS scores on coughing at 24, 48 and 72 hours (taken as on movement) Hospital LOS |
|
| Notes | Recovery of intestinal gas transit occurred earlier in the EP group than in the SC group (P value < 0.05). Data expressed as cumulative % of participants with recovery from day 2 to day 5 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Stratified by history of bronchopulmonary disease |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Subcutaneous catheter located and dressed as an epidural. Solutions filled and labelled by the pharmacy |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Subcutaneous catheter located and dressed as an epidural. Solutions filled and labelled by the pharmacy |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 participants excluded from analysis: early postoperative complications (n = 4), ventilator dependence (n = 1), associated thoracotomy (n = 1), intraoperative anaphylaxis (n = 1) and surgery cancelled after randomization (n = 3) ‐ 4 from the epidural group |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups well balanced except that more smokers were included in the subcutaneous group Not in intention‐to‐treat |