Jayr 1988.
| Methods | RCT Approved by the ethics committee and informed consent obtained Setting: France Funding: charity |
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| Participants | 150 patients scheduled for major abdominal cancer surgery through a midline incision were included | |
| Interventions |
Treatment group: TEA (T11‐T12) with bupivacaine intraoperatively and morphine alone postoperatively until postoperative day 5 (n = 74) Control group: morphine 10 mg SC every 4 hours on demand (n = 72) General anaesthesia for all participants |
|
| Outcomes | Time to first flatus VAS scores at 24, 48 and 72 hours (during the prior 24 hours, taken as at rest) |
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| Notes | Study authors contacted 1 July 2014 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Allocated to one of two treatment groups". To avoid imbalance between the numbers of participants with a previous history of respiratory disease in the 2 treatment groups, randomization was stratified for this factor |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | An epidural catheter was inserted into the subcutaneous tissue in such a way that it could not be distinguished from an epidural catheter positioned in the epidural space. Saline solution injections (2 mL) were given through this catheter twice daily. Saline solution and morphine syringes were filled and labelled by the hospital pharmacy. Nurses in charge of participants did not know the nature of the contents of the syringes |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | An epidural catheter was inserted into the subcutaneous tissue in such a way that it could not be distinguished from an epidural catheter positioned in the epidural space. Saline solution injections (2 mL) were given through this catheter twice daily. Saline solution and morphine syringes were filled and labelled by the hospital pharmacy. Nurses in charge of participants did not know the nature of the contents of the syringes |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 participants were excluded for the following reasons: early surgical complications (n = 2), unsuccessful respiratory weaning (n = 1), associated thoracotomy (n = 1) |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |