Mann 2000.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: France Funding: charity |
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Participants | 70 patients older than 70 years of age, ASA status 1 or 2 (age criterion taken away), normal preoperative mental status defined by a modified Abbreviated Mental Test score, undergoing elective major abdominal surgery for cancer via midline or bi‐subcostal incision | |
Interventions |
Treatment group: TEA (PCEA) with bupivacaine 0.125% and sufentanil 0.5 mcg/mL (mean 79 hours) (n = 35) Control group: IV morphine PCA (n = 35) General anaesthesia for all participants |
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Outcomes | Time to first faeces (hours) VAS scores at rest at 6 to 8 (postop 0, evening), 24, 48 and 72 hours Anastomotic leak |
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Notes | Subcutaneous abscess or neurological complications related to the epidural catheter did not develop in any participant Study authors contacted on 8 July 2014, for additional information but did not reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "...the patients were assigned to receive, as determined by a table of random numbers, either general anaesthesia and postoperative morphine (PCA group) or general anaesthesia combined with epidural bupivacaine sufentanil anaesthesia (PCEA group)" |
Allocation concealment (selection bias) | Low risk | "The day before surgery and after obtaining written informed consent, all subjects received written and verbal instructions for use of PCA or PCEA and were instructed to balance analgesia against sedation. Then, the patients were assigned..." |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Participants were assessed for return of gastrointestinal function 2 times a day by a physician who systematically questioned participants and consulted nurse observations until the return of flatus, faeces and eating without nausea |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 6 participants did not complete the postoperative study and were excluded from postoperative data analysis because of absence of surgical resection (2 in each group) or refusal to use the patient‐controlled device with requirement of conventional analgesia (2 in the PCEA group and 0 in the PCA group) |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |