Benzon 1994.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: United States of America Funding: industry |
|
| Participants | 120 patients who underwent major abdominal or genitourinary procedures. Gastrointestinal procedures included gastrectomy, abdominoperineal resection and small bowel and colon resection. Genitourinary procedures included nephrectomy, radical nephrectomy and radical prostatectomy with pelvic lymph node dissection | |
| Interventions |
Treatment group: epidural fentanyl 10 mcg/mL with 0.1% (n = 30), 0.15% (n = 30) or 0.2% (n = 30) bupivacaine for 24 hours Control group: epidural fentanyl 10 mcg/mL in preservative‐free saline (n = 30) Epidural catheter was placed as close to the site of surgical incision as possible (i.e. low thoracic level for nephrectomy or gastrectomy, and lumbar level for prostatectomy and pelvic lymph node dissection). Initial rate of 5 mL/h adjusted to maintain a VAS ≤ 3. General anaesthesia for all participants |
|
| Outcomes | Vomiting | |
| Notes | "One in Group I (Epidural fentanyl only) with postoperative numbness was diagnosed with a lumbar plexopathy secondary to postoperative intrapelvic hematoma" Study authors contacted on 23 February 2014, replied to our request on 24 February 2014, that additional information is not available |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The patients were randomized, via a random number generator" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All drugs for infusion were prepared by the hospital pharmacy just before use and were labelled simply "study drug" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All drugs for infusion were prepared by the hospital pharmacy just before use and were labelled simply "study drug" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All results provided |
| Other bias | Low risk | Groups well balanced |