Brodner 2001.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Denmark Funding: unspecified |
|
Participants | 30 patients undergoing radical cystectomy with formation of an ileal neobladder | |
Interventions |
Treatment group: TEA (T9‐T11) with ropivacaine 0.5% during the intraoperative period and 10 mL of ropivacaine 0.2% at the end of surgery. IV piritramide thereafter (n = 15) Control group: IV piritramide (n = 15) All participants received general anaesthesia |
|
Outcomes | VAS on movement at 24, 48 and 72 hours Time to first faeces Anastomotic leak |
|
Notes | Study includes a third group collected after the first 2 groups | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly allocated", no details |
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 | No loss to follow‐up mentioned |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced except for blood losses |