Kudoh 2001.
Methods | RCT Approved by the medical ethics committee and informed consent obtained from all patients and their families Setting: Japan Funding: unspecified |
|
Participants | 46 patients, ranging in age from 36 to 77 years, who were diagnosed as having schizophrenia by Diagnostic and Statistical Manual of Mental Disorders and scheduled for elective lower abdominal surgery including colectomy, hemicolectomy or sigmoidectomy for malignant tumours | |
Interventions |
Treatment group: TEA (T9‐T10 with the catheter threaded 3 cm passed the needle tip) with bupivacaine 0.25%. A bolus was given before surgery; the infusion was started after surgery and was maintained for 72 hours (n = 23) Control group: IV 4 mcg/kg buprenorphine and continuous infusion of 0.6 mcg/kg/h buprenorphine for 96 hours (n = 23) General anaesthesia for all participants |
|
Outcomes | VAS scores at 6, 24, 48 and 72 hours (taken as at rest) Time to first flatus (hours) Time to first faeces (hours) |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed via computer‐generated codes |
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 |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced |