Jorgensen 2001.
Methods | RCT Approved by the ethics committee and written informed consent obtained from each patient Setting: Denmark Funding: charity |
|
Participants | 60 ASA 1 or 2 women aged 18 to 75 years undergoing elective abdominal hysterectomy through a Phannenstiel or median incision | |
Interventions |
Treatment groups: TEA with lidocaine intraoperatively only (n = 20) or TEA with lidocaine intraoperatively and bupivacaine 0.2% for 24 hours after surgery (n = 20) Control group: no epidural (n = 20) General anaesthesia, paracetamol, ketorolac and IM (?) morphine for all participants |
|
Outcomes | Time to first flatus Time to first faeces |
|
Notes | Study authors contacted on 27 June 2014, but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding between the 2 epidural groups only |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Blinding between the 2 epidural groups only |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 7 participants excluded after randomization; replaced with new sealed envelopes |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced |