Tsui 1997.
Methods | RCT Approved by the ethics committee and written informed consent obtained from all patients Setting: China Funding: unspecified |
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Participants | 120 ASA class 1 or 2 female patients scheduled for gynaecological lower abdominal operations through a vertical midline incision | |
Interventions |
Treatment group: LEA (L2‐L3 or L3‐L4) with bupivacaine 0.0625% and fentanyl 3.3 mcg/mL adjusted for VAS scores < 3/10 at rest for 48 hours (n = 57) Control group: IV PCA with morphine adjusted for VAS scores < 3/10 at rest (n = 54) General anaesthesia for all participants |
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Outcomes | Vomiting | |
Notes | 32% of participants in the epidural group had limb weakness Study authors contacted for additional information. Replied that original data are no longer available |
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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 | "Before the preoperative visit, patients were randomly allocated" |
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 | 9 dropped out owing to blockage of the IV cannula for PCA administration (n = 5), extrusion of the epidural catheter during the study period (n = 2) or failure to receive a vertical midline incision (n = 2) |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |