Kumar 2004.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: India Funding: unspecified |
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Participants | 48 ASA 1 or 2 patients aged between 20 and 70 years undergoing major abdominal surgery | |
Interventions |
Treatment group: TEA (T12‐L1 with the catheter advanced 3 cm passed the needle tip) with bupivacaine 0.25% started after the end of surgery (n = 16) Control group: TEA with morphine 0.02 mg/mL (n = 16) General anaesthesia for all participants |
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Outcomes | VAS (visual analogue) scores at 22 (taken as 24 hours) and 40 (taken as 48 hours) (taken as at rest) | |
Notes | One group with a combination of bupivacaine and morphine ‐ not retained Duration of treatment unspecified ‐ taken as 48 hours (i.e. equivalent to measurements) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "at random", no details |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "double‐blind" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "double‐blind" |
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 | Unclear risk | Type of surgery not mentioned Unilateral sensory impairment and motor weakness in 3/16 participants, retained in their group |