Aygun 2004.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Turkey Funding: unspecified |
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Participants | 80 ASA 1 and 2 patients aged 18 to 60 years undergoing elective lower abdominal surgery | |
Interventions |
Treatment group: LEA (catheter inserted 3 to 4 cm) with ropivacaine 0.125% plus fentanyl 2 mcg/mL for 24 hours (Gr 4; n = 20) Control groups: IV tramadol for 24 hours (Gr 1; n = 20) General anaesthesia for all participants |
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Outcomes | VAS at 6 and 24 hours (unclear, therefore taken as at rest). A value of 0.001 has been entered as SD when the SD was reported as 0 | |
Notes | Study also includes 2 groups that were not retained: 1 group with epidurally injected tramadol and 1 group with IV fentanyl infusion | |
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 | High risk | See above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All results provided |
Other bias | Low risk | Groups well balanced |