Carli 2002.
Methods | RCT Approved by the ethics committee and informed consent obtained Setting: Canada Funding: charity |
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Participants | 64 adult patients undergoing elective colorectal surgery for non‐metastatic conditions | |
Interventions |
Treatment group: TEA (T8 or T9 interspace) with bupivacaine 0.1% and fentanyl 2 mcg/mL or morphine 0.1 mg/mL for 4 days (n = 32) Control group: IV PCA with morphine for 3 to 4 days (n = 32) All participants received general anaesthesia |
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Outcomes | VAS at rest at 24, 48 and 72 hours VAS on movement at 24, 48 and 72 hours Time to transit taken at time to first faeces Anastomotic leak Hospital LOS |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly assigned", no details |
Allocation concealment (selection bias) | Low risk | "On the morning of the surgical procedure, the group to which the subject had been randomly assigned was revealed" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "The patients were not blinded" |
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 If the epidural block did not provide adequate analgesia, the participant continued to be included in the intention‐to‐treat analysis but was excluded from analysis addressing efficacy |