Donatelli 2006.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Canada Funding: charity |
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Participants | 16 patients undergoing elective colorectal surgery Exclusion criteria were more than 20% loss of body weight in the past 6 months, evidence of metastatic disease, severe cardiac and respiratory diseases, diabetes with albumin < 35 g/L and anaemia (haemoglobin < 100 g/L) |
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Interventions |
Treatment group: thoracic (T9‐T11) epidural loaded with 15 mL of 0,5% bupivacaine for a sensory block from T4 to S5, maintained with 5 mL of 0.25% bupivacaine every hour during surgery followed by an infusion of 0.1% bupivacaine plus fentanyl 2 mcg/mL at 8 to 15 mL/h for 48 hours after surgery (n = 8) Control group: IV patient‐controlled analgesia with morphine (n = 8) General anaesthesia for all participants |
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Outcomes | Pain scores at rest and on movement (coughing) at 24 and 48 hours | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "using a computer‐generated randomization schedule" |
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 | 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 except for age; participants in the epidural group were older (65 vs 59 years) |