Mallinder 2000.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: United Kingdom Funding: industry |
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Participants | 40 ASA 1 to 3 patients scheduled for elective colorectal surgery | |
Interventions |
Treatment group: LEA (L2‐L3 or L3‐L4) with bupivacaine 0.25% during surgery (n = 12) Control group: IV morphine (n = 20) General anaesthesia for all participants |
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Outcomes | 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 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 | Unclear risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | High risk | Technical monitoring difficulties meant that complete data were collected on only 32 participants (12 epidural and 20 morphine). |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Trend towards longer operating time (143 (54) vs 130 (45) minutes) and greater blood loss (1045 (753) vs 785 (887) mL) in the morphine group, but this did not reach significance Not in intention‐to‐treat |