Mondor 2010.
| Methods | RCT Approved by the ethics committee and signed informed consent given by each patient Setting: Canada Funding: departmental |
|
| Participants | 44 patients scheduled for major liver resection | |
| Interventions |
Treatment group: TEA (T7‐T8 or T8‐T9) with 0.5% bupivacaine during surgery only (n = 22) Control group: sham epidural (n = 22) All participants were administered an intrathecal injection of morphine 0.5 mg and fentanyl 15 mcg at L2 to L3 or L3 to L4 plus general anaesthesia and IV PCA morphine after surgery |
|
| Outcomes | VAS scores at rest at 6, 24 and 48 hours obtained from study authors VAS scores on movement at 6, 24 and 48 hours obtained from study authors Hospital LOS |
|
| Notes | No post‐dural puncture headache or neurological complications reported in relation to the intrathecal or epidural technique Additional information received from study authors |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomized (by computer)" |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "sham epidural" ‐ In the placebo group, the skin was punctured with the Tuohy needle, but it was not advanced beyond the subcutaneous tissue. The epidural catheter was then taped in a sponge on the patient’s back, and NaCl 0.9% infusion at 3 mL/h replaced the local anaesthetic infusion. After the real or sham epidural, the anaesthesiologist who performed the technique was replaced by the anaesthesiologist in charge of the case. At the end of surgery, a 3‐mL bolus of bupivacaine 0.5% was injected via the epidural catheter in the epidural group, or 3 mL of NaCl 0.9% in the placebo group, and the thoracic epidural catheter was removed by the same anaesthesiologist who inserted it (M.E.M.) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "sham epidural" ‐ All outcome measures were recorded by the same research nurses at 6, 9, 12, 18, 24, 36 and 48 hours after regional anaesthesia. PaCO2 also was recorded at 6 hours after intrathecal morphine injection" "Patient randomization was not known by any of the patients; anesthesiologists in charge of the cases and their assistants (residents, respiratory therapists); surgeons; nurses in the operating room, in the PACU, in the intensive care unit, or on the floor; and the research nurse. Only 1 person had information on patient randomization (M.E.M.)" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was excluded because he died of a massive thrombotic cerebrovascular accident 12 hours postoperatively |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Low risk | Groups well balanced |