De Pietri 2006.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Italy Funding: unspecified |
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Participants | 50 adult patients of both sexes, ASA 1 and 2, scheduled for liver surgery. | |
Interventions |
Treatment group: TEA (T9‐T10 or T10‐T11) with ropivacaine 0.2% for 96 hours or longer (n = 25) Control group: intrathecal morphine 0.2 mg followed by IV PCA with morphine (n = 25) General anaesthesia for all participants |
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Outcomes | VAS at rest at 8, 24 and 48 hours VAS on coughing (taken as on movement) at 8, 24 and 48 hours |
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Notes | "Patients were evaluated for post‐dural puncture headache and radicular back pain; muscle weakness and sensory deficit, as early signs of spinal cord compression caused by hematoma, were also evaluated" | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly allocated to 2 groups by a computer‐generated list |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Postoperative clinical monitoring of participants and evaluation of VAS were managed by investigators blinded to the analgesic technique used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Postoperative clinical monitoring of participants and evaluation of VAS were managed by investigators blinded to the analgesic technique used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up mentioned: "no patient was excluded from the study" |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | Groups well balanced |