Hubler 2001.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Germany Funding: unspecified |
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| Participants | 121 patients aged 18 to 80 years with ASA physical status grade 1 to 3 who were scheduled to undergo major urological surgery (radical prostatovesiculectomy, retroperitoneal or transperitoneal nephrectomy, cystectomy, retroperitoneal lymphadenectomy) | |
| Interventions |
Treatment groups: TEA (T8‐T12) with 0.25% bupivacaine (group B; n = 22) or 0.2% ropivacaine (group R; n = 23) for 72 hours Control group: 0.5 mcg/mL of sufentanil only (group S; n = 22) for 72 hours. This group was split in half for comparison General anaesthesia for all participants |
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| Outcomes | VAS scores at rest at 8, 24, 48 and 72 hours VAS scores on coughing (taken as on movement) at 8, 24, 48 and 72 hours |
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| Notes | For VAS scores, results are provided as means and pooled SDs. Those pooled SDs were retained Study includes 2 other groups: 0.25% bupivacaine with 0.5 mcg/mL sufentanil (group BS), and 0.2% ropivacaine with 0.5 mcg/mL sufentanil (group RS), not retained "A high percentage of patients in the groups who received the local anaesthetic bupivacaine experienced some degree of muscular impairment", "Drowsiness was very common in all groups during the first 24 hours and highest in the groups that received epidural sufentanil (groups BS, RS and S)" |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomised", no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "a staff anaesthesiologist not directly involved in the study prepared study solutions" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "a staff anaesthesiologist not directly involved in the study prepared study solutions" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data on participants who withdrew their consent to participate in the study before the follow‐up period was completed were included in the analysis up to the time point of their withdrawal. 12 were excluded because of protocol violations |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Retained groups well balanced Data on participants who withdrew their consent to participate in the study before the follow‐up period was completed were included in the analysis up to the time point of their withdrawal. 12 were excluded because of protocol violations Not in intention‐to‐treat |