Muehling 2009.
Methods | RCT Approved by the local ethics committee and written informed consent obtained from all patients clinicaltrials.gov identifier NCT 00615888 Setting: Germany Funding: unspecified |
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Participants | All patients admitted with indications for elective open repair of an infrarenal aortic aneurysm were eligible for the study | |
Interventions |
Treatment group: TEA (T7 and T10) in PCEA with ropivacaine 0.2% and sufentanil 2 mcg/mL (n = 50). Used intraoperatively and postoperatively for an unspecified duration Control group: IV PCA with piritramide (n = 49) General anaesthesia for all participants |
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Outcomes | Hospital LOS | |
Notes | Study authors contacted on 21 July 2014, for additional information but did not reply | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomized block design prepared by the Department of Biometry, University of Ulm" |
Allocation concealment (selection bias) | Unclear risk | "After they gave written informed consent, patients were randomly assigned" |
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 | One participant in each group withdrew written informed consent and was excluded, leaving 50 participants in the traditional group and 49 in the fast‐track group, who were studied in an intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Other treatment modalities differ between the 2 groups as per protocol Analysed in intention‐to‐treat |