Fant 2013.
Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Sweden Funding: governmental |
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Participants | 26 patients (ASA physical status 1 to 2) in the age group 50 to 75 years, undergoing elective radical retropubic prostatectomy | |
Interventions |
Treatment group: TEA (T10‐T12) with ropivacaine 0.2% and sufentanil 1 mcg/mL for 48 hours (n = 12) Control group: IV PCA with morphine (n = 14) General anaesthesia for all participants |
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Outcomes | VAS scores at rest at 8, 24 and 48 hours VAS scores on movement at 8, 24 and 48 hours |
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Notes |
NCT01367418 All participants in Group E received an epidural catheter successfully; no complications were associated with catheter insertion |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Group randomization and concealed allocation was done using cards inserted into opaque, sealed envelopes by an independent person not involved in the study" |
Allocation concealment (selection bias) | Low risk | "Group randomization and concealed allocation was done using cards inserted into opaque, sealed envelopes by an independent person not involved in the study" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "The study was only blinded to laboratory personnel involved in biochemical assays" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | "The study was only blinded to laboratory personnel involved in biochemical assays" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 opioid based regimen patient switched to non steroid anti‐inflammatory drugs |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |