Seeling 1990a.
Methods | RCT Setting: Germany Funding: unspecified |
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Participants | 75 participants undergoing major abdominal surgery | |
Interventions |
Treatment group: thoracic epidural analgesia started after surgery with bupivacaine 0.5% for the first bolus and 0.25% for subsequent doses given as 0.15 mL/kg every 2 hours, until 19H00 the day after surgery (n = 15) Control group: IV buprenorphine (n = 16) General anaesthesia for all participants |
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Outcomes | Pain at rest and on coughing at 24 hours after surgery | |
Notes | Study also includes 2 other groups: Group III: buprenorphine given epidurally. This group was not retained, as something other than just local anaesthetic, opioid or epinephrine, was injected epidurally Group IV: bupivacaine plus buprenorphine given epidurally, also excluded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomly divided" |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
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Incomplete outcome data (attrition bias) All outcomes | High risk | Owing to technical problems, 11 participants were withdrawn from the study: insufficient epidural extension (n = 4); inability to deal with the pain scale (n = 2); operative and postoperative complications (n = 4); other (n = 1). Their specific group allocation is not mentioned |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Unclear risk | Not in intention‐to‐treat |