Rockemann 1996.
| Methods | RCT Approved by the ethics committee and written informed consent obtained Setting: Germany Funding: unspecified |
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| Participants | 142 patients undergoing various types of major abdominal surgery Exclusion criteria were age > 65 years, creatinine level > 140 micromol/L, long‐term treatment with analgesics or corticosteroids, allergy against 1 of the study substances and contraindications against epidural puncture |
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| Interventions |
Treatment group: thoracic (T8‐T10; inserted on the day before surgery at 7 cm; position confirmed by epidurography and tested with 5 mL of mepivacaine 1%) epidural injected with 0.2 mL/kg of 1% mepivacaine plus 75 mcg/kg of morphine before surgical incision (n = 48) or before wound closure (n = 48) Control group: no epidural analgesia (n = 46) General anaesthesia for surgery and IV patient‐controlled analgesia with morphine for postoperative analgesia for 5 days for all participants |
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| Outcomes | Pain scores: "Median visual analogue scale pain intensities were < 3 cm and did not differ among the groups" | |
| Notes | For this study, for our selected outcomes, an exact P value (0.001) was given only for the difference between group 2 and group 3 at 8 AM on postoperative day 1; all other values were said to be not statistically significant. Retaining this single value would have been viewed as "selective reporting" by us Study authors contacted on 26 July 2014, but did not reply | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "prerandomized list unknown to the investigator recruiting the patients" |
| Allocation concealment (selection bias) | Low risk | "prerandomized list unknown to the investigator recruiting the patients" |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | "Participants and personnel involved in the postoperative care and data collection were blinded regarding the allocation of the patients to groups 1 and 2 (i.e. pre‐ or post‐incision administration of study drugs). Group 3 participants did not receive catheters and consequently could not be blinded" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | "Participants and personnel involved in the postoperative care and data collection were blinded regarding the allocation of the patients to groups 1 and 2 (i.e. pre‐ or post‐incision administration of study drugs). Group 3 participants did not receive catheters and consequently could not be blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants in the 2 epidural groups (n = 3) were excluded from the analysis if they received epidural bupivacaine after surgery |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Unclear risk | Groups well balanced Not in intention‐to‐treat |