Broekema 1998.
| Methods | RCT Approved by the ethics committee and informed consent obtained Setting: The Netherlands Funding: unspecified |
|
| Participants | 90 patients, 18 to 76 years of age, ASA physical status 1 to 3, scheduled for elective major abdominal surgery (abdominal aortic surgery, pancreaticoduodenectomy, extended hepato‐biliary surgery, colonic or other upper abdominal) | |
| Interventions |
Treatment groups: TEA (catheter inserted 4 to 6 cm passed the needle tip) with bupivacaine and morphine (n = 29) or sufentanil (n = 30) intraoperatively and postoperatively for > 48 hours. Rate adjusted according to pain (4 at rest and 6 on movement) Control group: IM morphine (n = 28) General anaesthesia for all participants. Co‐analgesia with paracetamol ± diclofenac |
|
| Outcomes | VAS scores (scale from 0 to 10) at rest at 24, 48 and 72 hours VAS scores (scale from 0 to 10) on movement at 24, 48 and 72 hours |
|
| Notes | Technical difficulties or complications of the epidural technique recorded. No neurological sequelae Control group divided into 2 groups for comparisons with each treatment group |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomly assigned to 1 of 3 groups: no details |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Both participant and investigator were informed about the nature of the treatment ‐ IM or epidural |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Route of administration unknown to observers (3 medical students), who assessed postoperative analgesia and side effects. Participants in the IM group received a sham epidural catheter on the skin of the back. This catheter was connected to an empty syringe in an infusion pump, which was covered postoperatively to shield its contents from the observer. The same cover was used for participants in the epidural groups |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 participants were excluded: 2 in the IM and 1 in the EM group. Participant 7 (IM group) developed sepsis after surgery and was mechanically ventilated for 4 days. Participant 22 (EM group) lost 22 L of blood and died from multiple‐organ failure 8 days after surgery. Participant 80 (IM group) developed acute respiratory distress syndrome (ARDS); he was tracheally extubated 5 days after surgery |
| Selective reporting (reporting bias) | Low risk | All results reported |
| Other bias | Low risk | Groups well balanced All analyses performed on an intention‐to‐treat basis. This principle was applied if the epidural technique failed and in cases of dysfunction of the epidural catheter, premature removal or dislocation of the epidural catheter |