MASTER Anaesthesia
Trial question
What is the effect of epidural anesthesia and analgesia in high-risk patients undergoing major abdominal surgery?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 915
915 patients (371 female, 544 male).
Inclusion criteria: high-risk status patients undergoing major abdominal surgery.
Key exclusion criteria: age < 18 years, surgery within 12 hours of admission to hospital, contraindications to the use of epidural block, infection at the epidural insertion site, or a neurological disorder.
Interventions
N=461 epidural (intraoperative epidural anesthesia and postoperative epidural analgesia for 72 h with general anesthesia).
N=454 control (general anesthesia based on a balanced technique with intraoperative and postoperative opioids).
Primary outcome
Death or at least one postsurgical morbidity at 30 days
57.1%
60.7%
60.7 %
45.5 %
30.4 %
15.2 %
0.0 %
Epidural
Control
No significant
difference ↔
No significant difference in death or at least one postsurgical morbidity at 30 days (57.1% vs. 60.7%; RR 0.94, 95% CI -0.79 to 2.67).
Secondary outcomes
No significant difference in death at 30 days (5.1% vs. 4.3%; RR 1.19, 95% CI -4.06 to 6.44).
Significant decrease in respiratory failure (23.3% vs. 30.2%; RR 0.77, 95% CI 0.12 to 1.42).
No significant difference in cardiovascular event (25.7% vs. 24%; RR 1.07, 95% CI -2.9 to 5.04).
Safety outcomes
No significant differences in renal failure, gastrointestinal failure, hepatic failure, sepsis, hematological failure,.
Significant differences in pain scores on day 1 (11.4 vs. 15.2), day 2 (9.9 vs. 11.9), and day 3 (8.0 vs. 9.7).
Conclusion
In high-risk status patients undergoing major abdominal surgery, epidural was not superior to control with respect to death or at least one postsurgical morbidity at 30 days.
Reference
John R A Rigg, Konrad Jamrozik, Paul S Myles et al. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82.
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