Associate Professor John Rigg
915 patients were enrolled from July 1995 and May 2001 from 25 hospitals in six countries.
Australia, Hong Kong, Thailand, Malaysia, Singapore and Saudi Arabia.
Background
Epidural block is widely used to manage major abdominal surgery and postoperative analgesia, but its risks and benefits are uncertain. We compared adverse outcomes in high-risk patients managed for major surgery with epidural block or alternative analgesic regimens with general anaesthesia in a multicentre randomised trial.
Methods
915 patients undergoing major abdominal surgery with one of nine defined comorbid states to identify high-risk status were randomly assigned intraoperative epidural anaesthesia and postoperative epidural analgesia for 72 h with general anaesthesia (site of epidural selected to provide optimum block) or control. The primary endpoint was death at 30 days or major postsurgical morbidity. Analysis by intention to treat involved 447 patients assigned epidural and 441 control.
Findings
255 patients (57.1%) in the epidural group and 268 (60.7%) in the control group had at least one morbidity endpoint or died (p=0.29). Mortality at 30 days was low in both groups (epidural 23 [5.1%], control 19 [4.3%], p=0.67). Only one of eight categories of morbid endpoints in individual systems (respiratory failure) occurred less frequently in patients managed with epidural techniques (23% vs 30%, p=0.02). Postoperative epidural analgesia was associated with lower pain scores during the first 3 postoperative days. There were no major adverse consequences of epidural-catheter insertion.
Interpretation
Most adverse morbid outcomes in high-risk patients undergoing major abdominal surgery are not reduced by use of combined epidural and general anaesthesia and postoperative epidural analgesia. However, the improvement in analgesia, reduction in respiratory failure, and the low risk of serious adverse consequences suggest that many high-risk patients undergoing major intra-abdominal surgery will receive substantial benefit from combined general and epidural anaesthesia intraoperatively with continuing postoperative epidural analgesia.
The Australian National Health and Medical Research Council and the Australian and New Zealand College of Anaesthetists.
Rigg JR, Jamrozik K, Myles PS, Silbert BS, Peyton PJ, Parsons RW, Collins KS; MASTER Anaethesia Trial Study Group. Epidural anaesthesia and analgesia and outcome of major surgery: a randomised trial. Lancet. 2002 Apr 13;359(9314):1276-82.
Rigg J, Jamrozik K, Myles PS, Silbert B, Parsons RW, Collins K. Comparison of randomized and other patients eligible for the MASTER anesthesia trial. Control Clin Trial 2000; 21:244-256.
Peyton PJ, Myles PS, Silbert BS, Rigg JRA, Jamrozik K, Parsons RW, and the MASTER Anesthesia Trial Study Group. Perioperative epidural analgesia and outcome after major abdominal surgery in high risk patients. Anesth Analg 2003; 96:548-554.
Peyton PJ, Rigg JRA, Jamrozik K, Myles PS, Silbert BS, Parsons RW. The MASTER Trial has successfully addressed requirements of protocols for large trials. Anesth Analg 2003; 97:922-923.;
The full abstract can be viewed on Pubmed