 CLINICAL INVESTIGATIONS Anesthesiology 2001; 95:1054 – 67 © 2001 American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins, Inc. Double-masked Randomized Trial Comparing Alternate Combinations of Intraoperative Anesthesia and Postoperative Analgesia in Abdominal Aortic Surgery Edward J. Norris, M.D., M.B.A.,* Charles Beattie, M.D., Ph.D.,† Bruce A. Perler, M.D.‡ Elizabeth A. Martinez, M.D.,§ Curtis L. Meinert, Ph.D., Gerald F. Anderson, Ph.D.,# Jeffrey A. Grass, M.D.,** Neil T. Sakima, M.D.,§ Randolph Gorman, M.D.,†† Stephen C. Achuff, M.D.,‡‡ Barbara K. Martin, Ph.D.,§§ Stanley L. Minken, M.D., G. Melville Williams, M.D.,‡ Richard J. Traystman, Ph.D.## Background: Improvement in patient outcome and reduced use of medical resources may result from using epidural anes- thesia and analgesia as compared with general anesthesia and intravenous opioids, although the relative importance of intra- operative versus postoperative technique has not been studied. This prospective, double-masked, randomized clinical trial was designed to compare alternate combinations of intraoperative anesthesia and postoperative analgesia with respect to postop- erative outcomes in patients undergoing surgery of the abdom- inal aorta. Methods: One hundred sixty-eight patients undergoing sur- gery of the abdominal aorta were randomly assigned to receive either thoracic epidural anesthesia combined with a light gen- eral anesthesia or general anesthesia alone intraoperatively and either intravenous or epidural patient-controlled analgesia postoperatively (four treatment groups). Patient-controlled an- algesia was continued for at least 72 h. Protocols were used to standardize perioperative medical management and to preserve masking intraoperatively and postoperatively. A uniform sur- veillance strategy was used for the identification of prospec- tively defined postoperative complications. Outcome evaluation included postoperative hospital length of stay, direct medical costs, selected postoperative morbidities, and postoperative re- covery milestones. Results: Length of stay and direct medical costs for patients surviving to discharge were similar among the four treatment groups. Postoperative outcomes were similar among the four treatment groups with respect to death, myocardial infarction, myocardial ischemia, reoperation, pneumonia, and renal fail- ure. Epidural patient-controlled analgesia was associated with a significantly shorter time to extubation (P  0.002). Times to intensive care unit discharge, ward admission, first bowel sounds, first flatus, tolerating clear liquids, tolerating regular diet, and independent ambulation were similar among the four treatment groups. Postoperative pain scores were also similar among the four treatment groups. Conclusions: In patients undergoing surgery of the abdomi- nal aorta, thoracic epidural anesthesia combined with a light general anesthesia and followed by either intravenous or epi- dural patient-controlled analgesia, offers no major advantage or disadvantage when compared with general anesthesia alone followed by either intravenous or epidural patient-controlled analgesia. THE most appropriate regimen of intraoperative anes- thesia and postoperative analgesia for high-risk patients undergoing major vascular surgery is controversial. Dur- ing the last decade, competing concerns regarding both the quality and the escalating costs of perioperative care have challenged clinicians to establish practice standards that are both safe and efficient. 1 Postoperative compli- cations after moderate-risk elective surgery are com- mon 2 and adversely impact clinical outcome, postoper- ative hospital length of stay (LOS), and resource use. 3 Improvement in outcome and reduced use of medical resources in patients undergoing major vascular proce- dures may result from using epidural anesthesia and analgesia as compared with general anesthesia (GA) alone followed by intravenous opioid. 4,5 Investigations that support or refute such findings have suffered from deficiencies of design and methodology, including non- uniform patient population, 4,5 lack of standardization or control of perioperative treatments, 4 –10 use of non- equivalent modalities for postoperative pain relief, 4 –7,10 and possible investigator bias. 4 –12 Bias is particularly difficult to avoid in clinical investigations of anesthetic techniques because management of perioperative phys- iologic changes and conduct of the technique itself have broad interclinician and intergroup variability. Clearly, masking of treating physicians to technique is a major challenge. At this time, it remains unknown whether regional anesthesia (alone or combined with GA) or analgesia offer any benefit in terms of improved patient outcome or reduced use of medical resources after vas- cular surgery. Furthermore, if regional techniques are in This article is accompanied by an Editorial View. Please see: Todd MM: Clinical research manuscripts in ANESTHESIOLOGY. ANESTHESIOLOGY 2001; 95:1051–3.  * Associate Professor, § Assistant Professor, ## Professor, Department of Anesthesiology and Critical Care Medicine, ‡ Professor,  Associate Professor, Department of Surgery, # Professor, Health Policy Management, ‡‡ Pro- fessor, Department of Medicine, The Johns Hopkins Medical Institutions. † Pro- fessor, Department of Anesthesiology, Vanderbilt University, Nashville, Tennes- see.  Professor, Departments of Epidemiology and Biostatistics, §§ Assistant Professor, Department of Epidemiology, The Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland. ** Chairman, Department of Anesthesiology, Western Pennsylvania Hospital, Pittsburgh, Pennsylva- nia. †† Staff Anesthesiologist, Greater Baltimore Medical Center, Baltimore, Maryland. Received from the Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Medical Institutions, Baltimore, Maryland. Submitted for publication December 27, 2000. Accepted for publication May 25, 2001. Supported by grant No. GM 38177-08 from the National Institutes of Health, Bethesda, Maryland. Presented in part at the annual meeting of the Society of Cardiovascular Anesthesiologists, Chicago, Illinois, April 27, 1999. Address reprint requests to Dr. Norris: Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins Medical Institutions, 600 North Wolfe Street, Tower 711, Baltimore, Maryland 21287-8711. Address electronic mail to: enorris@jhmi.edu. Individual article reprints may be purchased through the Journal Web site, www.anesthesiology.org. Anesthesiology, V 95, No 5, Nov 2001 1054 Downloaded from http://pubs.asahq.org/anesthesiology/article-pdf/95/5/1054/332797/0000542-200111000-00006.pdf by guest on 17 December 2021