Excerpt
Methods: Following institutional approval and written informed consent, 160 consecutive patients presenting for abdominal aortic reconstruction were studied. All patients were monitored with arterial and pulmonary artery catheters and received a T10-T12 epidural catheter. After epidural placement was confirmed by a test dose, patients were randomized to one of four possible treatment combinations: 1) epidural supplemented general anesthesia/epidural PCA (EPI/EPI); 2) epidural supplemented general anesthesia/IV PCA (EPI/IV); 3) general anesthesia/IV PCA (GA/IV); and 4) general anesthesia/epidural PCA (GA/EPI). Each patient received simultaneous IV and epidural boluses/infusions, one of which contained active drug and the other saline according to randomized treatment assignment. All aspects of perioperative anesthetic and medical management were rigorously controlled by protocol. Postoperative PCA was continued for 72 hours and managed by an acute pain service. LOS was calculated using date of surgery and date of discharge. Patients who did not survive to discharge were excluded from analysis. Data were analyzed using linear regression of ranks of LOS and are reported as mean +/- SD and [median].
Results: The results are shown in Table 1. Differences in LOS between the four treatment groups were not statistically significant. Nine patients did not survive to discharge.
Discussion: This is the first double-blind, randomized clinical trial comparing alternate combinations of intraoperative anesthesia and postoperative analgesia in vascular surgery patients. Unique features of this trial include standardization of clinical care throughout the perioperative period, inclusion of all four possible treatment combinations, and patient and treating physicians blinded to treatment assignment. In this high-risk surgical population, we were unable to demonstrate a reduction in the LOS.
Supported by NIH grant GM-38177-06.