Epidural-General Anesthesia or General Anesthesia in Reducing Complications and Improving Survival in Patients Undergoing Pancreaticoduodenectomy

PRIMARY OBJECTIVE:

I. To determine if intraoperative epidural-general anesthesia plus post-operative epidural analgesia (EG) decreases the incidence of grade 3 or greater complications in adult patients undergoing pancreaticoduodenectomy (PD), as compared to general anesthesia with epidural for post operation (op) analgesia (GA).

SECONDARY OBJECTIVES:

I. To determine if EG improves 2-year survival in adult patients undergoing pancreaticoduodenectomy (PD) for adenocarcinoma as compared to GA.

II. To determine if EG results in decreased length of stay (LOS) in patients undergoing pancreaticoduodenectomy as compared to GA.

EXPLORATORY OBJECTIVE:

I. To determine if EG decreases the incidence of post operative delirium as compared to GA.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive bupivacaine hydrochloride and fentanyl via epidural catheter before pancreaticoduodenectomy. Patients also receive propofol intravenously (IV), rocuronium or vecuronium IV, and fentanyl IV before pancreaticoduodenectomy. Patients continue to receive bupivacaine hydrochloride and fentanyl via epidural catheter after completion of pancreaticoduodenectomy.

ARM II: Patients receive propofol IV, rocuronium or vecuronium IV, and fentanyl IV before pancreaticoduodenectomy. Patients then receive bupivacaine hydrochloride and fentanyl via epidural catheter after completion of pancreaticoduodenectomy.

After completion of study treatment patients are followed up for at least 2 years.