Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Patients undergoing major abdominal surgery are at highest risk for developing postoperative
 ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal
 distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or
 inability to pass flatus or stool; and inability to tolerate a solid diet. This study will
 test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of
 surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery
 (bowel resection or abdominal hysterectomy).
Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a
 slowing down of movement of contents of the intestines. This functional impairment persists
 for a variable duration following surgery, usually resolving within 1 day in the small
 intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for
 more than 5 days, it is generally considered severe, sometimes referred to as complicated or
 prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown
 to consistently shorten the duration of POI. This study is designed to demonstrate that
 alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the
 recovery of GI function in patients undergoing bowel resection of hysterectomy.
Inclusion Criteria:

 -  Subject is scheduled for a partial small/large bowel resection of primary anastomosis
 or total abdominal hysterectomy (simple or radical) via laparotomy

 -  Subject is scheduled to receive primary postoperative pain management with intravenous
 (i.v.) patient-controlled analgesia (PCA) opioids

 Exclusion Criteria:

 -  Subject is scheduled for a total colectomy, colostomy, ileostomy

 -  Subject has complete bowel obstruction

 -  Subject is currently taking opioid analgesics or has taken opioid analgesics within
 the prior 2 weeks