ALVIMOPAN FOR TREATMENT OF ILEUS Essay Example | Topics and Well Written Essays - 750 words

ALVIMOPAN FOR TREATMENT OF ILEUS - Essay Example alvimopan is a peripherally restricted opiod antagonist, whose use is a strategy aimed at reducing the delay in the GI tract recovery and postoperative morbidity, as a result of the use of opioid analgesia. Ludwig et al, 2008 conducted a study comparing alvimopan or a placebo with the Standardized Accelerated Postoperative Care Pathway (SAPCP). The purpose of the study was to evaluate the efficacy and safety of alvimopan in dosage of 12 mg initially given orally 30 to 90 minutes prior to the surgical procedure and subsequently twice daily along with the SAPCP in the management of POI after bowel resection. This study was a randomized, multi-center, double-blind, placebo controlled phase 3b trial that was conducted across fifty-five sites in the United States of America after receiving the institutional review board approval for each of the sites. Adult patients over the age of eighteen years undergoing laparotomy for small-or large-bowel resection having primary anastomosis and scheduled for post-operative pain management employing opioid-based, patient-controlled analgesia were included for the study. The exclusion criteria consisted of pregnancy, current use of opioids or receiving acute course of opioids less than one week prior to entry into study, experience of complete bowel obstruction, or were undergoing total colectomy, colostomy, ileostomy, or ileal pouch-anal anastomosis, or had a history of total colectomy, gastrectomy, gastric bypass, short bowel syndrome, or multiple previous abdominal operations performed by laparatomy. 654 subjects were recruited and 629 selected for the trial. 325 of the subjects received placebo and SAPCP, while 329 of the subjects received alvimopan and SAPCP. The primary endpoint chosen was the time to GI-2 recovery, which would demonstrated the time taken to resolution of POI. Composite assessment was used to measure toleration of food and lower GI tract recovery. Secondary