A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B302

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pacira Pharmaceuticals, Inc
• Collaborator: Registrat-Mapi
• Treatments: Bupivacaine; Morphine

Criteria

Inclusion Criteria:

• Male or female, 18 years of age or older.

• Patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.

• Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

• Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.

• Patients who abuse alcohol or other drug substance.

• Patients with severe hepatic impairment.

• Patients currently pregnant or who may become pregnant during the course of the study.

• Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.

• Patients who have participated in a EXPAREL study within the last 30 days.

• Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

• Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

• Patients with unplanned multiple segmental resections or large intestine.

• Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.

• Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or an other analgesic, local anesthetics, or anti-inflammatory agents.

• Patients who receive Entereg(R).