NCT01509638

A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of Bupivacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Conditions

• Retraction of Colostomy

Interventions

Type	Name	Description
DRUG	Group 1 Standard of Care	Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
DRUG	Group 2 EXPAREL	Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-01-13
• Last updated: 2014-03-06
• Results posted: 2014-03-06

Locations

2 sites across 1 country: United States