Last reviewed · How we verify
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 (IMPROVE-IR)
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.
Details
| Lead sponsor | Pacira Pharmaceuticals, Inc |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 47 |
| Start date | 2012-03 |
| Completion | 2012-10 |
Conditions
- Retraction of Colostomy
Interventions
- Group 1 Standard of Care
- Group 2 EXPAREL
Primary outcomes
- Total Opioid Burden — Wound closure to time hospital discharge order is written or Day 30, whichever is sooner
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner. - Health Economic Benefits — Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner. - Health Economic Benefit — Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
Countries
United States