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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 | 33 |
| Start date | 2012-01 |
| Completion | 2012-10 |
Conditions
- Retraction of Colostomy
Interventions
- IV morphine sulfate or Sponsor-approved equivalent
- EXPAREL
Primary outcomes
- Total Opioid Burden — Wound closure to time the 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 - Total Cost of Hospitalization — Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
1\) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. - Health Economic Benefit - Length of Stay — Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner
Countries
United States