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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 Open Colectomy (IMPROVE-Open)
This study is designed to compare the standard of care against EXPAREL(R) 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 | 42 |
| Start date | 2011-12 |
| Completion | 2012-08 |
Conditions
- Bowel Obstruction
Interventions
- IV morphine sulfate
- EXPAREL (bupivacaine liposome injectable suspension)
Primary outcomes
- Total Opioid Burden — Wound closure to time hospital discharge order written or Day 30, whichever is sooner
Total opioid consumed (IV and PO) postsurgically until the 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 written or Day 30, whichever is sooner.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner. - Health Economic Benefits - Length of Stay — Up to Day 30
Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, 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