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Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.
The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.
Details
| Lead sponsor | American Hip Institute |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 107 |
| Start date | 2014-04 |
| Completion | 2016-03 |
Conditions
- Pain, Postoperative
Interventions
- Liposomal Bupivacaine
- 0.25% Bupivacaine with epinephrine
- Saline
Primary outcomes
- Patient Morphine Equivalent Consumption — 72 hours postoperation, divided into six 12-hour periods
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams. - Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score — 72 hours post-operation, divided into six 12-hour periods
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval. - Time to Ambulation More Than 20 Feet (in Hours) — from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded. - Length of Stay (LOS, in Days) — From time of surgery until patient is discharged, an average of 1.5 days.
- Number of Patients That Experienced a Fall — 72 hours postoperation
Countries
United States