Phase 2
Completed N=107
Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
Pain, Postoperative
Source: ClinicalTrials.gov NCT03001453 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Patient Morphine Equivalent Consumption — 35.1; 50.5; 28.0; 29.6 mg
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Morphine Equivalent Consumption |
35.1; 50.5; 28.0; 29.6; 16.8; 21.0 | — |
| PRIMARY Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score |
3.8; 3.7 | — |
| PRIMARY Time to Ambulation More Than 20 Feet (in Hours) |
10.9; 14.0 | — |
| PRIMARY Length of Stay (LOS, in Days) |
46.0; 44.4 | — |
| PRIMARY Number of Patients That Experienced a Fall |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo primary unilateral total hip replacement
- Patients diagnosed with hip osteoarthritis
- Patients failed to improve with conservative measures
- Patients willing and able to sign informed consent
Exclusion Criteria
- Revision total hip replacement
- Bilateral total hip replacement
- Birmingham hip resurfacing
- Patients with hepatic/kidney disease
- Patients with a known allergy to bupivacaine or other local anesthetics
Data sourced from ClinicalTrials.gov (NCT03001453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.