N/A
N=211
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
Osteoarthritis, Knee · Osteoarthritis, Hip · Osteoarthritis, Shoulder
Bottom Line
View on ClinicalTrials.gov: NCT02197273 ↗Enrolled (actual)
211
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Length of Stay in Hospital (Days) — 2.0; 2.0 days — p=0.764
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liposomal bupivacaine (Drug); Standard of care analgesia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OhioHealth
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay in Hospital (Days) |
2.0; 2.0 | 0.764 |
| SECONDARY Time to Post-operative Rescue Opioids (Hours) |
7.7; 11.8 | 0.206 |
| SECONDARY Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days |
2; 4 | 0.656 |
Summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
Exclusion Criteria
- Age 1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with severe hepatic disease
- Patients with chronic heart disease as defined as a decreased ejection fraction
Data sourced from ClinicalTrials.gov (NCT02197273). 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.