drugset / Trial / NCT05279092
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Phase 2
Recruiting
250 enrolled
Yale University
Department of Anesthesiology Faculty Development Fund · collab
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.
Timeline
- Start
- 2022-09-08
- Primary completion
- 2027-09
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 133 mg | Other |
| Subject | Dexamethasone | Small molecule | 5 mg | Other |
| Subject | Methylprednisolone | Other / unclassified | 40 mg | Other |
| Comparator | Bupivacaine | Other / unclassified | 0.25 % | Other |