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Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Sponsor: Yale University
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.
Official title: Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2022-09-08
Completion Date
2028-03
Last Updated
2025-05-14
Healthy Volunteers
No
Conditions
Interventions
Bupivacaine-Liposomal Bupivacaine
Adductor canal block comprised of 20 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 30 ml; 10 ml 0.25% plain bupivacaine + 10 ml LB (133 mg) with the total volume of 20 ml will be administered through an iPACK block
Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
Adductor canal block comprised of 30 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml); 20 ml 0.25% plain bupivacaine + 5 mg DEX (0.5 ml) and 40 mg MPA (1 ml) will be administered through an iPACK block.
Locations (2)
Yale New Haven Hospital Saint Raphael Campus
New Haven, Connecticut, United States
Yale New Haven Hospital York Street Campus
New Haven, Connecticut, United States