Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This phase 2, double blinded and randomized clinical trial will 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). The primary 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 total knee arthroplasty (TKA). The secondary objective of this study is to test the effects of perineural use of B-DEX-MPA vs B-LB on the quality of postoperative recovery as well as surgical outcome and neuropathic pain among patients undergoing unilateral TKA. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB. This will be a single center study at Yale New Haven Hospital (YNHH) performed at two clinical sites: York St. Campus (York Street, New Haven) and St. Raphael Campus (Chapel Street, New Haven). 250 primary, elective and unilateral TKA patients will be enrolled, and equally randomized (1:1 ratio) to receive peripheral nerve blockade with B- LB or B-DEX-MPA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05279092
Study type	Interventional
Source	Yale University
Contact	Jinlei Li, MD PhD
Phone	475-434-4038
Email	jinlei.li@yale.edu
Status	Recruiting
Phase	Phase 2
Start date	September 8, 2022
Completion date	March 2026

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study — Yale SEVEN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms