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RECRUITING
NCT05279092
PHASE2

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Sponsor: Yale University

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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