NCT05736549

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral 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.

Detailed description

This phase 2 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 bilateral total knee arthroplasty (TKA). The primary objective of this 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 bilateral 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). An anticipated 66 participants who are scheduled for primary, elective bilateral TKA will be enrolled.

Conditions

• Total Knee Replacement
• Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	Bupivacaine-Liposomal Bupivacaine	A medication mixture of 40 ml (20 ml LB and 20 ml 0.25% plain bupivacaine) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.
DRUG	Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate	A medication mixture of 40 ml (40 ml 0.25% plain bupivacaine, 10 mg DEX and 80 mg MPA) will be prepared, of which 20 ml will be used in Adductor canal block, 10 ml will be used in iPACK block and 5 ml each will be used in medial upper and lateral upper genicular nerve block, respectively.

Timeline

• Start date: 2023-02-07
• Primary completion: 2027-09-01
• Completion: 2028-03-01
• First posted: 2023-02-21
• Last updated: 2025-05-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study