Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Locations
United States
Connecticut
Yale New Haven Hospital Saint Raphael Campus
RECRUITING
New Haven
Yale New Haven Hospital York Street Campus
RECRUITING
New Haven
Contact Information
Primary
Jinlei Li, MD PhD
jinlei.li@yale.edu
475-434-4038
Time Frame
Start Date: 2023-02-07
Estimated Completion Date: 2028-03
Participants
Target number of participants: 66
Treatments
Experimental: B-LB in left knee and B-DEX-MPA in right knee
Participants in this arm will receive B-LB in their left knee and B-DEX-MPA in their right knee.~Nerve block with (B-LB): 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.~Nerve block with (B-DEX-MPA): 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.
Experimental: B-LB in right knee and B-DEX-MPA in left knee
Participants in this arm will receive B-LB in their right knee and B-DEX-MPA in their left knee.~Nerve block with (B-LB): 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.~Nerve block with (B-DEX-MPA): 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.
Related Therapeutic Areas
Sponsors
Collaborators: Department of Anesthesiology Faculty Development Fund
Leads: Yale University