Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05736549
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Knee Arthroplasty
  • Total Knee Replacement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine-Liposomal Bupivacaine — DRUG
    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.
  • Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 7, 2023
Status verified
May 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Change in Postoperative Knee Pain Score [ Time Frame: Day 1 and Day 2 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven Hospital Saint Raphael CampusNew HavenConnecticut06520
Jinlei Li, MD PhD
[email protected]
475-434-4038
Yale New Haven Hospital York Street CampusNew HavenConnecticut06520
Jinlei Li, MD PhD
[email protected]
475-434-4038

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By research site
Yale New Haven Hospital Saint Raphael Campus· New Haven, CTYale New Haven Hospital York Street Campus· New Haven, CT

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