Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05279092
Phase
PHASE2
Status
Recruiting
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Conditions

  • Knee Arthroplasty
  • Total Knee Replacement

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 8, 2022
Status verified
May 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

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

Arms

  • Active Comparator: Bupivacaine-Liposomal Bupivacaine (B-LB)
    Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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 Interspace between the popliteal artery and capsule of the posterior knee (iPACK) block.
  • Experimental: Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate (B-DEX-MPA)
    Nerve blockade administration will be carried out per standard of care. All patients will receive single injection under ultrasound guidance with 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.

Primary Outcome Measure

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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