Actively Recruiting
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Led by Yale University · Updated on 2025-05-14
250
Participants Needed
2
Research Sites
285 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
D
Department of Anesthesiology Faculty Development Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists status I, II, or III
- Elective, primary, unilateral total knee arthroplasty planned for spinal anesthesia with plain 0.5% bupivacaine
You will not qualify if you...
- Refusal of consent
- Pregnancy
- Inability to complete follow-up questionnaires due to cognitive dysfunction, psychiatric disorder, language barrier, or lack of internet access
- Coagulopathy
- Allergy or intolerance to acetaminophen, Celebrex, bupivacaine, dexamethasone, methylprednisolone acetate, or liposomal bupivacaine
- Use of any opioids within one month before surgery or regular marijuana use more than once per month
- Insulin-dependent or uncontrolled diabetes with day-of-surgery blood glucose >200 mg/dl or HbA1C > 8.0%
- Infection at peripheral nerve block site or systemic infection
- Immune compromise such as HIV or chronic glucocorticoid use
- Severe pre-existing neuropathy
- Total knee arthroplasty for reasons other than osteoarthritis, history of surgery on the same knee, revision or bilateral TKA
- Severe liver or kidney dysfunction with glomerular filtration rate <50 ml/min
- Body weight less than 60 kg
- Active or latent peptic ulcers, diverticulitis, recent intestinal anastomoses, or non-specific ulcerative colitis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Yale New Haven Hospital Saint Raphael Campus
New Haven, Connecticut, United States, 06520
Actively Recruiting
2
Yale New Haven Hospital York Street Campus
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
J
Jinlei Li, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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