Actively Recruiting
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Led by Yale University · Updated on 2025-05-14
66
Participants Needed
2
Research Sites
264 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 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.
CONDITIONS
Official Title
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective, primary, bilateral total knee arthroplasty planned with spinal anesthesia using plain 0.5% bupivacaine
- American Society of Anesthesiologists status I, II, or III
You will not qualify if you...
- Refusal to consent to participate
- Pregnancy
- Unable to complete follow-up questionnaires online, by email, or phone due to cognitive dysfunction, psychiatric disorder, non-English speaking, or lack of internet access
- Coagulopathy
- Allergy or contraindication to acetaminophen, Celebrex, bupivacaine, dexamethasone, methylprednisolone acetate, or liposomal bupivacaine
- Opioid use within one month before surgery or regular marijuana use more than once per month
- Insulin dependent or uncontrolled diabetes (surgery day glucose >200mg/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
- TKA for reasons other than osteoarthritis, history of surgery in the same knee, revision TKA, or bilateral TKA
- Severe liver or kidney dysfunction (GFR <50 ml/min)
- Body weight less than 60 kg
- Active or latent peptic ulcers, diverticulitis, recent intestinal surgery, or non-specific ulcerative colitis
AI-Screening
AI-Powered 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
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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