Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Recruiting now · Phase 2
Conditions studied: Total Knee Replacement, Knee Arthroplasty
In brief
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 facts
- Study ID
- NCT05279092
- Run by
- Yale University
- People needed
- 250
- Starts
- 2022-09-08
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
You may not qualify if…
- Refusal of consent
- Pregnancy
- Conditions making the patient unable to fill out questionnaire online, through email or over the phone including with cognitive dysfunction, psychiatric disorder, or non-English speaking patients, or lack of internet access which would prevent post discharge follow-up electronically
- Coagulopathy
- Allergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LB
- Patients on any amounts of opioids within one month of the surgery date, any substance abuse such as regular marijuana user (more frequent than once per month)
- Insulin dependent or uncontrolled diabetes defined as, day of surgery finger stick glucose >200mg/dl, or HbA1C > 8.0%
- Peripheral Nerve Block site or systemic infection
- Immune compromise (e.g., HIV, chronic glucocorticoid use)
- Severe pre-existing neuropathy
- TKA for indications other than osteoarthritis such as post-traumatic injury or rheumatoid arthritis, history of surgery in the ipsilateral knee joint, revision TKA or bilateral TKA
- Severe hepatic or renal dysfunction (GFR <50 ml/min)
- Actual body weight <60 kg
- Patients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis
Where it is running
- Yale New Haven Hospital Saint Raphael Campus — New Haven, Connecticut, United States (enrolling)
- Yale New Haven Hospital York Street Campus — New Haven, Connecticut, United States (enrolling)
Full record on ClinicalTrials.gov
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