Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Recruiting now · Phase 2
Conditions studied: Total Knee Replacement, Knee Arthroplasty
In brief
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 facts
- Study ID
- NCT05736549
- Run by
- Yale University
- People needed
- 66
- Starts
- 2023-02-07
- 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, bilateral 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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