Status:
RECRUITING
Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Lead Sponsor:
Yale University
Collaborating Sponsors:
Department of Anesthesiology Faculty Development Fund
Conditions:
Total Knee Replacement
Knee Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This phase 2, double blinded and randomized clinical trial will investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivac...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Exclusion
- 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
Key Trial Info
Start Date :
September 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05279092
Start Date
September 8 2022
End Date
March 1 2028
Last Update
May 14 2025
Active Locations (2)
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1
Yale New Haven Hospital Saint Raphael Campus
New Haven, Connecticut, United States, 06520
2
Yale New Haven Hospital York Street Campus
New Haven, Connecticut, United States, 06520