← Back to all trials
Recruiting
NCT05736549
Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Conditions: Total Knee Replacement, Knee Arthroplasty
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 66
Sponsor: Yale University
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:American Society of Anesthesiologists status I, II and III, elective, primary, bilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.Exclusion Criteria:Refusal of consentPregnancyConditions 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 electronicallyCoagulopathyAllergy to or for any other reasons cannot use Acetaminophen, Celebrex, local anesthetic bupivacaine, DEX, MPA or LBPatients 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 infectionImmune compromise (e.g., HIV, chronic glucocorticoid use)Severe pre-existing neuropathyTKA 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 TKASevere hepatic or renal dysfunction (GFR <50 ml/min)Actual body weight <60 kgPatients with active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis
Source: ClinicalTrials.gov (NCT05736549). StuddyBuddy aggregates publicly available trial information.