Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
American Society of Anesthesiologists status I, II and III, elective, primary, unilateral TKA planned for spinal anesthesia with plain 0.5% bupivacaine.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Bupivacaine-Liposomal Bupivacaine
- Bupivacaine -Dexamethasone Sodium Phosphate-Methylprednisolone Acetate
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Department of Anesthesiology Faculty Development Fund
Collaborator
Source ClinicalTrials.gov