Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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
Qualifiers
American Society of Anesthesiologists status I, II and III, elective, primary, bilateral 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
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Department of Anesthesiology Faculty Development Fund
Collaborator
Source ClinicalTrials.gov