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RECRUITING
NCT05644496
PHASE4

ZYNRELEF for Pain Management in Total Knee Arthroplasty

Sponsor: Baptist Health South Florida

View on ClinicalTrials.gov

Summary

The goal of this randomized controlled trial is to compare opioid medication consumption after surgery for patients who have a total knee replacement. The main questions it aims to answer are: * How well does the study drug control pain in the days after surgery? * Does the study drug reduce the amount of opioid analgesic consumed after surgery? Participants in the study group will undergo a total knee replacement as planned with their surgeon. In addition, be given the study drug, Zynrelef (combination of bupivacaine and meloxicam). Researchers will compare the above to a control group who will have a total knee replace only according to usual standards to see if there are any differences in the amount of a type of pain medication (opioid analgesic) consumed in the days following surgery.

Official title: A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty

Key Details

Gender

All

Age Range

35 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

242

Start Date

2023-03-09

Completion Date

2027-12

Last Updated

2025-04-18

Healthy Volunteers

No

Interventions

DRUG

Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release

Instillation of the drug into the knee joint capsule and surrounding tissues after placing the knee prosthesis and before close of the surgical wound

Locations (1)

Doctors Hospital

Miami, Florida, United States