NCT05644496

ZYNRELEF for Pain Management in Total Knee Arthroplasty

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Operative Pain
• Osteoarthritis, Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-03-09
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2022-12-09
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study