drugset / Trial / NCT05644496

ZYNRELEF for Pain Management in Total Knee Arthroplasty

NCT05644496

Phase 4 Terminated 29 enrolled Baptist Health South Florida
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-03-09
Primary completion
2025-12-19
Completion
2025-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 400 mg Other
Subject Meloxicam Small molecule 12 mg Other

Indications