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ZYNRELEF for Pain Management in Total Knee Arthroplasty

NCT05644496 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-04-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Baptist Health South Florida

    lead OTHER

Principal Investigators

  • Juan C Suarez, MD · Baptist Health South Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-09
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05644496 on ClinicalTrials.gov