ZYNRELEF for Pain Management in Total Knee Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	35 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural Terminology Code: 27447] 2. Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12] 3. Varus deformity less than 10 degrees. 4. Flexion contracture less than 10 degrees. 5. Age 35

- 70 years old.

6. BMI < 40. 7. Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure.

Exclusion Criteria:

1. Inflammatory arthritis. 2. Post-traumatic arthritis. 3. Valgus deformity. 4. Severe varus (> 10 degrees) 5. Severe flexion contracture (> 10 degrees) 6. Overnight or longer hospital stay after surgery. 7. Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair. 8. Creatinine > 1.2. 9. Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease. 10. Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%) 11. Current liver disease. 12. Personal history of depression or anxiety disorder. 13. Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE) 14. Narcotic or tramadol use within 2 weeks of the planned procedure. 15. Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics. 16. Walking aid for anything other than the operative joint. 17. Contraindication for use of the study drug (as specified by the manufacturer):

- Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components.

- History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs.

18. Patients taking the following medications:

- Amitriptyline.

- Nortriptyline.

- Gabapentin.

- Pregabalin.

- Duloxetine (SNRI) - Des-Venlafaxine (SNRI) - Cyclobenzaprine.

- Baclofen.

19. Pregnant or lactating females. 20. Patients unable to provide informed consent. 21. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05644496
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Baptist Health South Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Juan C Suarez, MD
Principal Investigator Affiliation	Baptist Health South Florida
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Post Operative Pain, Osteoarthritis, Knee

Arms & Interventions

Arms

Experimental: Intervention

In addition to the standard-of-care arm description, single administration of Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release in the surgical site before complete wound closure.

No Intervention: Standard-of-care

Usual standard of care procedure for knee replacement and pain management before, during and immediately following surgery.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Doctors Hospital, Miami, Florida

Status

Recruiting

Address

Doctors Hospital

Miami, Florida, 33146

Site Contact

Yvette Hernandez

[email protected]

786-308-2217

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