ZYNRELEF for Pain Management in Total Knee Arthroplasty

Description

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

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Study Overview

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Study Details

Study overview

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.

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

ZYNRELEF for Pain Management in Total Knee Arthroplasty

Condition
Post Operative Pain
Intervention / Treatment

-

Contacts and Locations

Miami

Doctors Hospital, Miami, Florida, United States, 33146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

35 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baptist Health South Florida,

Juan C Suarez, MD, PRINCIPAL_INVESTIGATOR, Baptist Health South Florida

Study Record Dates

2026-04