RECRUITING

ZYNRELEF for Pain Management in Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-09
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05644496

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.

Ages Eligible for Study:35 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult patients undergoing primary unilateral total knee arthroplasty \[Current Procedural Terminology Code: 27447\]
  2. 2. Patients with a diagnosis of primary osteoarthritis \[ICD-10 codes: M17.0, M17.10, M17.11, M17.12\]
  3. 3. Varus deformity less than 10 degrees
  4. 4. Flexion contracture less than 10 degrees
  5. 5. Age 35 - 70 years old
  6. 6. BMI \< 40
  7. 7. Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure
  1. 1. Inflammatory arthritis
  2. 2. Post-traumatic arthritis
  3. 3. Valgus deformity
  4. 4. Severe varus (\> 10 degrees)
  5. 5. Severe flexion contracture (\> 10 degrees)
  6. 6. Overnight or longer hospital stay after surgery
  7. 7. Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair
  8. 8. Creatinine \> 1.2
  9. 9. Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease
  10. 10. Uncontrolled Diabetes mellitus (Glycated Hemoglobin \> 8.0%)
  11. 11. Current liver disease
  12. 12. Personal history of depression or anxiety disorder
  13. 13. Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)
  14. 14. Narcotic or tramadol use within 2 weeks of the planned procedure
  15. 15. Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics
  16. 16. Walking aid for anything other than the operative joint
  17. 17. Contraindication for use of the study drug (as specified by the manufacturer):
  18. * Known hypersensitivity to local amide anesthetics, NSAIDs or study drug components
  19. * History of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDs
  20. 18. Patients taking the following medications:
  21. * Amitriptyline
  22. * Nortriptyline
  23. * Gabapentin
  24. * Pregabalin
  25. * Duloxetine (SNRI)
  26. * Des-Venlafaxine (SNRI)
  27. * Cyclobenzaprine
  28. * Baclofen
  29. 19. Pregnant or lactating females
  30. 20. Patients unable to provide informed consent
  31. 21. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Contacts and Locations

Study Contact

Yvette Hernandez
CONTACT
786-308-2217
yvettesal@baptisthealth.net
Chukwuemeka Osondu
CONTACT
786-308-2011
emekao@baptisthealth.net

Principal Investigator

Juan C Suarez, MD
PRINCIPAL_INVESTIGATOR
Baptist Health South Florida

Study Locations (Sites)

Doctors Hospital
Miami, Florida, 33146
United States

Collaborators and Investigators

Sponsor: Baptist Health South Florida

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2026-04

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Knee Arthroplasty
  • Postoperative pain management

Additional Relevant MeSH Terms

  • Post Operative Pain
  • Osteoarthritis, Knee