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NCT05644496 | RECRUITING | Post Operative Pain

ZYNRELEF for Pain Management in Total Knee Arthroplasty
Sponsor:

Baptist Health South Florida

Brief 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.

Condition or disease

Post Operative Pain

Osteoarthritis, Knee

Intervention/treatment

Bupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 242 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
Actual Study Start Date : 2023-03-09
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
ZYNRELEF for Pain Management in Total Knee Arthroplasty

Location Details

NCT05644496

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Doctors Hospital

Miami, Florida, United States, 33146