ZYNRELEF for Pain Management in Total Knee Arthroplasty

Launched by BAPTIST HEALTH SOUTH FLORIDA · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new pain management drug called Zynrelef, which is a combination of two medications, bupivacaine and meloxicam. The main goal is to see how well Zynrelef controls pain after patients undergo total knee replacement surgery and whether it helps reduce the amount of opioid pain medication they need in the days following the surgery. This is important because opioids can have side effects and are often overused for pain relief.

To participate in this trial, you must be an adult between the ages of 35 and 70 who is having a total knee replacement due to osteoarthritis. You should be in generally good health, with no significant complications or other medical conditions that might affect your surgery or recovery. If you qualify and decide to participate, you will receive either Zynrelef or standard care during your surgery. Researchers will then compare your recovery and pain management outcomes with those of other participants who do not receive the study drug. This trial is currently recruiting participants, so if you or someone you know is interested, it could be a good opportunity to help advance pain management after knee surgery.

Gender

ALL

Eligibility 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 Officials