ZYNRELEF for Pain Management in Total Knee Arthroplasty

Stopped early · Phase 4

Conditions studied: Post Operative Pain, Osteoarthritis, Knee

In brief

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.

Key facts

Study ID

NCT05644496

Run by

Baptist Health South Florida

People needed

29

Starts

2023-03-09

Expected to finish

2025-12-19

Last updated by the study team

2026-05-28

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients undergoing primary unilateral total knee arthroplasty [Current Procedural Terminology Code: 27447]
• Patients with a diagnosis of primary osteoarthritis [ICD-10 codes: M17.0, M17.10, M17.11, M17.12]
• Varus deformity less than 10 degrees
• Flexion contracture less than 10 degrees
• Age 35 - 70 years old
• BMI < 40
• Patients who are discharged on the same day after the unilateral total knee arthroplasty procedure

You may not qualify if…

• Inflammatory arthritis
• Post-traumatic arthritis
• Valgus deformity
• Severe varus (> 10 degrees)
• Severe flexion contracture (> 10 degrees)
• Overnight or longer hospital stay after surgery
• Prior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repair
• Creatinine > 1.2
• Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal disease
• Uncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%)
• Current liver disease
• Personal history of depression or anxiety disorder
• Personal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)
• Narcotic or tramadol use within 2 weeks of the planned procedure
• Allergy to aspirin, NSAIDS, oxycodone, Tylenol, local anesthetics
• Walking aid for anything other than the operative joint
• 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
• Patients taking the following medications:
• Amitriptyline
• Nortriptyline
• Gabapentin
• Pregabalin
• Duloxetine (SNRI)

Where it is running

• Doctors Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.