Actively Recruiting
ZYNRELEF for Pain Management in Total Knee Arthroplasty
Led by Baptist Health South Florida · Updated on 2025-04-18
242
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
ZYNRELEF for Pain Management in Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients undergoing primary unilateral total knee arthroplasty
- Diagnosis of primary osteoarthritis of the knee
- Varus deformity less than 10 degrees
- Flexion contracture less than 10 degrees
- Age between 35 and 70 years
- Body mass index (BMI) less than 40
- Discharged on the same day after the knee replacement surgery
You will not qualify if you...
- Inflammatory arthritis
- Post-traumatic arthritis
- Valgus deformity
- Severe varus deformity (greater than 10 degrees)
- Severe flexion contracture (greater than 10 degrees)
- Hospital stay overnight or longer after surgery
- Prior surgery on the affected knee other than arthroscopy for meniscal or cartilage repair
- Creatinine level above 1.2
- Chronic kidney disease stage 3 or higher
- Uncontrolled diabetes (Hemoglobin A1c greater than 8.0%)
- Current liver disease
- History of depression or anxiety disorder
- History of deep vein thrombosis or pulmonary embolism
- Use of narcotics or tramadol within 2 weeks before surgery
- Allergy to aspirin, NSAIDs, oxycodone, Tylenol, or local anesthetics
- Use of walking aids for reasons other than the operative knee
- Contraindications to the study drug such as allergies to local anesthetics or NSAIDs, asthma, or allergic reactions to aspirin
- Use of certain medications including amitriptyline, nortriptyline, gabapentin, pregabalin, duloxetine, desvenlafaxine, cyclobenzaprine, or baclofen
- Pregnant or lactating females
- Unable to give informed consent
- Expected non-compliance with study procedures or schedules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Doctors Hospital
Miami, Florida, United States, 33146
Actively Recruiting
Research Team
Y
Yvette Hernandez
CONTACT
C
Chukwuemeka Osondu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here