A Randomized Controlled Trial of ZYNRELEF Versus Standard of Care for Pain Management Following Unilateral Total Knee Arthroplasty
Baptist Health South Florida
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.
Eligibility
- Age range
- 35–70 years
- Sex
- All
- Healthy volunteers
- No
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. Se…
Interventions
- DrugBupivacaine-Meloxicam 400 Mg-12 Mg/14 mL Injectable Solution, Extended Release
Instillation of the drug into the knee joint capsule and surrounding tissues after placing the knee prosthesis and before close of the surgical wound
Location
- Doctors HospitalMiami, Florida