Osteoarthritis, Knee, Post Operative Pain
Conditions
Keywords
Knee Arthroplasty, Postoperative pain management
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.
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
Sponsors
Baptist Health South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid analgesic consumption | 5 days following surgical procedure | Amount of opioid analgesic consumed in the time frame calculated as Morphine Milligram Equivalent (MME). |
| Change in pain assessment scores | Baseline and every 24 hours for 120 hours following surgical procedure | Pain assessment scores using the pain Numeric Rating Scale for pain (NRS). The NRS scale is measured on a scale of 0 - 10, where 0 is no pain and 10 is the most severe pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major complications | 42 days following surgical procedure | Number of procedure-related adverse events and medication-related adverse events. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJuan C Suarez, MD
Baptist Health South Florida
Outcome results
None listed