ZYNRELEF for Pain Management in Total Knee Arthroplasty

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.

Inclusion Criteria: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 degreesFlexion contracture less than 10 degreesAge 35 - 70 years oldBMI < 40Patients who are discharged on the same day after the unilateral total knee arthroplasty procedureExclusion Criteria:Inflammatory arthritisPost-traumatic arthritisValgus deformitySevere varus (> 10 degrees)Severe flexion contracture (> 10 degrees)Overnight or longer hospital stay after surgeryPrior surgery on affected knee other than knee arthroscopy for meniscal or cartilage debridement/repairCreatinine > 1.2Chronic Kidney Disease (CKD) stage 3, 4, 5 or end stage renal diseaseUncontrolled Diabetes mellitus (Glycated Hemoglobin > 8.0%)Current liver diseasePersonal history of depression or anxiety disorderPersonal history of Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE)Narcotic or tramadol use within 2 weeks of the planned procedureAllergy to aspirin, NSAIDS, oxycodone, Tylenol, local anestheticsWalking aid for anything other than the operative jointContraindication for use of the study drug (as specified by the manufacturer):Known hypersensitivity to local amide anesthetics, NSAIDs or study drug componentsHistory of asthma, urticaria or other allergic-type reactions to aspirin or other NSAIDsPatients taking the following medications:AmitriptylineNortriptylineGabapentinPregabalinDuloxetine (SNRI)Des-Venlafaxine (SNRI)CyclobenzaprineBaclofenPregnant or lactating femalesPatients unable to provide informed consentSubjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures