University of California, Irvine
This proposal seeks to determine if the addition of Suzetrigine, a novel non-opioid pain medication, to a standardized multimodal pain management pathway significantly reduces total postoperative opioid consumption (measured in Morphine Milligram Equivalents \[MME\]) and improves patient-reported pain scores during the first 14 days following primary total knee arthroplasty (TKA). Prior to conducting a definitive randomized control trial (RCT), we propose a pilot study to inform the trial's design and feasibility. Objective: To inform the design and feasibility of a definitive RCT comparing postoperative pain control with and without Suzetrigine after TKA. To achieve this objective, we will conduct a pilot trial and address the following aims: 1\) to determine if participant enrollment is feasible, 2) to assess compliance with treatment protocol and key aspects of the protocol, and 3) to refine data collection methods.
Inclusion Criteria: * Adults aged 18 to 80 years * Diagnosis of knee osteoarthritis * Scheduled for unilateral TKA * Willingness to maintain a 14-day medication and pain log Exclusion Criteria: * Chronic opioid use * Severe renal impairment (eGFR \< 30 mL/min) or severe hepatic impairment (Child-Pugh Class C) * History of active peptic ulcer disease or GI bleeding * Known allergies to any of the study medications (suzetrigine, acetaminophen, meloxicam, or oxycodone). * Significant peripheral neuropathy in the operative extremity * Active history of substance abuse or opioid use disorder
100 mg loading dose of Suzetrigine, followed by 50mg every 12 hours for 14 days as an addition to a standardized multimodal pain management pathway.
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