Protocol for a prospective single-arm feasibility study of suzetrigine for postoperative pain management in outpatient facial plastic surgery
Abstract
Despite relatively brief postoperative pain courses and well-established risks of adverse effects and dependency, opioid analgesics remain routinely prescribed following outpatient facial plastic surgery. Suzetrigine (Journavx) is a first-in-class, oral, non-opioid analgesic that selectively inhibits the voltage-gated sodium channel 1.8 (NaV1.8), a peripheral nociceptive pathway target that may avoid central nervous system adverse effects associated with opioids. While suzetrigine has demonstrated efficacy in phase III trials of acute postoperative pain, its use in facial plastic surgery has not been studied. This prospective, single-arm feasibility study will evaluate the practicality of incorporating suzetrigine into multimodal postoperative analgesia regimens of adults undergoing outpatient facial plastic surgery. Primary feasibility outcomes include recruitment rate, treatment adherence, and compliance with postoperative pain reporting. Prespecified feasibility benchmarks include recruitment of at least 60% of eligible patients approached for participation, treatment adherence in at least 80% of enrolled participants, and postoperative pain questionnaire completion in at least 70% of participants. Exploratory clinical outcomes include opioid utilization during the first postoperative week, postoperative pain intensity, functional recovery, patient satisfaction, and incidence of adverse events. Findings from this study will provide preliminary data to inform the design of…
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