The goal of this prospective is to determinate if Suzetrigine decreased de use of opioids in patients that undergo an arthroscopic rotator cuff repair. The main question it aims to answer:
Does Suzetrigine lower the number of times participants need to use opioid?
If there is a comparison group: Researchers will compare study drug group to see if, will reduce opioid utilization during the inpatient period and at discharge without worsening pain control, compared with multimodal analgesia alone.
Participants will take study drug before procedure and for 13 days afterwards.
Adults aged 18 years or older
BMI 18-45 kg/m2
ASA Physical Status Classification I-IV
Scheduled to undergo outpatient primary arthroscopic rotator cuff repair under general anesthesia with performance of a single-shot interscalene nerve block preoperatively
• Known history of opioid use disorder, aberrant opioid use, or substance use disorder within the past 3 years; or positive preoperative drug screen inconsistent with prescribed medications
Chronic opioid use >10 MME/day based on PDMP average over the preceding 30 days; current use of buprenorphine or methadone
Known allergy or significant adverse reaction to suzetrigine, opioids, NSAIDs, or acetaminophen
Hepatic impairment Child-Pugh Class B or C (contraindication to suzetrigine)
Parallel
Suzetrigine (Journavx)
DrugOral NaV1.8 inhibitor. Loading dose 100mg administered preoperatively, followed 12 hours later by 50mg orally every 12 hours for 13.5 days post-discharge.
Matching placebo
DrugPlacebo tablets identical in appearance, size, and packaging to suzetrigine tablets. Administered on the same schedule as suzetrigine.
Standard multimodal analgesia
DrugAcetaminophen 1000mg three times daily, gabapentin 100mg three times daily, methocarbamol 750mg three times daily, and oxycodone 5mg every 4-6 hours as needed for pain.
Inpatient Morphine Milligram Equivalent (MME)
Cumulative opioid utilization in morphine milligram equivalent (MME) from PACU arrival through hospital discharge, obtained via medication administration record review
Outpatient Opioid Utilization
Total Morphine Milligram Equivalent (MME) based on patient reported oxycodone use via twice-daily questionnaire
Pain Interference
Degree to which pain interferes with daily activities, assessed using the Brief Pain Inventory (BPI) Pain Interference subscale (7 items, 0-10 scale). Higher scores indicate greater interference.
Pain During Most Painful Activity (Numeric Rating Scale)
Patient-reported pain during most painful activity of the day, assessed via numeric rating scale (0-10; higher scores indicate greater pain)
Incidence of Postoperative Nausea and Vomiting (PONV)
Antiemetic requirement - chart review + survey
Incidence of Constipation
Patient-reported constipation symptoms via daily questionnaire (yes/no)
Feasibility - Enrollment
Percentage of eligible patients enrolled in the study
Feasibility - Study Drug Adherence
Percentage of days with at least one study drug dose taken (suzetrigine or placebo), assessed in both arms
Feasibility - Questionnaire Data Capture
Percentage of scheduled questionnaire entries completed by participants in both arms
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