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NOT YET RECRUITING

NCT07866638

PHASE4

Suzetrigine for Analgesiain Arthroscopic Rotator Cuff Repair

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating Suzetrigine as an Opioid-Sparing Adjunct to Multimodal Analgesia in Arthroscopic Rotator Cuff Repair

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-11-01

Completion Date

2028-09-01

Last Updated

2026-10-08

Healthy Volunteers

Yes

Conditions

Artroscopic Surgery Pain Management Pain After Shoulder Surgery Opioid Consumption Opioid Consumption, Postoperative

Interventions

DRUG

Suzetrigine (Journavx)

Oral NaV1.8 inhibitor. Loading dose 100mg administered preoperatively, followed 12 hours later by 50mg orally every 12 hours for 13.5 days post-discharge.

DRUG

Matching placebo

Placebo tablets identical in appearance, size, and packaging to suzetrigine tablets. Administered on the same schedule as suzetrigine.

DRUG

Standard multimodal analgesia

Acetaminophen 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.

Inclusion Criteria: * 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 * Expected moderate-to-severe postoperative pain with anticipated need for opioid prescription at discharge * Able and willing to provide written informed consent and comply with all study procedures, including daily electronic data entry via smartphone app Exclusion Criteria: * • 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) * Pregnant or breastfeeding * Participation in another investigational drug or device trial within 30 days prior to enrollment * Planned concomitant major procedure (e.g., other shoulder surgery, fracture fixation, arthroplasty) * Active chemotherapy * Contraindication to any component of the standard multimodal regimen: oxycodone, acetaminophen, aspirin, methocarbamol, or gabapentin * Any condition precluding use of a volatile anesthetic: personal or first-degree family history of malignant hyperthermia or MH-susceptible condition; severe refractory PONV; myopathy or mitochondrial disease; prior severe reaction or allergy to volatile anesthetic * Preoperative chronic pain condition unrelated to the surgical shoulder that could confound postoperative pain assessment (e.g., fibromyalgia, complex regional pain syndrome, active chronic migraine) * Patient declines or regional team is unable to perform the single-shot interscalene block (interscalene regional anesthetic per protocol; non-performance requires withdrawal)

Clinical Research Directory

Suzetrigine for Analgesiain Arthroscopic Rotator Cuff Repair

Summary

Key Details

Conditions

Interventions

Eligibility Criteria