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Suzetrigine for Opioid-Sparing in Arthroscopic Rotator Cuff Repair
NCT07866638Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2026
- Primary completion
- Sep 2028
- Sponsor
- University of Alabama at Birmingham
- Drugs
- suzetrigine
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial of suzetrigine in postoperative pain (2 arms), sponsored by University of Alabama at Birmingham. Primary endpoints: Inpatient Morphine Milligram Equivalent and Outpatient Opioid Utilization. Planned start Nov 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Treatment arm
Standard multimodal analgesia + suzetrigine
Control arm
Standard multimodal analgesia + matching placebo
03
Who it enrols
Adults 18+ with BMI 18-45 undergoing outpatient primary arthroscopic rotator cuff repair under general anesthesia with interscalene nerve block, expecting moderate-to-severe pain. Excludes those with recent substance/opioid use disorder, chronic opioid use >10 MME/day, hepatic impairment (Child-Pugh B/C), pregnancy, or contraindications to the study drugs or standard multimodal regimen.
04
Endpoints
Primary
Inpatient Morphine Milligram Equivalent
Outpatient Opioid Utilization
Secondary
Pain Interference
Pain During Most Painful Activity (Numeric Rating Scale)
Incidence of Postoperative Nausea and Vomiting
Incidence of Constipation
Time to First Physical Therapy Mobilization
Length of Stay
Healthcare Utilization
Opioid Refills
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