Artroscopic Surgery, Pain Management, Pain After Shoulder Surgery, Opioid Consumption, Opioid Consumption, Postoperative
Conditions
Keywords
Suzetrigine, Arthroscopic rotator cuff repair, Opioid Consumption
Brief 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.
Detailed description
This is a prospective, single-site, randomized, double-blind, placebo-controlled, two-arm pilot trial. One hundred adult patients undergoing outpatient arthroscopic rotator cuff repair will be enrolled and randomized 1:1 to one of two arms: * Treatment arm (n=50): Standard multimodal analgesia + suzetrigine * Control arm (n=50): Standard multimodal analgesia + matching placebo Both arms follow an identical perioperative protocol and receive identical-appearing study drug kits. Participants, investigators, and all clinical staff will be blinded to treatment assignment throughout the study period. The research pharmacist will prepare and dispense kits labeled by randomization number only; neither the participant nor the clinical team will know the allocated arm. Emergency unblinding will be available 24 hours per day via the research pharmacist. Formal unblinding will occur only after database lock.
Interventions
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.
DRUGMatching placebo
Placebo tablets identical in appearance, size, and packaging to suzetrigine tablets. Administered on the same schedule as suzetrigine.
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Placebo (Control) vs Study Drug
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Morphine Milligram Equivalent (MME) | Perioperative (PACU arrival through same-day hospital discharge) | Cumulative opioid utilization in morphine milligram equivalent (MME) from PACU arrival through hospital discharge, obtained via medication administration record review |
| Outpatient Opioid Utilization | Postoperative Day 0 through Day 13 | Total Morphine Milligram Equivalent (MME) based on patient reported oxycodone use via twice-daily questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Interference | Post Operative Day 1, 3, 7, 13 | 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) | Postoperative Day 1 through Day 13 | 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) | Post-anesthesia Care Unit (PACU) through Post Operative Day 13 | Antiemetic requirement - chart review + survey |
| Incidence of Constipation | Post Operative Day 1 through Day 13 | Patient-reported constipation symptoms via daily questionnaire (yes/no) |
| Time to First Physical Therapy Mobilization | Day of surgery (same-day discharge) | Time to first PT mobilization - chart review |
| Length of Stay | Day of surgery (same-day discharge) | Duration of postoperative stay in hours, measured from PACU arrival to hospital discharge, assessed via chart review. |
| Healthcare Utilization | Hospital discharge through Postoperative Day 21 | Number of emergency department visits and unplanned hospital readmissions, assessed via patient questionnaire |
| Opioid Refills | Hospital discharge through Postoperative Day 30 | Opioid prescription refills assessed via EHR and PDMP review at 30 days postoperatively |
Contacts
CONTACTRoland T Short | Associate Professor, MD
CONTACTRoxana Santander Chapeta | Research Coordinator, IMG
Outcome results
None listed