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Not yet recruitingNCT07866638SOARUpdated Oct 8, 2026

Suzetrigine for Analgesiain Arthroscopic Rotator Cuff Repair

A Phase 4 interventional study of Suzetrigine (Journavx) and Matching placebo in Artroscopic Surgery, Pain Management and Pain After Shoulder Surgery, sponsored by University of Alabama at Birmingham. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Suzetrigine
  • Arthroscopic rotator cuff repair
  • Opioid Consumption
03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

Browse Agnosia studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,397 studies on the registry; 285 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Treatment arm (n=50): Suzetrigine + Standard Multimodal Analgesia

    Participants receive standard multimodal analgesia plus blinded study drug (suzetrigine). Loading dose administered preoperatively, followed by twice-daily maintenance dosing for 13.5 days post-discharge.

    Drug: Suzetrigine (Journavx) · Drug: Standard multimodal analgesia

  • Placebo comparator
    Control arm (n=50): Placebo + Standard Multimodal Analgesia

    Participants receive standard multimodal analgesia plus matching blinded placebo tablets on the same schedule as the treatment arm.

    Drug: Matching placebo · Drug: Standard multimodal analgesia

Interventions

  • DrugSuzetrigine (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.

  • DrugMatching placebo

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

  • DrugStandard 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Perioperative (PACU arrival through same-day hospital discharge)

  2. Outpatient Opioid Utilization

    Total Morphine Milligram Equivalent (MME) based on patient reported oxycodone use via twice-daily questionnaire

    Time frame: Postoperative Day 0 through Day 13

Secondary outcomes

  1. 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.

    Time frame: Post Operative Day 1, 3, 7, 13

  2. 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)

    Time frame: Postoperative Day 1 through Day 13

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Antiemetic requirement - chart review + survey

    Time frame: Post-anesthesia Care Unit (PACU) through Post Operative Day 13

  4. Incidence of Constipation

    Patient-reported constipation symptoms via daily questionnaire (yes/no)

    Time frame: Post Operative Day 1 through Day 13

  5. Time to First Physical Therapy Mobilization

    Time to first PT mobilization - chart review

    Time frame: Day of surgery (same-day discharge)

  6. Length of Stay

    Duration of postoperative stay in hours, measured from PACU arrival to hospital discharge, assessed via chart review.

    Time frame: Day of surgery (same-day discharge)

  7. Healthcare Utilization

    Number of emergency department visits and unplanned hospital readmissions, assessed via patient questionnaire

    Time frame: Hospital discharge through Postoperative Day 21

  8. Opioid Refills

    Opioid prescription refills assessed via EHR and PDMP review at 30 days postoperatively

    Time frame: Hospital discharge through Postoperative Day 30

Other outcomes

  1. Feasibility - Enrollment

    Percentage of eligible patients enrolled in the study

    Time frame: Through study completion, approximately 24 months

  2. Feasibility - Study Drug Adherence

    Percentage of days with at least one study drug dose taken (suzetrigine or placebo), assessed in both arms

    Time frame: Postoperative Day 1 through Day 13

  3. Feasibility - Questionnaire Data Capture

    Percentage of scheduled questionnaire entries completed by participants in both arms

    Time frame: Postoperative Day 1 through Day 13

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866638
Lead sponsor
University of Alabama at Birmingham
Responsible party
Roland Short (Roland Short, MD | Associate Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Roland T Short | Associate Professor, MD
Contact
rtshort@uabmc.com
(205) 934-6501
Roxana Santander Chapeta | Research Coordinator, IMG
Contact
rsantanderchapeta@uabmc.edu
(205) 975.2846

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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