Artroscopic SurgeryPhase 4SOARNCT07866638
Suzetrigine for Analgesiain Arthroscopic Rotator Cuff Repair
A Phase 4 study testing Suzetrigine (Journavx) and Standard multimodal analgesia in people with Artroscopic Surgery and Pain Management, run by University of Alabama at Birmingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Artroscopic Surgery, Pain Management, Pain After Shoulder Surgery
- What is being tested?
- Suzetrigine (Journavx) and Standard multimodal analgesia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Show all 12Show fewer
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Roxana Santander Chapeta | Research Coordinator, IMG contact
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating Suzetrigine as an Opioid-Sparing Adjunct to Multimodal Analgesia in Arthroscopic Rotator Cuff Repair
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.
- Conditions
- Artroscopic Surgery, Pain Management, Pain After Shoulder Surgery, Opioid Consumption, Opioid Consumption, Postoperative
- Being tested
- Suzetrigine (Journavx), Matching placebo, Standard multimodal analgesia
- Keywords
- Suzetrigine, Arthroscopic rotator cuff repair, Opioid Consumption
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzetrigine (Journavx)Drug
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.
Matching placeboDrug
Placebo tablets identical in appearance, size, and packaging to suzetrigine tablets. Administered on the same schedule as suzetrigine.
Standard multimodal analgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (n=50): Suzetrigine + Standard Multimodal Analgesia | Experimental | 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. Receives: Drug: Suzetrigine (Journavx); Drug: Standard multimodal analgesia |
| Control arm (n=50): Placebo + Standard Multimodal Analgesia | Placebo comparator | Participants receive standard multimodal analgesia plus matching blinded placebo tablets on the same schedule as the treatment arm. Receives: Drug: Matching placebo; Drug: Standard multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative (PACU arrival through same-day hospital discharge)
Outpatient Opioid Utilization
Total Morphine Milligram Equivalent (MME) based on patient reported oxycodone use via twice-daily questionnaire
Measured: Postoperative Day 0 through Day 13
Secondary outcomes (8)
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.
Measured: Post Operative Day 1, 3, 7, 13
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)
Measured: Postoperative Day 1 through Day 13
Incidence of Postoperative Nausea and Vomiting (PONV)
Antiemetic requirement - chart review + survey
Measured: Post-anesthesia Care Unit (PACU) through Post Operative Day 13
Incidence of Constipation
Patient-reported constipation symptoms via daily questionnaire (yes/no)
Measured: Post Operative Day 1 through Day 13
Time to First Physical Therapy Mobilization
Time to first PT mobilization - chart review
Measured: Day of surgery (same-day discharge)
Length of Stay
Duration of postoperative stay in hours, measured from PACU arrival to hospital discharge, assessed via chart review.
Measured: Day of surgery (same-day discharge)
Healthcare Utilization
Number of emergency department visits and unplanned hospital readmissions, assessed via patient questionnaire
Measured: Hospital discharge through Postoperative Day 21
Opioid Refills
Opioid prescription refills assessed via EHR and PDMP review at 30 days postoperatively
Measured: Hospital discharge through Postoperative Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artroscopic SurgeryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo (Control) vs Study Drug
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Short, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866638
- Sponsor's protocol ID
- IRB-300016923
- Other IDs
- REINVENT Program
- Acronym
- SOAR
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating Suzetrigine as an Opioid-Sparing Adjunct to Multimodal Analgesia in Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07866638
- Acronym / sponsor ID
- SOAR / IRB-300016923
- Conditions
- Artroscopic Surgery, Pain Management, Pain After Shoulder Surgery, Opioid Consumption, Opioid Consumption, Postoperative
- Keywords
- Suzetrigine, Arthroscopic rotator cuff repair, Opioid Consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo (Control) vs Study Drug
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (n=50): Suzetrigine + Standard Multimodal Analgesia | Experimental | Drug: Suzetrigine (Journavx), Drug: Standard multimodal analgesiaParticipants 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. |
| Control arm (n=50): Placebo + Standard Multimodal Analgesia | Placebo comparator | Drug: Matching placebo, Drug: Standard multimodal analgesiaParticipants receive standard multimodal analgesia plus matching blinded placebo tablets on the same schedule as the treatment arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- • 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Treatment arm (n=50): Suzetrigine + Standard Multimodal Analgesia |
| Matching placeboPlacebo tablets identical in appearance, size, and packaging to suzetrigine tablets. Administered on the same schedule as suzetrigine. | Drug | Control arm (n=50): Placebo + Standard Multimodal Analgesia |
| Standard multimodal analgesiaAcetaminophen 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. | Drug | Control arm (n=50): Placebo + Standard Multimodal Analgesia, Treatment arm (n=50): Suzetrigine + Standard Multimodal Analgesia |
Primary outcome
Inpatient Morphine Milligram Equivalent (MME)
Time frame: 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
Time frame: Postoperative Day 0 through Day 13
Total Morphine Milligram Equivalent (MME) based on patient reported oxycodone use via twice-daily questionnaire
8 secondary outcomes
Pain Interference
Time frame: Post Operative Day 1, 3, 7, 13
Pain During Most Painful Activity (Numeric Rating Scale)
Time frame: Postoperative Day 1 through Day 13
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: Post-anesthesia Care Unit (PACU) through Post Operative Day 13
Incidence of Constipation
Time frame: Post Operative Day 1 through Day 13
Time to First Physical Therapy Mobilization
Time frame: Day of surgery (same-day discharge)
Length of Stay
Time frame: Day of surgery (same-day discharge)
Healthcare Utilization
Time frame: Hospital discharge through Postoperative Day 21
Opioid Refills
Time frame: Hospital discharge through Postoperative Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Artroscopic Surgery
Not yet recruiting
Comparison of the Effectiveness of USG-Guided Interscalene Block Versus Combined Interscalen-Suprascapular Block for Arthroscopic Shoulder Surgery
Shoulder Pain, Artroscopic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roxana Santander Chapeta | Research Coordinator, IMG contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suzetrigine (Journavx) and Standard multimodal analgesia in people with Artroscopic Surgery and Pain Management, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland T Short | Associate Professor, MD ((205) 934-6501, rtshort@uabmc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inpatient Morphine Milligram Equivalent (MME) (time frame: Perioperative (PACU arrival through same-day hospital discharge)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.