Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports

NCT07355166 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-25-2108
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a Suzetrigine-based multimodal pain regimen can reduce the volume of opioid consumption while maintaining non-inferior pain control compared to an opioid-based multimodal pain regimen after common ambulatory orthopaedic sports procedures. The main questions it aims to answer are:

1. 1.Does including Suzetrigine in the multimodal pain regimen lower the volume of opioids consumed by participants while maintaining non-inferior pain control?
2. 2.How does the side-effect profile of a Suzetrigine-based multimodal postop pain regimen compare to that of an opioid-based multimodal postoperative pain regimen?

Conditions

Postoperative Pain Management

Keywords

Suzetrigine; Journavx; Opioid Use; ACL Reconstruction; Rotator Cuff Repair; Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• 7-Day MME Consumption

  Total opioids consumed by patients measured in morphine milliequivalents for the first seven days postoperatively

  7 days

Secondary Outcomes (4)

• SPID-48

  48 hours

• 7-Day Opioid Free Rate

  7 days

• Opioid Side Effect Rate

  7 days

• Suzetrigine Side Effect Rate

  7 Days

Study Arms (2)

Suzetrigine Arm

EXPERIMENTAL

Patients in both groups will receive a common multimodal pain control regimen which includes a preoperative regional anesthesia, a 14-day supply of 1000mg acetaminophen BID, and a 14-day supply of 500mg naproxen BID. Patients randomized to the Suzetrigine arm will receive a loading dose of Suzetrigine 100mg in PACU postoperatively and a 7-day supply of 50mg suzetrigine BID for 1 week total. Patients in this group will also receive 25 tablets of 5mg of oxycodone for rescue pain control.

Drug: Suzetrigine

Opioid Arm

EXPERIMENTAL

Patients in both groups will receive a common multimodal pain control regimen which includes a preoperative regional anesthesia, a 14-day supply of 1000mg acetaminophen BID, and a 14-day supply of 500mg naproxen BID. Patients randomized to the Opioid arm will also receive 25 tablets of 5mg of oxycodone and will not receive a Suzetrigine prescription.

Drug: Multimodal Pain Regimen

Interventions

Suzetrigine DRUG

Patients in this group will receive a preoperative regional anesthesia block, a 14-day supply of 1000mg acetaminophen BID, a 14-day supply of 500mg naproxen BID, a loading dose of Suzetrigine 100mg in PACU postoperatively, a 7-day supply of 50mg suzetrigine BID and 25 tablets of 5mg of oxycodone for rescue pain control postoperatively.

Also known as: Journavx

Suzetrigine Arm

Multimodal Pain Regimen DRUG

Patients in this group will receive a preoperative regional anesthesia block, a 14-day supply of 1000mg acetaminophen BID, a 14-day supply of 500mg naproxen BID, and 25 tablets of 5mg of oxycodone for PRN pain control postoperatively.

Opioid Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing reconstruction of primary ACL tear

You may not qualify if:

• Concurrent ligamentous injuries requiring surgical intervention
• Full thickness cartilage injury requiring discrete surgical intervention
• Chronic opioid use
• Significant hepatic disease (Child/Pugh C)
• Women who are pregnant or breastfeeding
• Women of childbearing age using hormonal contraceptives containing progestins other than levonorgestrel and norethindrone
• Allergies or intolerance to any study medications
• Inability to complete ePROs (due to literacy or infirmity)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Related Publications (1)

• Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of NaV1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870.

  PMID: 37530822 BACKGROUND

Central Study Contacts

Jomar Aryee, MD

CONTACT

3108256557; jaryee@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical Analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Sports Fellow

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share