Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports

Suzetrigine Versus Usual-care Opioids for Postoperative Pain After Common Ambulatory Orthopaedic Sports Procedures - A Randomized Control Trial

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. Does including Suzetrigine in the multimodal pain regimen lower the volume of opioids consumed by participants while maintaining non-inferior pain control?
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?

Eligible participants will be assigned to receive one of the postop pain regimens and report their opioid use, their pain level, and the side effects they faced every day for 7 days.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Drug: Suzetrigine; Drug: Multimodal Pain Regimen

Detailed Description

Pain control after most arthroscopic and open orthopaedic sports surgeries in the ambulatory setting is dependent on multimodal pain regimens that include the use of narcotics. These medications are often considered necessary for appropriate pain control but pose risks of harm to patients through systemic side effects, potential for overdose, and potential for long-term dependence. They also pose risks to society through diversion, fueling the economically burdensome opioid crisis, and being a nidus for drug-related crimes. Suzetrigine (Journavx) was FDA-approved in January of 2025 for use in the management of acute pain. It is the first non-opioid analgesic approved since celecoxib (anti-inflammatory) in the late 1990's and has been shown to provide non-inferior pain control when compared to placebo as well as to opioid-based drug regimens in some postoperative settings. It's efficacy in reducing postoperative opioid exposure without sacrificing pain control after common ambulatory orthopaedic sports procedures that already use multimodal/regional anesthesia has yet to be studied in a controlled fashion.

At the University of Califronia Los Angeles (UCLA), multimodal strategies for patients undergoing common ambulatory orthopaedic sports procedures like primary ACL reconstruction or rotator cuff repair currently include regional anesthesia, acetaminophen, NSAIDs, and opioids. Since FDA approval, Suzetrigine has been incorporated into postoperative pain management at UCLA for select patients, but has not been uniformly adopted. Evaluating its role in a controlled, randomized setting among patients undergoing common ambulatory Orthopaedic sports procedures will provide important data on best practices when incorporating it within current multimodal protocols as well as its impact on postoperative opioid use in these settings.

This study aims to evaluate its efficacy and opioid-sparing potential in patients undergoing an archetypal outpatient, Orthopaedic sports knee procedure - primary ACL reconstruction - and to inform its potential integration into enhanced recovery pathways.

This aim will be achieved by investigating whether a Suzetrigine based multimodal regimen affects total opioid consumption over 7 days after surgery when compared to an opioid-based multimodal regimen, while maintaining non-inferior pain control at 48 hours

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jomar Aryee, MD; Phone Number: 3108256557; Email: jaryee@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing reconstruction of primary ACL tear

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suzetrigine Arm; 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; 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.; Other Names: Journavx
Experimental: Opioid Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-Day MME Consumption	Total opioids consumed by patients measured in morphine milliequivalents for the first seven days postoperatively	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SPID-48	Time-weighted Sum of Pain Intensity Difference over 48 hours used to quantify pain relief by summing a patient's pain reduction from their baseline score over a 48-hour period.	48 hours
7-Day Opioid Free Rate	The percentage of patients who avoid opioid use after medical procedures	7 days
Opioid Side Effect Rate	Proportion of patients reporting instances of nausea, constipation, dizziness, or loss of appetite	7 days
Suzetrigine Side Effect Rate	Proportion of patients reporting muscle aches, muscle spasm, or itchiness	7 Days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ACL Reconstruction; Opioid Use; Rotator Cuff Repair; Postoperative Pain Management; Suzetrigine; Journavx
• Other Study ID Numbers: IRB-25-2108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No