Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07355166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports
Sponsor:
University of California, Los Angeles
Organization:
Study Overview
Official Title:
Suzetrigine Versus Usual-care Opioids for Postoperative Pain After Common Ambulatory Orthopaedic Sports Procedures - A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: