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临床试验/NCT07355166
NCT07355166尚未招募4 期

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

University of California, Los Angeles0 个研究点目标入组 140 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
140
主要终点
7-Day MME Consumption

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Statistical Analyst

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing reconstruction of primary ACL tear

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: Suzetrigine (Drug)

结局指标

主要结局

7-Day MME Consumption

时间窗: 7 days

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

次要结局

  • SPID-48(48 hours)
  • 7-Day Opioid Free Rate(7 days)
  • Opioid Side Effect Rate(7 days)
  • Suzetrigine Side Effect Rate(7 Days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jomar Aryee

Orthopaedic Sports Fellow

University of California, Los Angeles

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