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NCT07355166
Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports
Conditions: Postoperative Pain Management
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 140
Sponsor: University of California, Los Angeles
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07355166). StuddyBuddy aggregates publicly available trial information.