Open Actively Recruiting

Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports

About

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:

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

Primary Purpose
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 4

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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 Stats
Protocol No.
25-2108
Category
Surgery
Contact
  • Dhruv Limaye
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT07355166
For detailed technical eligibility, visit ClinicalTrials.gov.