Suzetrigine in Total Hip Arthroplasty
NCT07226700 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2026-01-29
Summary
Total hip and knee joint replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating Suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of Suzetrigine's efficacy in joint replacement is of high clinical value. In this study, patients undergoing primary total hip replacement will be randomized to receive either Suzetrigine or placebo for seven days, with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).
Conditions
- Total Hip Arthroplasty (THA)
- Total Hip Arthroplasty \(THA\)
- Total Hip Replacement
- Total Hip Replacement Surgery
- Total Hip Replacements
- Total Hip Replacement Arthroplasty
- Suzetrigine
- Pain Management
- Pain
- Nav 1.8
- JOURNAVX
- Opioid Cessation
- Opioid Consumption, Postoperative
- Multimodal Analgesia
- Randomized Controlled Trial
- Randomized Controlled Study
- Randomized Controlled Trials
Interventions
- DRUG
-
Suzetrigine
Suzetrigine is a new novel peripherally acting non-opioid pain medication recently approved by the FDA that exerts its analgesic effects by binding to the peripherally located Nav1.8 Sodium channel receptors present on peripheral nerves.
- OTHER
-
Placebo
This will be a placebo drug.
Sponsors & Collaborators
-
Hospital for Special Surgery, New York
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-11-03
- Primary Completion
- 2027-11-01
- Completion
- 2028-11-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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