Suzetrigine in TKA
Public ClinicalTrials.gov record NCT07864896. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Trial of Suzetrigine in Total Knee Arthroplasty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Total knee 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 total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 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).
Study identification
- NCT ID
- NCT07864896
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 148 participants
Conditions and interventions
Conditions
- Total Knee Arthroplasty (TKA)
- Total Knee Arthroplasty \(TKA\)
- Total Knee Replacement
- Total Knee Replacement Surgery
- Total Knee Replacements
- Total Knee 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
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2026 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- Jan 2030 (Estimated)
- Last update posted
- Oct 8, 2026
2026 – 2030
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07864896, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2026 · Synced Oct 10, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07864896 live on ClinicalTrials.gov.