Suzetrigine in TKA

NCT ID
NCT07864896
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
Hospital for Special Surgery, New York
Conditions
JOURNAVX, Multimodal Analgesia, Nav 1.8, Opioid Cessation, Opioid Consumption, Postoperative, Pain, Pain Management, Randomized Controlled Study, Randomized Controlled Trial, Randomized Controlled Trials, Suzetrigine, Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\), Total Knee Replacement, Total Knee Replacement Arthroplasty, Total Knee Replacement Surgery, Total Knee Replacements

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Suzetrigine in Total Knee Arthroplasty

Enrollment: 148 participants (Estimated).

What is being studied

  • Other: Placebo
  • Drug: Suzetrigine

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Patients undergoing primary TKA with participating surgeons * Age 18 to 80 years old * Planned Discharge to home * Planned use of neuraxial anesthesia * American Society of Anesthesiologist (ASA) Physical Status 1 - 3 * Patients undergoing primary unilateral TKA with participating surgeons Exclusion Criteria: * ASA greater than 3 * Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery) * History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator) * History of QT prolongation * Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device * Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse * Inability to comply with any component of the study protocol * Younger than 18 or greater than 80 years old at the time of enrollment * Patient already on Suzetrigine * Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease/Child Pugh B or C, use of strong CYP3 inhibitors or inducers) * Contraindications to neuraxial anesthesia or any other part of the study protocol * Participation in another investigational drug or device study * Pregnancy * Prior osteotomy of the operative knee * Baseline knee flexion \<60° * History of infection or septic arthritis of the operative knee

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • New York, United States: 1

Sample of listed locations

  • Hospital for Special Surgery — New York, New York, 10021, United States — Recruiting

Study details

Start date
October 7, 2026
Primary completion date
January 1, 2029
Completion date
January 1, 2030
First posted
October 8, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07864896
Registry last updated
October 8, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07864896 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Knee Pain studies | Clinical trial FAQ