Recruiting
Phase 3

Suzetrigine

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT07864896

Conditions

Total Knee Arthroplasty (TKA)

Total Knee Arthroplasty \(TKA\)

Total Knee Replacement

Total Knee Replacement Surgery

Total Knee Replacements

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Placebo

Suzetrigine

Study Details

Brief summary:

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).

Conditions

Total Knee Arthroplasty (TKA)

Total Knee Arthroplasty \(TKA\)

Total Knee Replacement

Total Knee Replacement Surgery

Total Knee Replacements

Study ID

NCT07864896

Start date

Oct 7, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo arm

experimental: Suzetrigine

Interventions

Placebo

This will be a placebo 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.

Primary outcome measure

  • Cumulative opioid consumption within the first 48 hours after TKA starting from post-anesthesia care unit entry (t=0), in oral morphine equivalents (OME) [ Time Frame: From entry into the post-anesthesia care unit (PACU) to 48 hours after THA surgery ]

Central Contacts and Locations

Central contacts

Curtis Weh, B.S.

917-260-3937wehc@hss.edu

Hannah Gerner, MD

646-714-6509Gernerha@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Alexandra Sideris, PhD

212-774-2602siderisa@hss.edu

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Oct 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.