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RecruitingAccepts healthy volunteersPhase 3

Suzetrigine in TKA

Hospital for Special Surgery, New York · NCT07864896

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–80 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
148
US sites recruiting
1
Study start
October 15, 2026
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Placebo; Suzetrigine

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 criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Hospital for Special Surgery

    New York, NY 10021

    Site contact: Alexandra Sideris, PhD · 212-774-2602 · siderisa@hss.edu

Study contacts (from the official record)

  • Curtis Weh, B.S. · 917-260-3937 · wehc@hss.edu
  • Hannah Gerner, MD · 646-714-6509 · Gernerha@hss.edu
All healthy volunteers studies in New York →
Suzetrigine in TKA (NCT07864896) | Bored Studies