Suzetrigine in TKA

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT07864896
Phase
PHASE3
Status
Recruiting
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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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — OTHER
    This will be a placebo drug.
  • Suzetrigine — DRUG
    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.

Study Details

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).

Key Dates

First listed
Oct 8, 2026
Start date
Oct 15, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo arm
  • Experimental: Suzetrigine

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

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Alexandra Sideris, PhD
[email protected]
212-774-2602

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By research site
Hospital for Special Surgery· New York, NY

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