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Recruiting NCT07548385

Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN

Phase III Interventional Total Knee Replacement Surgery Post-operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suzetrigine, Placebo.
Who it may be relevant to
Registry conditions: Total Knee Replacement Surgery, Post-operative Pain. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.

Interventions

  • Drug Suzetrigine
    Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.
  • Drug Placebo
    Matching placebo

Primary outcome measures

  • Opioid Consumption [Time frame: 5 days]
Secondary outcome measures (1)
  • Visual analog pain scale [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Adults 18-85 years old
  • Scheduled to undergo total knee replacement surgery
  • All genders

Exclusion criteria

Any individual who meets any of the following criteria will be excluded from participation in this study:

  • American Society of Anesthesiology Physical Classification (ASA) Class V
  • Urgent or emergent surgery
  • Contraindications to administration of Suzetrigine:
  • Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin)
  • Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin)
  • Patients with moderate to severe hepatic impairment
  • History of substance use disorder or chronic opioid use or alcohol abuse
  • Reoperation
  • Patient refusal or inability to consent
  • Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai West — New York

Identifiers

NCT: NCT07548385 · STUDY-25-01392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗