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

NCT07548385 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2026-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Total Knee Replacement Surgery
  • Post-operative Pain

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

Sponsors & Collaborators

Principal Investigators

  • Michael Lazar, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-02-23
Completion
2027-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07548385 on ClinicalTrials.gov