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

NCT07548385 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY-25-01392
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery?
2. 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

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Total amount of opioid consumption required post-operatively.

  5 days

Secondary Outcomes (1)

• Visual analog pain scale

  5 days

Study Arms (2)

Suzetrigine

EXPERIMENTAL

Participants will receive 100 mg loading dose (2 pills) of Suzetrigine medication pre-operatively, then 50 mg dose (1 pill) of Suzetrigine every 12 hours for total of 5 days.

Drug: Suzetrigine

Placebo

PLACEBO COMPARATOR

Participants will receive 2 pills that are made to look like the Suzetrigine pill to take per-operatively, then 1 pill every 12 hours for a total of 5 days.

Drug: Placebo

Interventions

Suzetrigine DRUG

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.

Suzetrigine

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michael Lazar, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Lazar, MD

CONTACT

212-523-2500; michael.lazar@mountsinai.org

Himani Bhatt, DO

CONTACT

212-523-2500; himani.bhatt@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will be responsible for randomizing study participants to either the treatment arm or placebo (non-treatment) arm. Both treatment and placebo medications will be made to look identical so that only the pharmacy will know which arm the participant was assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)