Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN (STRIDE-PAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain; Total Knee Replacement Surgery
• Intervention / Treatment: Drug: Placebo; Drug: Suzetrigine

• Study Type: Interventional
• Enrollment (Estimated): 235
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Himani Bhatt, DO; Phone Number: 212-523-2500; Email: himani.bhatt@mountsinai.org
• Study Contact Backup: Name: Michael Lazar, MD; Phone Number: 212-523-2500; Email: michael.lazar@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Recruiting
      • Mount Sinai West
      • Contact: Himani Bhatt, DO; Phone Number: 212-523-2500; Email: himani.bhatt@mountsinai.org
      • Contact: Michael Lazar, MD; Phone Number: 212-523-2500; Email: michael.lazar@mountsinai.org
      • Principal Investigator: Michael Lazar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suzetrigine; 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; 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.
Placebo Comparator: Placebo; 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; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total amount of opioid consumption required post-operatively.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog pain scale	Participants perceived post-operative pain measured daily using the visual analog scale for pain. Total score is 0 to 10, higher score indicates more pain.	5 days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Michael Lazar, MD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): February 23, 2027
• Study Completion (Estimated): February 23, 2027

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: STUDY-25-01392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not sharing IPD to protect participant privacy, maintaining study integrity, and respecting intellectual property

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No