Recruiting
Phase 3

Suzetrigine

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07548385

Conditions

Total Knee Replacement Surgery

Post-operative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Placebo

Study Details

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. 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

Study ID

NCT07548385

Start date

Apr, 2026

Status verified date

Apr, 2026

Completion date

Feb 23, 2027

Anticipated

Primary completion date

Feb 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

235 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Matching placebo

Primary outcome measure

  • Opioid Consumption [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Michael Lazar, MD

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

Himani Bhatt, DO

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

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Michael Lazar, MD

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

Himani Bhatt, DO

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

Principal Investigator:

Michael Lazar

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-04-23.