Recruiting
Phase 3

Suzetrigine

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07539623

Conditions

Bariatric Surgery

Cardiac Surgery With Sternotomy

Post-operative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Suzetrigine

Placebo

Study Details

Brief summary:

This is prospective, randomized study. The purpose of this study is to evaluate whether the addition of Suzetrigine to well established multimodal pain regimen for participants undergoing bariatric patients undergoing weight-loss surgery and cardiac patients undergoing sternotomy will reduce post-operative opioid consumption and pain scores.

Conditions

Bariatric Surgery

Cardiac Surgery With Sternotomy

Post-operative Pain

Study ID

NCT07539623

Start date

May 1, 2026

Status verified date

May, 2026

Completion date

Dec 22, 2026

Anticipated

Primary completion date

Dec 22, 2026

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 cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
  • All genders

Exclusion Criteria:

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

  • ASA Class V
  • Urgent or emergent surgery
  • Contraindications to administration of Suzetrigine (e.g. concomitant use of strong CYP3A inhibitors)
  • History of substance use disorder or chronic opioid use
  • Reoperation
  • Patient refusal or inability to consent
  • 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)

Study Design

Enrollment

235 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bariatric Suzetrigine

Participants undergoing bariatric surgery will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.

placebo comparator: Bariatric Placebo

Participants undergoing bariatric surgery will receive 2 pills of a placebo pill made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.

experimental: Cardiac Suzetrigine

Participants undergoing cardiac surgery with sternotomy will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.

placebo comparator: Cardiac Placebo

Participants undergoing cardiac surgery with sternotomy will receive 2 pills made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.

Interventions

Suzetrigine

Suzetrigine is a new pain medication that works by blocking a specific sodium channel (NAV 1.8) in the peripheral nerves and preventing pain signals from reaching the spinal cord and brain.

Placebo

Matching placebo

Primary outcome measure

  • Opioid Consumption [ Time Frame: 5 days ]

Central Contacts and Locations

Central contacts

Himani Bhatt, DO

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

Michael Lazar, MD

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

Locations

Mount Sinai Morningside

Recruiting

New York, New York, United States, 10025

Contacts

Himani Bhatt, DO

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

Michael Lazar, MD

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

Principal Investigator:

Himani Bhatt

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

May 14, 2026

Last verified

May, 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 2026-05-14.