Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery

NCT07539623 | Recruiting Phase 3 FDA Drug

• 1 other identifier: STUDY-25-00822
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Total post-operative opioid consumption measured daily in total morphine milligram equivalents.

  5 days

Secondary Outcomes (1)

• Pain Visual Analog scores

  5 days

Study Arms (4)

Bariatric Suzetrigine

EXPERIMENTAL

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.

Drug: Suzetrigine

Bariatric Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Cardiac Suzetrigine

EXPERIMENTAL

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.

Drug: Suzetrigine

Cardiac Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Suzetrigine DRUG

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.

Bariatric Suzetrigine; Cardiac Suzetrigine

Placebo DRUG

Matching placebo

Bariatric Placebo; Cardiac 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 cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
• All genders

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Morningside

New York, New York, 10025, 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

• Himani Bhatt, DO

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Himani Bhatt, DO

CONTACT

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

Michael Lazar, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will randomly assign participants. All pills will be made to look identical prior to supplying to participants, investigators, assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)