Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery (SMOOTH-SURG)

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.

Study Overview

• Status: Recruiting
• Conditions: Post-operative Pain; Bariatric Surgery; Cardiac Surgery With Sternotomy
• 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, 10025
      • Recruiting
      • Mount Sinai Morningside
      • 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: Himani Bhatt

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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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 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.	Drug: Placebo; Matching placebo
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.	Drug: 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 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.	Drug: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Total post-operative opioid consumption measured daily in total morphine milligram equivalents.	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analog scores	Post-operative pain scores will be measured daily using visual analog scale for pain. Total score from 0-10, higher score indicates more pain.	5 days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Himani Bhatt, DO, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 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-25-00822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Reasons not to share individual participant data focus on protecting 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