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NCT Number: NCT07539623

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

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.

Recruiting

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Key information

Conditions

Bariatric Surgery Cardiac Surgery With Sternotomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Drug

Matching placebo

Primary outcomes

  1. Opioid Consumption

    Time frame: 5 days

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

Secondary outcomes

  1. Pain Visual Analog scores

    Time frame: 5 days

    Post-operative pain scores will be measured daily using visual analog scale for pain. Total score from 0-10, higher score indicates more pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Himani Bhatt, DO

CONTACT

[email protected]

212-523-2500

Michael Lazar, MD

CONTACT

[email protected]

212-523-2500

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Acronym: SMOOTH-SURG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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