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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07539623
Phase
PHASE3
Status
Recruiting
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Conditions

  • Bariatric Surgery
  • Cardiac Surgery With Sternotomy
  • Post-operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • Placebo — DRUG
    Matching placebo

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Dec 22, 2026
Completion
Dec 22, 2026

Study Design

Enrollment
235 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Opioid Consumption [ Time Frame: 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai MorningsideNew YorkNew York10025
Himani Bhatt, DO
[email protected]
212-523-2500
Michael Lazar, MD
[email protected]
212-523-2500
Himani Bhatt (PRINCIPAL_INVESTIGATOR)

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Mount Sinai Morningside· New York, NY

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