Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
NCT07539623 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 235
Last updated 2026-05-14
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
Interventions
- 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.
- DRUG
-
Matching placebo
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Himani Bhatt, DO · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2026-12-22
- Completion
- 2026-12-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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