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Recruiting NCT07539623

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

Phase III Interventional Bariatric Surgery Cardiac Surgery With Sternotomy Post-operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Suzetrigine, Placebo.
Who it may be relevant to
Registry conditions: Bariatric Surgery, Cardiac Surgery With Sternotomy, Post-operative Pain. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 Placebo
    Matching placebo

Primary outcome measures

  • Opioid Consumption [Time frame: 5 days]
Secondary outcome measures (1)
  • Pain Visual Analog scores [Time frame: 5 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mount Sinai Morningside — New York

Identifiers

NCT: NCT07539623 · STUDY-25-00822

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗