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

ConditionsBariatric Surgery Cardiac Surgery With Sternotomy Post-operative Pain

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-85

SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

Qualifiers

Adults 18-85 years old

Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)

All genders

Disqualifiers

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

Trial design

Treatments tested in this trial

Suzetrigine
Placebo

Treatment groups

235 Participants

are divided into 4 treatment groups

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov