Suzetrigine added to multimodal opioid-sparing pain care for heart and weight-loss surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, phase 3 study comparing suzetrigine versus placebo added to an established multimodal analgesic regimen for adults undergoing bariatric surgery or cardiac surgery via sternotomy. Participants aged 18–85 who are scheduled for elective procedures and who are not chronic opioid users or have substance use disorder will be enrolled and randomized. The main outcomes are post-operative opioid consumption and pain scores, with exclusions for urgent/emergent cases, ASA class V, reoperation, and concomitant use of strong/moderate CYP3A inhibitors or inducers. The trial is conducted at Mount Sinai Morningside and follows participants through the immediate post-operative period for analgesic outcomes.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mount Sinai Morningside
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Himani Bhatt, DO — Icahn School of Medicine at Mount Sinai
• Study coordinator: Himani Bhatt, DO
• Email: himani.bhatt@mountsinai.org
• Phone: 212-523-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.