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

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

This trial will test whether adding suzetrigine to standard multimodal pain care lowers opioid use and pain after bariatric or open-heart (sternotomy) surgery in adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07539623 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–85 scheduled for elective bariatric surgery (laparoscopic or open) or cardiac surgery via sternotomy who are opioid-naïve, able to consent, and not taking contraindicated CYP3A inhibitors or inducers are ideal candidates.

Not a fit: Patients having urgent or emergent surgery, ASA class V, chronic opioid users or those with substance use disorder, reoperations, or those taking contraindicated CYP3A modulators are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding suzetrigine could reduce the need for opioids after surgery and lower post-operative pain and opioid-related side effects.

How similar studies have performed: Multimodal opioid-sparing approaches have previously reduced opioid needs after surgery, but adding suzetrigine is a novel approach with limited published clinical data to date.

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)

Where this trial is running

New York, New York

• 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

Conditions Bariatric Surgery; Cardiac Surgery With Sternotomy; Post-operative Pain