Suzetrigine for Postoperative Pain

(SMOOTH-SURG Trial)

Overseen By Michael Lazar, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Substance use disorder, Chronic opioid use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

235 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Himani Bhatt, DO

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 85 years old.

I am scheduled for heart surgery through the chest or weight loss surgery.

My gender does not affect my eligibility.

Exclusion Criteria

ASA Class V

I am unable or unwilling to give my consent to participate.

History of substance use disorder or chronic opioid use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Suzetrigine or placebo pre-operatively and every 12 hours post-operatively for 5 days

5 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

How Is the Trial Designed?

Group I: Cardiac Suzetrigine Experimental Treatment 1 Intervention

Participants undergoing cardiac surgery with sternotomy will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.

Group II: Bariatric Suzetrigine Experimental Treatment 1 Intervention

Participants undergoing bariatric surgery will receive 100 mg loading dose (2 pills) of Suzetrigine pre-operatively and 50 mg dose (1 pill) every 12 hours after for a total of 5 days.

Group III: Bariatric Placebo Placebo Group 1 Intervention

Participants undergoing bariatric surgery will receive 2 pills of a placebo pill made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.

Group IV: Cardiac Placebo Placebo Group 1 Intervention

Participants undergoing cardiac surgery with sternotomy will receive 2 pills made to look like Suzetrigine capsule pre-operatively and 1 pill every 12 hours after for a total of 5 days.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+