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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Pharmacy will randomly assign participants. All pills will be made to look identical prior to supplying to participants, investigators, assessors.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bariatric Suzetrigine 		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.
  • 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.
Placebo Comparator
Bariatric Placebo 		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.
  • Drug: Placebo
    Matching placebo
Experimental
Cardiac Suzetrigine 		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.
  • 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.
Placebo Comparator
Cardiac Placebo 		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.
  • Drug: Placebo
    Matching placebo

Recruiting Locations

Mount Sinai Morningside
New York, New York 10025
Contact:
Himani Bhatt, DO
212-523-2500
himani.bhatt@mountsinai.org

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Himani Bhatt, DO
212-523-2500
himani.bhatt@mountsinai.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.