Bariatric Surgery, Cardiac Surgery With Sternotomy, Post-operative Pain
Conditions
Brief summary
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.
Interventions
DRUGSuzetrigine
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.
DRUGPlacebo
Matching placebo
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 5 days | Total post-operative opioid consumption measured daily in total morphine milligram equivalents. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Visual Analog scores | 5 days | Post-operative pain scores will be measured daily using visual analog scale for pain. Total score from 0-10, higher score indicates more pain. |
Countries
United States
Contacts
CONTACTHimani Bhatt, DO
CONTACTMichael Lazar, MD
PRINCIPAL_INVESTIGATORHimani Bhatt, DO
Icahn School of Medicine at Mount Sinai
Outcome results
None listed