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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Suzetrigine | Experimental | 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. |
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| Bariatric Placebo | Placebo Comparator | 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. |
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| Cardiac Suzetrigine | Experimental | 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. |
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| Cardiac Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suzetrigine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Total post-operative opioid consumption measured daily in total morphine milligram equivalents. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Visual Analog scores | Post-operative pain scores will be measured daily using visual analog scale for pain. Total score from 0-10, higher score indicates more pain. | 5 days |
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Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
Any individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Himani Bhatt, DO | Contact | 212-523-2500 | himani.bhatt@mountsinai.org | |
| Michael Lazar, MD | Contact | 212-523-2500 | michael.lazar@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Himani Bhatt, DO | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Morningside | Recruiting | New York | New York | 10025 | United States |
Reasons not to share individual participant data focus on protecting participant privacy, maintaining study integrity, and respecting intellectual property.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Pharmacy will randomly assign participants. All pills will be made to look identical prior to supplying to participants, investigators, assessors.
| Placebo | Drug | Matching placebo |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |