Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
Recruiting
Phase 3
Interventional Study
Bariatric Surgery
Cardiac Surgery With Sternotomy
Post-operative Pain
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 235 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Other
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About 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.
Trial Locations
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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 w…
Contacts