A Phase 3 interventional study of Suzetrigine and Placebo in Bariatric Surgery, Cardiac Surgery With Sternotomy and Post-operative Pain, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 3, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 235 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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
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
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
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
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.
Matching placebo
Opioid Consumption
Total post-operative opioid consumption measured daily in total morphine milligram equivalents.
Time frame: 5 days
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.
Time frame: 5 days
Plan to share: No — Reasons not to share individual participant data focus on protecting participant privacy, maintaining study integrity, and respecting intellectual property.
No publications or documents are linked to this record.
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Icahn School of Medicine at Mount Sinai