Suzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIcahn School of Medicine at Mount Sinai
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 18-85 years old
Scheduled to undergo cardiac procedures via sternotomy or bariatric surgery (laparoscopic or open)
All genders
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Suzetrigine
DrugSuzetrigine 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
DrugMatching placebo
Treatment groups
235 Participants
are divided into 4 treatment groupsGroup A: Bariatric SuzetrigineExperimental treatment 1 intervention
Group B: Bariatric PlaceboPlacebo comparator 1 intervention
Group C: Cardiac SuzetrigineExperimental treatment 1 intervention
Group D: Cardiac PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid Consumption
Total post-operative opioid consumption measured daily in total morphine milligram equivalents.
Time frame
5 daysSecondary outcomes
1
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 daysSponsors and contacts
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Source ClinicalTrials.gov