Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control.
1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.
Eligibility criteria
Qualifiers
Adults 18-85 years old
Scheduled to undergo total knee replacement surgery
All genders
Disqualifiers
American Society of Anesthesiology Physical Classification (ASA) Class V
Urgent or emergent surgery
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)
Trial design
Treatments tested in this trial
- Suzetrigine
- Placebo
Treatment groups
235 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov