Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN (NCT07548385) | Clinical Trial Compass
RecruitingPhase 3
Suzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN
United States235 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 total knee replacement surgery
* All genders
Exclusion Criteria:
Any individual who meets any of the following criteria will be excluded from participation in this study:
* American Society of Anesthesiology Physical Classification (ASA) Class V
* Urgent or emergent surgery
* Contraindications to administration of Suzetrigine:
* 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)
* Patients with moderate to severe hepatic impairment
* History of substance use disorder or chronic opioid use or alcohol abuse
* Reoperation
* Patient refusal or inability to consent
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing suzetrigine specifically to reduce opioid use after total knee replacement — does my situation make me a good candidate to discuss this option with you, given my pain management history and any medications I'm already taking?
2Since this is a Phase 3 trial, what do you know about the safety data gathered so far for suzetrigine, and how does its risk profile compare to the opioid pain medications I'd likely receive after knee replacement surgery otherwise?
3If I were to participate in this study, how would my post-operative pain actually be managed — would I still have access to opioids as a backup if suzetrigine isn't controlling my pain well enough after surgery?
4Given that the trial is measuring opioid consumption as its main outcome, does that mean the focus is on reducing opioids rather than necessarily proving better pain relief — and how might that affect what my recovery experience could look like?
5Before considering this trial, would you recommend I first explore what standard post-operative pain management after knee replacement would look like for me, so I can compare it against what this study is offering?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.