Suzetrigine for Pain Management in Total Knee Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This proposal seeks to determine if the addition of Suzetrigine, a novel non-opioid pain medication, to a standardized multimodal pain management pathway significantly reduces total postoperative opioid consumption (measured in Morphine Milligram Equivalents \[MME\]) and improves patient-reported pain scores during the first 14 days following primary total knee arthroplasty (TKA). Prior to conducting a definitive randomized control trial (RCT), we propose a pilot study to inform the trial's design and feasibility.
Objective: To inform the design and feasibility of a definitive RCT comparing postoperative pain control with and without Suzetrigine after TKA. To achieve this objective, we will conduct a pilot trial and address the following aims:
1\) to determine if participant enrollment is feasible, 2) to assess compliance with treatment protocol and key aspects of the protocol, and 3) to refine data collection methods.
Who Is on the Research Team?
Peter Hsiue, MD
Principal Investigator
University of California, Irvine
Steven Yang, MD
Principal Investigator
University of California, Irvine
Are You a Good Fit for This Trial?
This trial is for adults who are having their first total knee replacement surgery. People with certain medical conditions or allergies, or those unable to follow the study plan, may not be able to participate.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
Trial Overview
The study tests whether adding Suzetrigine, a new non-opioid pain medicine, to standard pain management after knee replacement surgery can reduce opioid use and improve pain control in the first two weeks after surgery. Participants are randomly assigned to receive either Suzetrigine or usual care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The Suzetrigine group will receive a 100 mg loading dose of Suzetrigine, followed by 50mg Q12h for 14 days as an addition to a standardized multimodal pain management pathway. The standardized multimodal pain management pathway consists of treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed).
Standard multimodal control group will receive treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
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