A Phase 4 interventional study of Suzetrigine in Total Knee Arthroplasty, sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of California, Irvine · Phase 4, Interventional, and Treatment
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.
University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
Drug: Suzetrigine
100 mg loading dose of Suzetrigine, followed by 50mg every 12 hours for 14 days as an addition to a standardized multimodal pain management pathway.
Participant enrollment
Enrollment rates
Time frame: At enrollment
Protocol adherence
Protocol adherence rates
Time frame: Within 14 days
Data collection
Completeness of data collection
Time frame: At 14 days
Primary Clinical Outcome: Opioid consumption
Total cumulative opioid consumption in milligrams morphine equivalents (MME) within the study period
Time frame: Within 14 days
Pain
Numeric Pain Rating Scale (NPRS): Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: At 14 days
First day of walking unassisted
Time frame: Within 14 days
Barthel Index for Activities of Daily Living (ADL)
Cumulative score ranges from 0 to 100, where 0 indicates complete dependence and 100 signifies total independence
Time frame: At 14 days
Knee injury and Osteoarthritis Outcome Score (KOOS)
0 represents extreme knee problems, and 100 represents no knee problems
Time frame: At 14 days
Knee range of motion
Clinical assessment
Time frame: At 14 days
Time to opioid cessation
Time frame: Within 14 days
Opioid prescription renewal
Time frame: Within 14 days
Incidence of opioid-related adverse events
Time frame: Within 14 days
Start is estimated for Jan 2027; primary completion for Mar 2027, 2 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Suzetrigine
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