A Pilot Randomized Controlled Trial of Suzetrigine as an Adjunct to Multimodal Analgesia Following Total Knee Arthroplasty

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 4

Age range

18 years - 80 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Adults aged 18 to 80 years
• Diagnosis of knee osteoarthritis
• Scheduled for unilateral TKA
• Willingness to maintain a 14-day medication and pain log

Exclusion Criteria:

• Chronic opioid use
• Severe renal impairment (eGFR \< 30 mL/min) or severe hepatic impairment (Child-Pugh Class C)
• History of active peptic ulcer disease or GI bleeding
• Known allergies to any of the study medications (suzetrigine, acetaminophen, meloxicam, or oxycodone).
• Significant peripheral neuropathy in the operative extremity
• Active history of substance abuse or opioid use disorder

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Other measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University of California, Irvine

Study start

2027-01 Estimated

Primary completion

2027-03 Estimated

Study completion

2027-04 Estimated

First posted

Nov 10, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts