Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at Orange, California
Dates
study started
study ends around
Principal Investigator
by Peter Hsiue, MDSteven Yang, MD

Description

Summary

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.

Keywords

Total Knee Arthroplasty, Suzetrigine

Eligibility

You can join if…

Open to people ages 18-80

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

You CAN'T join if...

  • 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

Location

  • UCI Health Medical Center
    Orange California 92868 United States

Lead Scientists at UC Irvine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT07928011
Phase
Phase 4 Knee Replacement Research Study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated