NCT07219888

Comparison of Suzetrigine and Oxycodone for Postoperative Pain After Primary Total Knee Arthroplasty

Comparison of Suzetrigine and Oxycodone for Postoperative Pain and Analgesic Requirements After Primary Total Knee Arthroplasty: a Prospective, Randomized Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose this study is determine whether postoperative oral dosage of suzetrigine is effective at controlling postoperative pain and reducing analgesic requirements following primary total knee arthroplasty (TKA) versus a control group of TKA patients receiving postoperative Oxycodone.

Detailed description

The purpose of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary total knee arthroplasty (TKA) and to determine whether postoperative administration of oral dosage of suzetrigine is effective at reducing postoperative pain versus a control group of patients receiving oral dosage of oxycodone only following primary total knee arthroplasty. The primary objective will be to compare the amount of postoperative narcotics utilized and postoperative VAS pain levels. The secondary objective will be to compare variables of patient functionality and other patient-reported outcome measures. The main questions it aims to answer are: 1. What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty? 2. Will the study results demonstrate the effectiveness and safety of oral suzetrigine after primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare suzetrigine to a standard postoperative pain control regimen (Oxycodone) to see if suzetrigine is equivalent or more effective at reducing opioid consumption and postoperative pain following primary total knee arthroplasty. Participants will: * be randomized into one of two groups * undergo a primary TKA * complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop

Conditions

• Osteoarthritis (OA) of the Knee

Interventions

Type	Name	Description
DRUG	oral suzetrigine	patient receives a two-week supply of oral suzetrigine upon discharge
DRUG	oral Oxycodone	Patient will receive a two-week supply of oral Oxycodone upon discharge

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-30
• Completion: 2026-05-29
• First posted: 2025-10-22
• Last updated: 2025-10-28

Regulatory

• FDA-regulated drug study