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Enrolling by Invitation

NCT Number: NCT07219888

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

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.

Enrolling by Invitation

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Key information

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UofL Health

Louisville, Kentucky, 40202, United States

About this study

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:

  • What is the efficacy of oral suzetrigine in reducing opioid consumption and postoperative pain following primary total knee arthroplasty?
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age is 21-89 at time of surgery
  • Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
  • Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
  • Patient is able to read and speak English.

Exclusion criteria

  • Patient is under the age of 21
  • Patient's primary diagnosis is not osteoarthritis
  • Patient is unable to read and speak English
  • Contraindication or Hypersensitivity to suzetrigine
  • Pregnant or nursing females
  • Patient has taken opioids within the 90 days prior to enrollment

Treatment and study plan

oral suzetrigine

Drug

patient receives a two-week supply of oral suzetrigine upon discharge

oral Oxycodone

Drug

Patient will receive a two-week supply of oral Oxycodone upon discharge

Primary outcomes

  1. Daily Opioid Use POD 1-14

    Time frame: 2 weeks

    Daily opioid use as measured in MME recorded daily for the first two weeks following TKA

  2. total opioid usage over two weeks

    Time frame: 2 weeks

    total daily opioid usage (as measured in MME) for the first 14 days following TKA

  3. Use of supplemental opioid POD 1-14

    Time frame: 2 weeks

    Average time from initial preop pain control dose to first postop supplemental opioid dose (for participants randomized to Group A, if applicable)

  4. VAS pain score over two weeks

    Time frame: 2 weeks

    VAS (Visual Analogue Scale) pain score measuring highest level of knee pain experienced each day for the first 14 days following TKA. Scale 0-10

  5. Opioid Usage at 6 weeks postop

    Time frame: 6 weeks

    Usage of opioids at 6 weeks postoperatively (Y/N) and if yes, what is daily usage

Secondary outcomes

  1. VAS Pain Score at 6 weeks

    Time frame: 6 weeks

    VAS (Visual Analogue Scale) pain score measuring highest level of knee pain at 6 weeks following TKA. Scale 0-10

  2. KOOS, JR.

    Time frame: preoperatively and 6 weeks (± 2 weeks) postoperatively

    The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. Scoring scale 0-100.

  3. ROM

    Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively

    active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 22, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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