Health TrialsbyHealthPanel

Evaluating Suzetrigine for Pain Control Following TKA

ConditionPostoperative Pain Following Knee Arthroplasty
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth

About this trial

The goal of this clinical trial is to learn if a non-opioid pain medicine called suzetrigine works to treat pain after total knee replacement surgery in adults. It will also learn about the safety of suzetrigine. The main questions it aims to answer are:

Does suzetrigine lower the amount of opioid pain medicine participants use after surgery?

Does suzetrigine have any effect on postoperative patient-reported outcomes, including pain scores, range of motion, length of stay, and KOOS/PROMIS surveys?

Researchers will compare suzetrigine to a placebo to see if suzetrigine works to treat pain after total knee replacement surgery.

Participants will:

Take suzetrigine or a placebo by mouth for 14 days after surgery

Receive standard pain care, including opioid pain medicine only if needed

Report their pain levels using short daily surveys

Attend routine follow-up visits after surgery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Scheduled for elective, unilateral primary total knee arthroplasty

Able to tolerate oral medications after surgery

Disqualifiers

Revision or bilateral total knee arthroplasty

American Society of Anesthesiologists (ASA) physical status classification greater than 3

Severe renal impairment (estimated glomerular filtration rate less than 15 mL/min/1.73 m²)

Severe hepatic impairment (Child-Pugh Class C)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine

    Drug

    Suzetrigine is an oral, non-opioid pain medication that works by blocking specific sodium channels involved in pain signaling. In this study, participants assigned to the suzetrigine group will receive a 100 milligram oral dose in the preoperative area, immediately prior to undergoing the procedure, followed by 50 milligrams taken by mouth twice daily for 14 days after surgery. Suzetrigine will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.

  • Placebo

    Drug

    The placebo is an oral tablet designed to look like the suzetrigine tablet but contains no active drug. In this study, participants assigned to the placebo group will receive a tablet in the preoperative area immediately prior to the procedure, followed by placebo tablets taken by mouth twice daily for 14 days after surgery. The placebo will be given in addition to standard postoperative pain care, including acetaminophen, nonsteroidal anti-inflammatory drugs when appropriate, and opioid pain medication only if needed for breakthrough pain.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: Suzetrigine/JournavxExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid Usage

MME of opioid usage

Time frame
2 weeks

Secondary outcomes

1

Numeric Pain Rating Scale Scores

Pain will be measured using the Numeric Pain Rating Scale (NPRS), a patient-reported pain scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain. NPRS scores will be collected daily for the first 14 days after surgery and summarized over the 2-week postoperative period.

Time frame
2 Weeks
2

Range of Motion

Knee range of motion will be assessed using goniometric measurement of knee flexion, performed by a trained care provider during routine postoperative evaluations. Range of motion reflects the degree of knee movement achieved after surgery. Greater range of motion indicates better functional recovery. Measurements will be obtained at discharge and at the 2-week postoperative visit.

Time frame
2 Weeks
3

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

Pain-related interference with daily activities will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference questionnaire. This is a standardized patient-reported outcome measure that evaluates the extent to which pain interferes with physical, social, and emotional functioning. Higher scores indicate worse pain interference.

Time frame
2 Weeks
4

Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Score

Physical function will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function questionnaire, a validated patient-reported measure of mobility and functional ability. Higher scores indicate better physical function.

Time frame
2 Weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AdventHealth

Lead sponsor

American Association of Hip and Knee Surgeons

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: