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Role of Suzetrigine as a Part of a Multimodal Regimen to Reduce Pain and Opioid Use After Total Knee Arthroplasty

ConditionsKnee ArthritisKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-95
SponsorEmory University

About this trial

This study is a prospective, single-arm interventional trial enrolling patients undergoing total knee arthroplasty (TKA) for knee arthritis. All participants will receive Suzetrigine (brand name Journavx by Vertex Pharma) as part of a standardized multimodal perioperative analgesic regimen in addition to standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.

Patients between the ages of 18 and 95 years.

Disqualifiers

Patients with concurrent and significant injuries to other bones or organs.

Patients with local infections.

Minors unable to provide informed consent for participation in the study.

Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Trial design

Design model

Single group

Treatments tested in this trial

  • Suzetrigine

    Drug

    Suzetrigine is an orally administered, selective NaV1.8 voltage-gated sodium channel inhibitor being investigated as a non-opioid analgesic for the treatment of pain through inhibition of pain signal transmission in peripheral sensory neurons.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Suzetrigine Regimen ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean pain intensity score on the Numeric Rating Scale (NRS)

Pain will be measured using a scale from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, using a Visual Analog Pain Scale (VAS-pain). Higher score correlates with worse outcome.

Time frame
Day 0-14 postoperative
2

Average daily opioid consumption

Postoperative opioid consumption will be quantified in morphine milligram equivalents (MME) during postoperative days 0-14.

Time frame
Day 0-14 postoperative
3

Cumulative opioid consumption

Postoperative opioid consumption will be quantified as cumulative MME at 3 weeks and 3 months.

Time frame
3 weeks and 3 months postoperative

Secondary outcomes

1

Nausea scores postoperative

A nausea assessment will be assessed using the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 14.

Time frame
Day 0-14 post-operative
2

Total sleep time

Total sleep time will be collected using actigraphy during postoperative days 0-14.

Time frame
Day 0-14 post-operative
3

Sleep efficiency

Sleep efficiency will be measured by recording the ratio of time asleep to time in bed, using actigraphy during postoperative days 0-14.

Time frame
Day 0-14 post-operative
4

Sleep latency

Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.

Time frame
Day 0-14 post-operative

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

Vertex Pharmaceuticals Incorporated

Collaborator

Source ClinicalTrials.gov

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