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.
The objective of the study is to determine the effect suzetrigine has on postoperative pain, opioid use, sleep quality, and patient satisfaction when it is used as part of a multimodal pain regimen prescribed to patients after total knee arthroplasty. The study will enroll eligible participants who are scheduled to receive a total knee arthroplasty. Participants will first consent to participate in the research study. They will then be asked to complete certain baseline measurements and instructed to begin wearing a device on their wrist that will quantify their activity and sleep quality ("sleep tracker"). They will complete a baseline KOOS JR survey. There are no additional surveys or diaries to complete pre-operatively. They will receive a suzetrigine prescription (the intervention) on the day of their total knee arthroplasty after the procedure has been completed in addition to the standard of care pain control regimen after surgery. They will complete a diary for a set time after surgery, and subject will continue to wear the sleep tracker for up to 2 weeks post-surgery. They will complete a daily sleep diary for 14 days after surgery to document sleep duration, sleep quality, nighttime awakenings, and other related factors. They will also complete a diary for 14 days after surgery that asks them to report their pain level 3 times daily, their nausea level 3 times daily, and the number of narcotic pills taken daily, and continue to wear their activity and sleep tracker. They will be asked to complete a pill tracking chart to confirm they are taking Journavx as directed for 14 days after surgery. 1 week and 2 weeks after surgery, they will complete a survey that quantifies their sleep related impairment. Approximately 3 months after surgery, subjects will complete another survey. Participants will have interactions with the study team until approximately 3 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Emory Clinic
Atlanta, Georgia, United States
Emory Clinic at Executive Park
Atlanta, Georgia, United States
Emory Orthopaedics and Spine Center
Atlanta, Georgia, United States
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
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
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
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
Total sleep time
Total sleep time will be collected using actigraphy during postoperative days 0-14.
Time frame: Day 0-14 post-operative
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
Sleep latency
Sleep latency will be measured by recording the time from "lights out" to sleep onset, using actigraphy during postoperative days 0-14.
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Time frame: Day 0-14 post-operative
Wake after sleep onset (WASO)
Wake after sleep onset (WASO) will be assessed using actigraphy during postoperative days 0-14.
Time frame: Day 0-14 post-operative
EQ5D Score
Health-related quality of life measure using the EQ-5D questionnaire, which assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted into a summary index score, where 1 represents full health and 0 represents death (higher values indicating better health status).
Time frame: 3 months post-operative
KOOS Jr Score
Patient-reported knee function assessed using the Knee Injury and Osteoarthritis Outcome Score Junior (KOOS Jr). The KOOS Jr is a validated short-form instrument derived from the full KOOS, designed to evaluate knee health based on key items related to pain, symptoms, and physical function. Scores are transformed to a 0 to 100 scale, with higher scores indicating better knee function and fewer symptoms.
Time frame: Baseline, 3 months post-operative