Knee Arthroplasty, Total, Opioid Consumption, Postoperative, Post Operative Pain, Acute
Conditions
Keywords
suzetrigine, knee replacement, opioid, post-operative pain
Brief summary
The purpose of this research is to see if a person having an outpatient total knee replacement will have a difference in their pain and the amount of pain medication (opioids) used after discharge if they are given suzetrigine (a non-opioid pain medicine, also known as Journavx®) in addition to the standard pain medicines usually prescribed. Participants will complete a daily pain and medication diary and survey for up to 14 days post-operatively and on day 30.
Detailed description
The investigators will be conducting a prospective, randomized, matched cohort study. This is an open-label study. 100 participants undergoing outpatient total knee arthroplasty (TKA) at Endeavor Health with orthopaedic surgeon Dr. Bashyal will be enrolled. Participants will be introduced to the study during their pre-operative surgical visit and/or will receive a surgeon-signed information letter about the study in their pre-operative TKA take-home information packet. With approval from the surgeon, participants may also (or instead) be sent a signed recruitment letter via the Endeavor Health messaging system by the research team. Research staff will call eligible participants and explain the study in more detail over the phone and answer any questions. Eligible participants who are still interested in participating will be sent an electronic consent using a dedicated RedCap database that will also be used for participant data collection. Eligible participants will be given time to review the consent and then asked to complete the consent form online should they wish to participate. Enrolled participants will be randomized 1:1 to one of the two study arms using a randomization allocation table generated by the study biostatistician. Participants will be notified of their treatment allocation prior to surgery and will be instructed to collect their filled suzetrigine and/or opioid prescription from Skokie Hospital outpatient pharmacy. Participants will be provided with a pain medication diary to help track their pain score and medications throughout the day. They will then enter their diary responses into REDCap pain and medication surveys sent via email. Participants who miss surveys will be called by the research team and the information will be collected at that time. Participant involvement will cease at day 30 post-operatively and any further information (for data up until 90 days postoperatively) will be taken from the medical record.
Interventions
DRUGSuzetrigine
100mg loading dose of suzetrigine in the immediate pre-operative period followed by 50mg of suzetrigine twice daily for a total of 14 days for post-operative total knee arthroplasty pain
DRUGOpioid standard care pain medicine
Opioid standard care pain medicine prescribed for an outpatient total knee arthroplasty is typically hydrocodone/acetaminophen (Norco), oxycodone (Oxycontin), or tramadol (Ultram) for as needed post-operative pain relief. The exact opioid and dose prescribed will be up to the discretion of the surgeon and based on what is most appropriate for an individual patient.
Sponsors
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* outpatient total knee arthroplasty (TKA) at Endeavor Health performed by orthopaedic surgeon Dr. Bashyal
Exclusion criteria
* Allergy to suzetrigine or any of its ingredients * Contraindication to suzetrigine (eg moderate to severe hepatic impairment, severe renal impairment) * Previous or current suzetrigine prescription * Use of a concomitant medication that is a strong CYP3A inhibitor * Patients unwilling to discontinue use of grapefruit or food and drink containing grapefruit while taking suzetrigine * Pregnant or lactating women * Women taking hormonal contraceptives containing progestins other than levonorgestrel and norethindrone must agree to use barrier contraception (eg condoms) or abstain from intercourse during the study or will be excluded from the study for safety reasons * Pre-operative peripheral nerve stimulation (PNS) system in place * Age \< 18 * Dementia or other mental issue that would interfere with accurate pain and medication reporting * Those unable to consent in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score (Numeric Rating Scale - NRS) | Day 0-14 post-operatively and day 30 | The Numeric Rating Scale (NRS) system is used to measure pain. It is a simple 11-point scale from 0 to 10 for quantifying subjective pain intensity. O means "no pain", 1-3 "mild pain", 4-6 "moderate pain", 7-10 "severe pain" where 10 is the worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption (MME) | Day 0-14 post-operatively and day 30 | Cumulative opioid consumption will be calculated and expressed as morphine milligram equivalents (MME) using a standard opioid conversion table. |
Countries
United States
Contacts
CONTACTShanah Salter, MBBS CCRP
Outcome results
None listed