Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
Suzetrigine vs. Standard Care Rescue Medication in TKA Patients: A Matched Cohort Study
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.
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.
Inclusion Criteria:
Exclusion Criteria:
ortho_research@endeavorhealth.org847-570-1572