Post-operative Pain, Total Knee Replacement Surgery
Conditions
Brief summary
This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.
Interventions
DRUGSuzetrigine
Suzetrigine is a new pain medication that works by inhibiting sodium channels (NAV 1.8) on pain nerves in the peripheral nervous system. By inhibiting this sodium channel on peripheral nerves it blocks pain signals from reaching the spinal cord and brain, decreasing pain.
DRUGPlacebo
Matching placebo
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Pharmacy will be responsible for randomizing study participants to either the treatment arm or placebo (non-treatment) arm. Both treatment and placebo medications will be made to look identical so that only the pharmacy will know which arm the participant was assigned to.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in this study, an individual must meet all of the following criteria: * Adults 18-85 years old * Scheduled to undergo total knee replacement surgery * All genders
Exclusion criteria
Any individual who meets any of the following criteria will be excluded from participation in this study: * American Society of Anesthesiology Physical Classification (ASA) Class V * Urgent or emergent surgery * Contraindications to administration of Suzetrigine: * Patients who take moderate-to-severe CYP3A inhibitors (such as Ritonavir, Voriconazole, and Clarithromycin) * Patients who take moderate-to-severe CYP3A inducers (such as Phenytoin, Carbamazapine, and Rifabutin) * Patients with moderate to severe hepatic impairment * History of substance use disorder or chronic opioid use or alcohol abuse * Reoperation * Patient refusal or inability to consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 5 days | Total amount of opioid consumption required post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog pain scale | 5 days | Participants perceived post-operative pain measured daily using the visual analog scale for pain. Total score is 0 to 10, higher score indicates more pain. |
Countries
United States
Contacts
CONTACTMichael Lazar, MD
CONTACTHimani Bhatt, DO
PRINCIPAL_INVESTIGATORMichael Lazar, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed