Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT07226700
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing primary THA (posterior approach) with participating surgeons
* Age 18 to 80 years old
* Planned discharge to home
* Planned use of neuraxial anesthesia
* American Society of Anesthesiologists (ASA) Physical Status 1 - 3
Exclusion Criteria:
* ASA greater than 3
* Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery)
* History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator)
* History of QT prolongation
* Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device
* Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse
* Inability to comply with any component of the study protocol
* Younger than 18 or greater than 80 years old at the time of enrollment
* Patient already on Suzetrigine
* Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease/Child Pugh B or C, use of strong CYP3 inhibitors or inducers)
* Contraindications to neuraxial anesthesia or any other part of the study protocol
* Participation in another investigational drug or device study
* Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07226700
Study Brief:
Protocol Section:
NCT07226700