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NCT07905404

PHASE4

Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn whether suzetrigine (Journavx®), when added to standard multimodal pain management, can reduce opioid use while providing adequate pain control in adults undergoing surgery for an acute hip fracture. The study will enroll adults aged 18 years or older with femoral neck, intertrochanteric, pertrochanteric, or subtrochanteric hip fractures requiring operative treatment at Beth Israel Deaconess Medical Center. Although enrollment is open to adults aged 18 years and older, the study population is expected to consist predominantly of older adults. The main questions the study aims to answer are: * Does treatment with suzetrigine as part of multimodal pain therapy reduce postoperative opioid consumption, measured as morphine milligram equivalents (MME), during the index hospitalization through 72 hours after surgery or hospital discharge, whichever occurs first? * Does suzetrigine provide effective postoperative pain control and have an acceptable safety and tolerability profile in adults undergoing hip fracture surgery? Researchers will compare participants receiving suzetrigine plus standard multimodal analgesia with matched historical BIDMC patients who underwent similar hip fracture surgery between 2020 and 2025 and received standard multimodal analgesia without suzetrigine. Historical controls will be matched on factors including age, sex, fracture type, surgery type, surgeon, ASA class, opioid-naïve status, regional anesthesia, and relevant comorbidities. Participants in the prospective study will: * Receive a 100-mg oral loading dose of suzetrigine before surgery, followed by 50 mg orally every 12 hours for up to 14 days or until pain resolves, whichever occurs first. * Receive standard multimodal pain management, which may include acetaminophen, nonsteroidal anti-inflammatory medications when appropriate, regional anesthesia, and rescue opioid medication as clinically needed. * Complete pain assessments during hospitalization and at follow-up time points, with opioid use recorded and converted to MME. * Complete follow-up assessments at approximately Days 7, 14, and 28 after surgery, including pain, medication use, adverse events, treatment adherence, and patient-reported outcomes. * Record study medication use, missed doses, rescue opioid use, and adverse events after hospital discharge when applicable.

Official title: Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture: A Single-Arm Prospective Study Compared to Historical Controls (STRIDE-HIP Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-01-05

Completion Date

2028-07-30

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Hip Fractures (ICD-10 72.01-72.2)Post Operative Analgesia

Interventions

DRUG

Suzetrigine (Journavx)

Suzetrigine is a non-opioid analgesic that selectively inhibits the Nav1.8 voltage-gated sodium channel. Participants will receive a 100 mg oral loading dose followed by 50 mg orally every 12 hours. Treatment may continue for up to 14 days from the first dose or until pain resolves, whichever occurs first. Dose modification or discontinuation may occur when clinically indicated based on hepatic function, concomitant medications, adverse events, or other safety considerations. Suzetrigine is administered in addition to standard multimodal postoperative pain management.

Inclusion Criteria * Age 18 years or older at the time of surgery. * Acute hip fracture requiring operative treatment, including: * Femoral neck fracture * Intertrochanteric fracture * Pertrochanteric fracture * Subtrochanteric fracture * Treatment with arthroplasty or another operative hip fixation construct at BIDMC. * Acute fracture with injury-to-surgery interval of 14 days or less. * Baseline pain score of 5 or greater on a 0-10 Numeric Rating Scale (NRS) before surgery, indicating moderate-to-severe acute pain. * Ability to self-report pain using the NRS, or, where cognitive impairment limits reliable NRS reporting, ability to be assessed using the Pain Assessment in Advanced Dementia (PAINAD) scale. * Ability to swallow oral tablets. * Willing and able to provide written informed consent. * Ability to comply with study procedures and follow-up requirements. Exclusion Criteria * Pathologic fracture due to malignancy, infection, or metabolic bone disease other than osteoporosis. * Open fracture. * Periprosthetic fracture around a pre-existing hip arthroplasty. * Multiple trauma or multiple low-energy fractures involving either lower extremity. * Known allergy, hypersensitivity, intolerance, or contraindication to suzetrigine. * Concurrent use of a strong CYP3A4 inhibitor that cannot be safely discontinued or substituted. * Severe hepatic impairment, including Child-Pugh Class C. * End-stage renal disease with eGFR \<15 mL/min/1.73 m² or current dialysis. * Active substance use disorder involving alcohol or illicit drugs within the prior 24 months. * Long-term opioid therapy for more than 30 days within the 90 days before fracture. * Long-term analgesic therapy, including suzetrigine, for more than 30 days within the 90 days before fracture. * Pre-existing dependence on narcotic or other pain medications. * Concurrent painful condition likely to require analgesic treatment during the postoperative period and confound assessment of hip-fracture-related pain. * Clinically significant intraoperative or perioperative event, such as excessive bleeding or acute sepsis, that renders the participant medically unstable or complicates postoperative assessment. * Inability to take oral medication during the perioperative period, including prolonged NPO status, bowel obstruction, or swallowing disorder. * Pregnancy or breastfeeding at enrollment. * Concurrent participation in another interventional clinical trial. * Receipt of another investigational drug within 30 days or 5 elimination half-lives, whichever is longer, before study-drug administration. * Planned use of another investigational product or procedure during study participation. * Previous participation in a suzetrigine study. * Active delirium at the time of consent. * Cognitive impairment that, in the investigator's judgment, prevents the participant from personally understanding the study and providing valid informed consent. * Clinically significant unstable cardiovascular status, including acute coronary syndrome, myocardial infarction, decompensated heart failure, cardiogenic shock, hemodynamically significant arrhythmia requiring urgent treatment, or other persistent cardiovascular/hemodynamic instability. * Any other condition that, in the investigator's judgment, would compromise participant safety or data integrity.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States