Suzetrigine for Pain Management After Broken Hip Surgery
(STRIDE-HIP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults aged 18 or older who need surgery for a recent hip fracture (such as femoral neck, intertrochanteric, pertrochanteric, or subtrochanteric fractures) at Beth Israel Deaconess Medical Center. Most participants are expected to be older adults.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine (Journavx)
Trial Overview
The study tests whether adding suzetrigine (Journavx) to standard pain management after hip fracture surgery can reduce the need for opioid painkillers while still controlling pain. Results will be compared with similar patients treated in previous years without suzetrigine.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants undergoing operative treatment for acute hip fracture will receive suzetrigine in addition to standard-of-care multimodal analgesia
Historical controls will be selected at approximately a 2:1 ratio using prespecified clinical matching and propensity-score methods to improve comparability between cohorts. 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Industry Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
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