Suzetrigine for Pain Management After Broken Hip Surgery

(STRIDE-HIP Trial)

AN
AM
Overseen ByAlireza Mirahmadi, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

I had hip surgery or a hip implant at BIDMC.
Ability to comply with study procedures and follow-up requirements
I have a recent hip fracture that needs surgery.
See 6 more

Exclusion Criteria

I have a broken bone near my hip replacement.
I have had a bone fracture caused by cancer, infection, or a bone disease (not osteoporosis).
I have a broken bone with the fracture exposed through the skin.
See 21 more

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

Group I: Suzetrigine + Standard Multimodal AnalgesiaExperimental Treatment1 Intervention
Group II: Matched Historical ControlsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Vertex Pharmaceuticals Incorporated

Industry Sponsor

Trials
267
Recruited
36,100+
Dr. David Altshuler profile image

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani profile image

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology