Suzetrigine for Total Hip Replacement
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how well a new drug, Suzetrigine, aids individuals undergoing total hip replacement. The goal is to determine if Suzetrigine can reduce the need for opioids, which are painkillers with unpleasant side effects and addiction risks. Participants will receive either Suzetrigine or a placebo (a pill with no active drug) for seven days, starting just before their surgery. This trial suits individuals having their first hip replacement surgery, who will return home after surgery, and do not regularly use opioids. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic opioids or certain medications that interact with Suzetrigine, you may not be eligible to participate.
Is there any evidence suggesting that Suzetrigine is likely to be safe for humans?
Research has shown that Suzetrigine has been tested for safety in treating sudden pain. In one study involving about 250 people, Suzetrigine was used after various types of surgery. The results revealed no major safety concerns, suggesting it is generally well-tolerated. However, some individuals might still experience side effects. Importantly, Suzetrigine is not an opioid, so it does not carry the usual risks of addiction or drowsiness associated with opioid painkillers. This could make it a safer option for managing post-surgical pain.12345
Why do researchers think this study treatment might be promising?
Suzetrigine is unique because it offers a new approach to managing pain and recovery after total hip replacement. Unlike traditional treatments, which often rely on opioids or NSAIDs, Suzetrigine works by targeting specific pain pathways, potentially reducing the need for these medications and their associated side effects. Researchers are excited about Suzetrigine because it could lead to faster recovery times and improved mobility, making the post-surgery experience smoother and more comfortable for patients.
What evidence suggests that Suzetrigine might be an effective treatment for total hip replacement?
Research has shown that Suzetrigine, which participants in this trial may receive, effectively relieves pain without using opioids. It has helped manage pain after surgeries, such as hip replacements, and for conditions like complex regional pain syndrome. Some studies suggest it can reduce the need for opioids, which are strong painkillers that may cause side effects like drowsiness and nausea. However, experts continue to discuss how it compares to other pain treatments. Despite this, Suzetrigine remains a promising option for managing pain without the risks associated with opioid drugs.14678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who are having their first total hip replacement via the posterior approach, plan to go home after surgery, and will have neuraxial anesthesia. They should be in relatively good health (ASA status 1-3).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Suzetrigine or placebo for seven days, with a loading dose administered prior to surgery
Immediate Postoperative Monitoring
Participants' opioid consumption and pain levels are monitored for 48 hours post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at various intervals
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
Trial Overview
The study tests Suzetrigine against a placebo in managing pain after hip replacement surgery. The goal is to see if it can reduce opioid use post-surgery. Participants will randomly receive either Suzetrigine or a placebo for seven days.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital for Special Surgery, New York
Lead Sponsor
Citations
NCT07226700 | Suzetrigine in Total Hip Arthroplasty
The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).
Between promise and peril: role of suzetrigine as a non-opioid ...
Despite recent approval from the US Food and Drug Administration, the clinical benefits of suzetrigine remain modest and contested.
Hip Replacement Clinical Research Trials
In this study, patients undergoing primary total hip arthroplasty will be randomized to receive Suzetrigine or placebo for seven days, with the loading dose ...
Suzetrigine as a Non-Opioid Analgesic: Balancing Promise ...
While the data show that suzetrigine is effective as an analgesic, the degree of additional clinical impact to modern multimodal pain pathways ...
initial prescribing practices of suzetrigine for patients with ...
Patients with chronic pain were prescribed Suzetrigine to manage acute post-procedural pain, complex regional pain syndrome two months following ...
219209Orig1s000 - accessdata.fda.gov
the Safety and Effectiveness of Suzetrigine for Acute Pain (Study 107) provided uncontrolled safety data over a treatment period of up to 14 days. Study 107 ...
Healthcare Professionals: JOURNAVX® (suzetrigine) for ...
IMPORTANT SAFETY INFORMATION. CONTRAINDICATIONS. Use of JOURNAVX with strong CYP3A inhibitors is contraindicated. WARNINGS AND PRECAUTIONS. INDICATION. JOURNAVX ...
FDA Approves Non-Opioid Pain Medication Suzetrigine ...
Vertex also submitted safety data from a study of about 250 people who received suzetrigine after experiencing pain from other types of surgery, ...
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