Suzetrigine for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a pain relief plan using suzetrigine can control pain after transvaginal pelvic reconstructive surgery as effectively as the usual care, which includes opioids. Suzetrigine targets pain signals outside the brain, potentially resulting in fewer side effects compared to opioids. Participants will receive either suzetrigine with other non-opioid painkillers or the standard treatment, which includes opioids if needed. This study is suitable for adults undergoing this type of surgery who do not regularly use opioids or have certain chronic pain conditions. As a Phase 4 trial, this research seeks to understand how the already FDA-approved suzetrigine benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use strong CYP3A4 inhibitors within 7 days before surgery or if you have chronic opioid use.
What is the safety track record for suzetrigine?
Research has shown that suzetrigine is generally well-tolerated by patients. In one study, 90.9% of patients rated suzetrigine's effectiveness as excellent, very good, or good, indicating that most found it effective without major issues. Another study found that 90.9% of patients recovered without needing opioids, which often cause side effects.
These studies also demonstrated that suzetrigine provided reliable pain relief without the neurological side effects associated with opioids. There was no significant increase in unwanted side effects, suggesting the treatment is safe for most people. This is promising for those considering participation in a trial with suzetrigine.12345Why are researchers enthusiastic about this study treatment?
Suzetrigine is unique because it is part of a multimodal approach that could reduce reliance on opioids for managing postoperative pain. While standard care often includes opioids, which can be addictive and have several side effects, suzetrigine offers a different strategy by being administered as a loading dose followed by a consistent dosing schedule with acetaminophen and ibuprofen. Researchers are excited about suzetrigine as it may provide effective pain relief with fewer side effects and lower risk of addiction compared to traditional opioid-inclusive regimens.
What evidence suggests that suzetrigine might be an effective treatment for postoperative pain?
Research has shown that suzetrigine is a promising non-opioid option for managing post-surgical pain. In earlier studies, 90.9% of patients rated the pain relief from suzetrigine as excellent or good, with many recovering without needing opioids. This trial will compare a suzetrigine-based regimen to a standard opioid-inclusive analgesic regimen. Suzetrigine blocks certain pain pathways, reducing pain without the usual side effects of opioids. Data from past trials indicate that suzetrigine effectively controls pain after various surgeries, such as bunion removal and plastic surgery. Overall, suzetrigine has proven safe and effective in providing pain relief while reducing the need for opioids.12467
Who Is on the Research Team?
A Lenore Ackeman, MD, PhD
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) having planned transvaginal pelvic reconstructive surgery at UCLA, who can give written consent and are expected to go home the same day or after a short stay.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days.
Follow-up
Participants are monitored for pain intensity, opioid consumption, adverse events, and functional recovery at 48 hours, 1 week, and 6 weeks postoperatively.
What Are the Treatments Tested in This Trial?
Interventions
- Suzetrigine
Trial Overview
The study compares pain control using suzetrigine (a new non-opioid pain medicine), acetaminophen, and ibuprofen versus standard care that includes opioids like tramadol or oxycodone. Participants are randomly assigned to different treatment groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.
Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
Citations
Efficacy and Safety of Suzetrigine for Acute Postoperative ...
These findings suggest that suzetrigine offers effective and well-tolerated analgesia, supporting its role in opioid-sparing postoperative pain ...
2.
pharmacypracticenews.com
pharmacypracticenews.com/Online-First/Pain/Article/05-26/Pain-Suzetrigine-Data-Reveal-Reduced-Postoperative-Opioids/80616Pain Suzetrigine Data Reveal Reduced Postoperative ...
The results revealed 90.9% of patients rated the effectiveness of suzetrigine as excellent, very good, or good (95% CI, 83.1%-95.7%), while ...
The effectiveness and value of suzetrigine for moderate ...
Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in ...
4.
pharmacytimes.com
pharmacytimes.com/view/data-support-suzetrigine-s-use-for-acute-pain-following-plastic-surgical-proceduresData Support Suzetrigine's Use for Acute Pain Following ...
Phase 4 data show suzetrigine controls post–plastic surgery pain, keeping nearly 91% of patients opioid free with good pain ratings and ...
Association of Suzetrigine With Postoperative Outcomes ...
A novel non-opioid analgesic, Suzetrigine, may be able to effectively manage postoperative pain without some of the psychological and economic ...
6.
anesthesiologynews.com
anesthesiologynews.com/Pain-Medicine/Article/05-26/Pain-Suzetrigine-Data-Reveal-Reduced-Postoperative-Opioids/80490Pain Suzetrigine Data Reveal Reduced Postoperative ...
SALT LAKE CITY—New data show that suzetrigine (Journavx, Vertex) results in opioid-free recovery for 90.9% of patients treated with the nonopioid inhibitor ...
Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...
These randomized, double-blind studies assessed the analgesic efficacy of suzetrigine in postoperative pain management following bunionectomy ...
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