Suzetrigine for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.
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
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