Suzetrigine for Postoperative Pain After Skin Cancer Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized clinical trial will compare suzetrigine with standard analgesia for postoperative pain management after skin cancer surgery.
Adults undergoing Mohs micrographic surgery or wide local excision for cutaneous malignancy or a skin-cancer precursor lesion of the head and neck will be randomized to suzetrigine monotherapy or scheduled acetaminophen plus ibuprofen for 72 hours after surgery. The study uses a double-blind, double-dummy design, and breakthrough oxycodone may be prescribed in either arm on request after same-day clinical assessment.
The primary objective is to determine whether suzetrigine controls acute postoperative pain as well as scheduled acetaminophen plus ibuprofen during the first 24 hours after the first dose. Secondary outcomes include rescue opioid consumption, pain through 48 and 72 hours, satisfaction with pain control, functional recovery, adverse events, surgical bleeding, wound-healing complications, and blinding integrity.
Who Is on the Research Team?
Chandler W Rundle, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults having Mohs surgery or wide local excision on the head or neck to treat skin cancer or a related lesion. Participants must be able to take part in pain management studies after their procedure.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen Plus Ibuprofen
- Suzetrigine
Trial Overview
The study compares suzetrigine alone versus regular doses of acetaminophen plus ibuprofen for managing pain during the first three days after skin cancer surgery. Patients are randomly assigned and neither they nor doctors know which treatment they're getting.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will receive suzetrigine monotherapy for 72 hours after Mohs micrographic surgery or wide local excision. Participants will receive a 100 mg loading dose in clinic after surgery, followed by 50 mg every 12 hours through 72 hours, with matching placebo capsules at intervening dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.
Participants randomized to this arm will receive the standard analgesic regimen of acetaminophen 1000 mg every 8 hours plus ibuprofen 400 mg every 6 hours for 72 hours after Mohs micrographic surgery or wide local excision, with matching placebo capsules at suzetrigine dosing times to preserve blinding. Breakthrough oxycodone may be prescribed on request after same-day clinical assessment.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Minnesota Cancer Clinical Trials Network
Collaborator
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