Suzetrigine for Postoperative Pain After Skin Cancer Surgery

Not yet recruiting at 2 trial locations
AF
CW
Overseen ByChandler W Rundle, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Minnesota
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?

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?

CW

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

Able to take oral medications
Able to provide written informed consent, with English, Hmong, or Somali language materials and interpreter support available
I am 18 years old or older.
See 4 more

Exclusion Criteria

Known hypersensitivity to acetaminophen
Fetuses
Chronic heavy alcohol use
See 20 more

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

Group I: SuzetrigineExperimental Treatment1 Intervention
Group II: Acetaminophen Plus IbuprofenActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Minnesota Cancer Clinical Trials Network

Collaborator

Trials
1
Recruited
400+