Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07843134

PHASE4

Suzetrigine Versus Standard Analgesia After Skin Cancer Surgery

Sponsor: University of Minnesota

View on ClinicalTrials.gov

Summary

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.

Official title: Non-Opioid Postoperative Pain Management in Skin Cancer Surgery: A Randomized Trial of Suzetrigine Versus Standard Analgesia in Minnesota

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2027-04-01

Completion Date

2029-07-30

Last Updated

2026-09-25

Healthy Volunteers

Conditions

Postoperative Pain Acute Pain Skin Cancer Cutaneous Malignancy Mohs Surgery

Interventions

DRUG

Suzetrigine

Participants will receive suzetrigine 100 mg orally once as a loading dose in clinic after surgery, followed by suzetrigine 50 mg orally every 12 hours through 72 hours. Matching placebo capsules will be used at intervening dosing times to preserve blinding.

DRUG

Acetaminophen Plus Ibuprofen

Participants will receive acetaminophen 1000 mg orally every 8 hours plus ibuprofen 400 mg orally every 6 hours through 72 hours after surgery. Matching placebo capsules will be used at suzetrigine dosing times to preserve blinding.

Inclusion Criteria: * Age 18 years or older * Biopsy-proven cutaneous malignancy of the head or neck, including melanoma, melanoma in situ, cutaneous squamous cell carcinoma, or basal cell carcinoma, or a biopsy-confirmed precursor lesion to skin cancer requiring excision * Planned treatment by Mohs micrographic surgery or wide local excision * Surgical defect requiring intermediate layered closure, complex closure, adjacent tissue transfer, or full-thickness skin graft * Able to take oral medications * Access to an electronic diary device, or willingness to use a paper backup * Able to provide written informed consent, with English, Hmong, or Somali language materials and interpreter support available Exclusion Criteria: * Contraindication to ibuprofen, including active peptic ulcer disease, history of gastrointestinal bleeding, estimated glomerular filtration rate below 30 mL/min/1.73 m², or NSAID hypersensitivity * Moderate or severe hepatic impairment, defined as Child-Pugh Class B or C * Chronic heavy alcohol use * Known hypersensitivity to acetaminophen * Known hypersensitivity to opioids * Severe untreated obstructive sleep apnea or other respiratory compromise that would make a short course of breakthrough oxycodone unsafe * Concurrent use of a benzodiazepine or other sedative-hypnotic * Concurrent use of a strong or moderate CYP3A inhibitor, or a strong or moderate CYP3A inducer * Regular opioid use in the prior 30 days, meaning opioid use on most days or any standing opioid prescription * Body weight below 50 kg * Prior major bleeding on a nonsteroidal anti-inflammatory drug, or an active bleeding disorder * Pregnancy or breastfeeding * Prior adverse reaction to suzetrigine * Cognitive impairment precluding completion of patient-reported outcomes * Participation in another interventional trial within 30 days * Children * Fetuses * Neonates * Prisoners * Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent * Employees of the researcher * Students of the researcher * Individuals approached in emergency or acutely stressful settings

Locations (3)

M Health Fairview Clinic - Maple Grove

Maple Grove, Minnesota, United States

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota, United States

M Health Fairview Clinic - Wyoming

Wyoming, Minnesota, United States