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Suzetrigine Versus Standard Analgesia After Skin Cancer Surgery

ConditionsPostoperative PainAcute PainSkin CancerCutaneous MalignancyMohs Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine

    Drug

    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.

  • Acetaminophen Plus Ibuprofen

    Drug

    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.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: SuzetrigineExperimental treatment 1 intervention
Group B: Acetaminophen Plus IbuprofenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 24 Hours

The primary endpoint is the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10 over the first 24 hours after the first study dose, expressed as change from baseline. The endpoint will be tested for non-inferiority of suzetrigine compared with scheduled acetaminophen plus ibuprofen.

Time frame
Baseline through 24 hours after first study dose

Secondary outcomes

1

Rescue Opioid Consumption Within 24 Hours

Rescue opioid consumption will be measured as total oxycodone use in morphine milligram equivalents within the first 24 hours after the first study dose.

Time frame
Baseline through 24 hours after first study dose
2

Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 48 Hours

Pain over 48 hours will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.

Time frame
Baseline through 48 hours after first study dose
3

Time-Averaged Numeric Pain Rating Scale Area Under the Curve Over 72 Hours

Pain over the 72-hour treatment course will be assessed using the time-averaged area under the curve of Numeric Pain Rating Scale scores from 0 to 10, expressed as change from baseline.

Time frame
Baseline through 72 hours after first study dose
4

Maximum Numeric Pain Rating Scale Score

Maximum postoperative pain will be assessed using the highest Numeric Pain Rating Scale score reported during the 72-hour treatment course.

Time frame
Baseline through 72 hours after first study dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Minnesota Cancer Clinical Trials Network

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: