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Enrolling by invitation NCT07575230

Suzetrigine vs Norco-postoperative Mohs Pain

Phase IV Interventional Cutaneous Tumors Mohs Micrographic Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norco 5Mg-325Mg Tablet, Suzetrigine.
Who it may be relevant to
Registry conditions: Cutaneous Tumors, Mohs Micrographic Surgery. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Non-Opioid Pain Management After Mohs Reconstruction: An Investigator-Initiated, Prospective, Randomized Clinical Trial of Suzetrigine vs Hydrocodone/Acetaminophen

Overview

To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery.

Detailed description

This study is a randomized, controlled trial that is evaluating the safety and efficacy of suzetrigine as a postoperative pain medication compared to the standard of care Hydrocodone/Acetaminophen in patients undergoing Mohs micrographic surgery (MMS) who are at high-risk for postoperative pain and opioid use. The goal is to reduce opioid prescription use and give patients a non-opioid pain medication option for particularly painful surgeries. Patients will be randomized into one of two groups, one group will receive the interventional medication and the other the standard of care medication.

Interventions

  • Drug Norco 5Mg-325Mg Tablet
    Standard of care drug
  • Drug Suzetrigine
    Control Drug

Primary outcome measures

  • Change in need for opioid medication for pain management after Mohs micrographic surgery [Time frame: 48hours post surgery]
Secondary outcome measures (3)
  • Patient-reported adequacy of pain control [Time frame: 48hours post surgery]
  • Rescue pain management use [Time frame: 48hours post surgery]
  • Adverse Events [Time frame: 3 days after surgery]

Eligibility criteria

Inclusion criteria

  • adults between the age of 18-89
  • individuals who have a cutaneous tumor treated by MMS

Exclusion criteria

  • individuals younger than 18 and older than 89
  • individuals taking medications that interact with the CYP3A (Cytochrome P450 3A) pathway
  • individuals with liver disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor University Medical Center — Dallas

Publications

  • Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs microg PMID 22959232
  • Phillips, Shay, et al.

Identifiers

NCT: NCT07575230 · 025-413

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗