Cutaneous Tumors, Mohs Micrographic Surgery
Conditions
Brief summary
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
Standard of care drug
DRUGSuzetrigine
Control Drug
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are randomized into one of two group: interventional group and control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in need for opioid medication for pain management after Mohs micrographic surgery | 48hours post surgery | Change in mean visual analog scale (VAS; 0-10) pain scores at 24 and 48 hours after surgery with a minimal change in pain score of 1.0 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported adequacy of pain control | 48hours post surgery | Assessment of pain control with use of medication following surgery. |
| Rescue pain management use | 48hours post surgery | Changes in need to use rescue medication for pain management |
| Adverse Events | 3 days after surgery | Evaluation of occurence of adverse events (irregular heart beat, abnormal blood pressure, change in consciousness, or need for urgent care or emergency room visit in the first 3 days after surgery). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStan Tolkachjov, MD
Baylor Medical University Center
Outcome results
None listed