A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine

Opioid Avoidance In Surgery Through Integrating Suzetrigine: Post-Operative Care Phase Pilot

This prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult patients undergoing elective outpatient facial plastic surgery who receive suzetrigine as part of their standard postoperative analgesic regimen.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Suzetrigine

Detailed Description

Traditional postoperative pain management in facial plastic surgery often relies on opioid analgesics. While effective, their use is associated with adverse effects such as constipation, nausea, vomiting, sedation, respiratory depression, and dependency risk. In the context of the ongoing opioid misuse public health crisis, identifying effective non-opioid alternatives is crucial.

Suzetrigine is a first-in-class oral analgesic that selectively inhibits the voltage-gated sodium channel NaV1.8. These channels are selectively expressed within peripheral pain-sensing neurons and do not have a functional role within the central nervous system (CNS). Unlike opioids, suzetrigine does not cross the blood-brain barrier and avoids CNS side effects such as sedation, respiratory depression, and addiction potential.

In January 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigine for the short-term treatment of moderate-to-severe acute pain in adults. Approval was supported by two Phase 3 randomized controlled trials in patients undergoing abdominoplasty (NCT05558410) and bunionectomy (NCT05553366), both standard models for acute postoperative pain. In these studies, suzetrigine demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen, with a faster onset of meaningful pain relief than placebo and a favorable tolerability profile.

Despite this evidence, there is currently no data on the use of suzetrigine in facial plastic surgery. The integration of suzetrigine into postoperative pain management regimens for this population has the potential to reduce opioid prescription patterns and improve patient outcomes. This single-arm feasibility study aims to describe our early experience with suzetrigine and provide preliminary evidence to inform the feasibility and design of future prospective trials.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years) undergoing elective outpatient facial plastic surgery.
• Able to consent and comply with study procedures.
• Planned postoperative use of suzetrigine per provider discretion.

Exclusion Criteria:

• Age <18.
• Pregnant or breastfeeding.
• Women on hormonal birth control who decline suzetrigine-related counseling.
• Patients using strong CYP3A4 inhibitor medications (i.e. itraconazole, ketoconazole, clarithromycin, ritonavir, and grapefruit juice).
• Known allergy to suzetrigine.
• Vulnerable or protected research populations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Suzetrigine; Patients will receive Suzetrigine in place of opioid medications for post-operative pain management.

Drug: Suzetrigine; Patients will receive suzetrigine instead of the standard of care opioids. The dosing schedule will be: a single oral loading dose of 100 mg suzetrigine, followed by 50 mg every 12 hours starting 12 hours after the first dose. Treatment will begin right after surgery and continue for up to 7 days. All patients will also receive acetaminophen (650 mg every 6 hours) and celecoxib (200 mg every 24 hours) as part of the standard multimodal pain management regimen. Patients experiencing breakthrough pain will be prescribed rescue opioid medication (oxycodone 5 mg every 6 hours as needed) and use will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Number of opioid pills used during the first 7 postoperative days	7 days post-operation
Number of patients with no rescue use	Total number of patients who do not use any rescue opioids postoperatively	7 days post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity score	Pain intensity score during the first postoperative day will be measured by the 1 question Visual Analog Scale for pain. Patients will rank level of pain experienced on a 10 point Likert scale, with 0 = No pain and 10 = Worst pain imaginable.	1 day post-operation

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Deanna C. Menapace, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Facial plastic surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: 25-004867

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No