A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine

NCT ID: NCT07257133

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-03-31

Brief Summary

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.

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Suzetrigine

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

Group Type: EXPERIMENTAL

Suzetrigine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Deanna C. Menapace

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deanna C. Menapace, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

25-004867

Identifier Type: -

Identifier Source: org_study_id