A Study Of Opioid Avoidance In Surgery Through Integrating Suzetrigine

NCT07257133 | Completed Phase 4 FDA Drug

• 1 other identifier: 25-004867
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

Facial plastic surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain intensity score

  1 day post-operation

Study Arms (1)

Suzetrigine

EXPERIMENTAL

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

Drug: Suzetrigine

Interventions

Suzetrigine 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.

Suzetrigine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Deanna C. Menapace, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: October 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)