Suzetrigine Post DIEP

NCT07839715 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 260703
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is being conducted to see whether adding suzetrigine (Journavx), an FDA-approved non-opioid pain medication, to the standard Enhanced Recovery After Surgery (ERAS) pain management protocol can improve pain after surgery. This is to see if we can decrease the use of opioids, since Journavx works on nerve cells outside of the brain to block pain signals and has no addictive potential. Patients will be provided suzetrigine at a pre-operative clinic visit before you come for surgery so they will have it available during your hospital stay. Oral morphine equivalents will be calculated during the inpatient and outpatient duration to assess if individuals who are assigned to the suzetrigine group have decreased use of opioids compared to the non-suzetrigine patient groups. The hypothesis is that suzetrigine will allow for decreased opioid usage.

Conditions

Post-operative Pain; DIEP Flap Breast Reconstruction; DIEP Flap; Opioid; Suzetrigine; ERAS

Keywords

post-operative pain; DIEP flap reconstruction; autologous breast flap reconstruction; Opioid; suzetrigine; ERAS; ERAS protocol

Outcome Measures

Primary Outcomes (1)

• Oral Morphine Equivalent

  total oral morphine equivalent amount in mg

  Pre-operative baseline pain, immediate post op day 1 and 2 pain, amount of pain medication utilized via medication history. After discharge, one phone call assessing pain and the quantity of pain meds, and at clinic visit 1 week after surgery

Secondary Outcomes (1)

• Renewal of Opioid Prescription

  Evaluated as a binary outcome (Y/N), and quantity of pain medication evaluated at clinic approximately visit 7 days after surgery

Study Arms (2)

Suzetrigine Group

EXPERIMENTAL

Patients assigned after DIEP surgery with ERAS in conjunction with suzetrigine. Dosage of Suzetrigine is as follows: Initial dose: 100 mg orally once Maintenance dose: 50 mg orally every 12 hours, with or without food

Drug: Suzetrigine Group

Control Group

NO INTERVENTION

ERAS Protocol without Suzetrigine

Interventions

Suzetrigine Group DRUG

Patients after DIEP getting both ERAS protocol with suzetrigine

Suzetrigine Group

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 and older
• undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)
• english speaking

You may not qualify if:

• chronic opioid use (daily use greater than 30 days within 90 days preceeding surgery)
• history of substance use disorder
• chronic pain condition requiring daily analgesic therapy
• active infection requiring systemic antibiotics
• significant hepatic impairment
• pregnant women
• prisoners

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

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

• Galen Perdikis, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea C Lin, MD

CONTACT

6154216600; andrea.lin@vumc.org

Sydney Record, MD

CONTACT

6154216598; sydney.record@vumc.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09