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NCT Number: NCT07839715

Suzetrigine Post DIEP

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.

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Key information

Conditions

Post-operative Pain DIEP Flap DIEP Flap Breast Reconstruction ERAS Neurologic Manifestations Opioid Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Suzetrigine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

The current Enhanced Recovery After Surgery (ERAS) protocol for deep inferior epigastric perforator (DIEP) flap breast reconstruction has consistently shown significant reduction in patient post-operative pain and oral morphine milligram equivalents (MME). Currently the protocol incorporates opioids as an analgesic for breakthrough pain, which is usually needed, but the protocol has decreased MME to 90-115 from 275+ with standard care. Though patient opioid consumption has decreased with ERAS protocol compliance, completely opioid free recovery remains uncommon for this procedure. Therefore, additional opioid-sparing methods are of interest to further optimize post-operative pain in these patients. Suzetrigine (journavx) is a non-opioid oral analgesic approved by the FDA in 2025 for treatment of moderate to severe acute pain, making it the first approved drug in its class. It has been used to manage moderate to severe acute pain in adults and works by selectively blocking the NaV1.8 voltage-gated sodium channel. Despite the reduction in patient reported pain and MME after DIEP flap reconstruction with the adoption of ERAS protocols, opioid use for breakthrough pain remains common. The addition of a non-opioid adjunct may further reduce opioid exposure without compromising pain control. This study will evaluate whether the incorporation of Suzetrigine into the post-operative analgesic regimen improves pain management and reduces opioid requirements in patients undergoing DIEP flap reconstruction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18 years and older
  • undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)
  • english speaking

Exclusion criteria

  • 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

Treatment and study plan

Suzetrigine Group

Drug

Patients after DIEP getting both ERAS protocol with suzetrigine

Primary outcomes

  1. Oral Morphine Equivalent

    Time frame: 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

    total oral morphine equivalent amount in mg

Secondary outcomes

  1. Renewal of Opioid Prescription

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

    If patient renewed an opioid prescription secondary to pain

Interested in participating?

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Trial opening soon.

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Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Evaluation of Suzetrigine Within an ERAS Protocol for DIEP Flap Breast Reconstruction: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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