Post-operative PainPhase 3NCT07839715
Suzetrigine Post DIEP
A Phase 3 study testing Suzetrigine Group in people with Post-operative Pain and DIEP Flap Breast Reconstruction, run by Vanderbilt University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain, DIEP Flap Breast Reconstruction, DIEP Flap
- What is being tested?
- Suzetrigine Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)
- english speaking
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Suzetrigine Within an ERAS Protocol for DIEP Flap Breast Reconstruction: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Post-operative Pain, DIEP Flap Breast Reconstruction, DIEP Flap, Opioid, Suzetrigine, ERAS
- Being tested
- Suzetrigine Group
- Keywords
- post-operative pain, DIEP flap reconstruction, autologous breast flap reconstruction, Opioid, suzetrigine, ERAS, ERAS protocol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzetrigine GroupDrug
Patients after DIEP getting both ERAS protocol with suzetrigine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Suzetrigine Group |
| Control Group | No intervention | ERAS Protocol without Suzetrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Morphine Equivalent
total oral morphine equivalent amount in mg
Measured: 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
If patient renewed an opioid prescription secondary to pain
Measured: Evaluated as a binary outcome (Y/N), and quantity of pain medication evaluated at clinic approximately visit 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galen Perdikis, Vanderbilt University Medical Center
- Investigators
- Galen Perdikis, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839715
- Sponsor's protocol ID
- 260703
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pending initial data collection steps
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Suzetrigine Within an ERAS Protocol for DIEP Flap Breast Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07839715
- Acronym / sponsor ID
- 260703
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzetrigine Group | Experimental | Drug: Suzetrigine GroupPatients 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 |
| Control Group | No intervention | –ERAS Protocol without Suzetrigine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years and older
- undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)
- english speaking
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suzetrigine GroupPatients after DIEP getting both ERAS protocol with suzetrigine | Drug | Suzetrigine Group |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided. Pending initial data collection steps
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Galen Perdikis, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Suzetrigine Group in people with Post-operative Pain and DIEP Flap Breast Reconstruction, run by Vanderbilt University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea C Lin, MD (6154216600, andrea.lin@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.