A Phase 3 interventional study of Suzetrigine Group in Post-operative Pain, DIEP Flap Breast Reconstruction and DIEP Flap, sponsored by Vanderbilt University Medical Center. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Vanderbilt University Medical Center · Phase 3, Interventional, and Treatment
Among 18 studies testing suzetrigine in Pain, Postoperative — 17 open to participants now, 17 under way, 4 of them phase 3. suzetrigine · Pain, Postoperative.
Among the 18 studies testing suzetrigine in Pain, Postoperative, this one is the 5th largest by planned enrollment, is one of 15 that started in 2026, is one of 4 in phase 3, reaches primary completion later than 8 of the 16 other live ones, and was the 11th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 198 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →17 of the 18 studies testing suzetrigine in Pain, Postoperative are open now, in 1 country. Each count lists the studies.
suzetrigine: first FDA approval 2025 (JOURNAVX). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2025; this study’s year is marked. 15 started in 2026.
Median enrollment 115 across the 18 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
None of the 18 has an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
12 studies in Pain, Postoperative by Vanderbilt University Medical Center: 2 open now, 2 under way, 1 of them phase 3. Of 9 finished, 7 (78%) have results posted.
Among the 12 studies in Pain, Postoperative by Vanderbilt University Medical Center, this one is the 3rd largest by planned enrollment, is one of 2 that started in 2026, is one of 2 in phase 3, and was the 12th registered.
Vanderbilt University Medical Center’s Pain, Postoperative studies by the year they started, since 2007.
9 of the studies testing suzetrigine in Pain, Postoperative that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07539623Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine-enhanced MultimOdal Opioid-sparing THerapy in Cardiac and Bariatric SURGery | 2026-12-22 |
| NCT07548385Phase 3Icahn School of Medicine at Mount SinaiSuzetrigine for Treatment and Reduction of Intense Discomfort After knEe Replacement PAIN | 2027-02-23 |
| NCT07839715Phase 3Vanderbilt University Medical CenterSuzetrigine Post DIEP | 2027-08 |
| NCT07355166University of California, Los AngelesSuzetrigine Versus Usual-care Opioids for Postop Pain in Sports | 2027-01 |
| NCT07821931Stanford UniversitySuzetrigine in Tonsillectomy for Opioid-sparing Pain Management | 2027-06 |
Among the 18 studies testing suzetrigine in Pain, Postoperative, from their registry updates:
Among Vanderbilt University Medical Center’s 12 in Pain, Postoperative:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
ERAS Protocol without Suzetrigine
Patients after DIEP getting both ERAS protocol with suzetrigine
Oral Morphine Equivalent
total oral morphine equivalent amount in mg
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
Renewal of Opioid Prescription
If patient renewed an opioid prescription secondary to pain
Time frame: Evaluated as a binary outcome (Y/N), and quantity of pain medication evaluated at clinic approximately visit 7 days after surgery
No study locations are listed for this record.
Plan to share: Undecided — Pending initial data collection steps
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.
Of 123 non-industry phase 3 interventional studies under Pain, Postoperative, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 11 months is below that.
Counting every sponsor, half of 166 studies reached it within 17 months; a quarter within 8 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Suzetrigine
Vanderbilt University Medical Center →