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NCT07839715
Suzetrigine Post DIEP
Conditions: Post-operative Pain, DIEP Flap Breast Reconstruction, DIEP Flap, Opioid, Suzetrigine, ERAS
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 198
Sponsor: Vanderbilt University Medical Center
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07839715). StuddyBuddy aggregates publicly available trial information.