Health TrialsbyHealthPanel

Suzetrigine Post DIEP

ConditionsPost-operative PainDIEP Flap Breast ReconstructionDIEP FlapOpioidSuzetrigineERAS
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18 years and older

undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)

english speaking

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine Group

    Drug

    Patients after DIEP getting both ERAS protocol with suzetrigine

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Suzetrigine GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: