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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
198
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
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