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临床试验/NCT07839715
NCT07839715尚未招募3 期

Evaluation of Suzetrigine Within an ERAS Protocol for DIEP Flap Breast Reconstruction: A Randomized Controlled Trial

Vanderbilt University Medical Center0 个研究点目标入组 198 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
198
主要终点
Oral Morphine Equivalent

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults 18 years and older
  • •undergoing elective autologous breast reconstruction with deep inferior epigastric (DIEP)flap (unilateral or bilateral)
  • •english speaking

排除标准

  • •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

研究组 & 干预措施

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

干预措施: Suzetrigine Group (Drug)

Control Group

No Intervention

ERAS Protocol without Suzetrigine

结局指标

主要结局

Oral Morphine Equivalent

时间窗: 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

次要结局

  • Renewal of Opioid Prescription(Evaluated as a binary outcome (Y/N), and quantity of pain medication evaluated at clinic approximately visit 7 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Galen Perdikis

Principal Investigator

Vanderbilt University Medical Center

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