Opioid Avoidance In Surgery Through Integrating Suzetrigine: Post-Operative Care Phase Pilot
概览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total opioid consumption
概览
简要总结
This prospective, single-arm feasibility study will evaluate postoperative pain control, opioid use, and early recovery outcomes in adult patients undergoing elective outpatient facial plastic surgery who receive suzetrigine as part of their standard postoperative analgesic regimen.
详细描述
Traditional postoperative pain management in facial plastic surgery often relies on opioid analgesics. While effective, their use is associated with adverse effects such as constipation, nausea, vomiting, sedation, respiratory depression, and dependency risk. In the context of the ongoing opioid misuse public health crisis, identifying effective non-opioid alternatives is crucial.
Suzetrigine is a first-in-class oral analgesic that selectively inhibits the voltage-gated sodium channel NaV1.8. These channels are selectively expressed within peripheral pain-sensing neurons and do not have a functional role within the central nervous system (CNS). Unlike opioids, suzetrigine does not cross the blood-brain barrier and avoids CNS side effects such as sedation, respiratory depression, and addiction potential.
In January 2025, the U.S. Food and Drug Administration (FDA) approved suzetrigine for the short-term treatment of moderate-to-severe acute pain in adults. Approval was supported by two Phase 3 randomized controlled trials in patients undergoing abdominoplasty (NCT05558410) and bunionectomy (NCT05553366), both standard models for acute postoperative pain. In these studies, suzetrigine demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen, with a faster onset of meaningful pain relief than placebo and a favorable tolerability profile.
Despite this evidence, there is currently no data on the use of suzetrigine in facial plastic surgery. The integration of suzetrigine into postoperative pain management regimens for this population has the potential to reduce opioid prescription patterns and improve patient outcomes. This single-arm feasibility study aims to describe our early experience with suzetrigine and provide preliminary evidence to inform the feasibility and design of future prospective trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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) undergoing elective outpatient facial plastic surgery.
- •Able to consent and comply with study procedures.
- •Planned postoperative use of suzetrigine per provider discretion.
排除标准
- •Pregnant or breastfeeding.
- •Women on hormonal birth control who decline suzetrigine-related counseling.
- •Patients using strong CYP3A4 inhibitor medications (i.e. itraconazole, ketoconazole, clarithromycin, ritonavir, and grapefruit juice).
- •Known allergy to suzetrigine.
- •Vulnerable or protected research populations.
研究组 & 干预措施
Suzetrigine
Patients will receive Suzetrigine in place of opioid medications for post-operative pain management.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Total opioid consumption
时间窗: 7 days post-operation
Number of opioid pills used during the first 7 postoperative days
Number of patients with no rescue use
时间窗: 7 days post-operation
Total number of patients who do not use any rescue opioids postoperatively
次要结局
- Pain intensity score(1 day post-operation)
研究者
Deanna C. Menapace
Principal Investigator
Mayo Clinic