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临床试验/NCT07257133
NCT07257133
已完成
4 期

Opioid Avoidance In Surgery Through Integrating Suzetrigine: Post-Operative Care Phase Pilot

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月20日最近更新:
干预措施Suzetrigine
相关药物Suzetrigine

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

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

Experimental

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deanna C. Menapace

Principal Investigator

Mayo Clinic

研究点 (2)

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