Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction of hot flushes.
研究概览
简要总结
This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes.
Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. Hot flashes are the most common reason that women seek hormonal therapy. However, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes.
The study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. The study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women surgically or naturally menopausal,
- •Experiencing moderate to severe hot flushes, AND
- •Elect to undergo stellate ganglion block procedure.
排除标准
- •Subjects who are currently sick,
- •Subjects have acute infections or cardiac compromise,
- •Subjects who have local infections of the anterior neck region, severe
- •Subjects who have pulmonary disease,
- •Subjects who are anticoagulated,
- •Subjects who are on hormone therapy,
- •Subjects who have a blood clotting disorder,
- •Subjects who have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating),
- •Subjects who have allergic reactions to local anesthetics and/or contrast dyes,
- •Subjects who have past or present diagnosis of psychosis,
- •Subjects who have current diagnosis of depression, OR
- •Subjects who have current substance or alcohol abuse.
研究组 & 干预措施
Lidocaine injection
Stellate Ganglion Injection with Lidocaine
干预措施: Sympathetic nerve block with 1% lidocaine 1-2 ml (Procedure)
saline injection
Superficial subcutaneous injection
干预措施: Superficial subcutaneous injection (Procedure)
结局指标
主要结局
Reduction of hot flushes.
时间窗: 6 months
次要结局
- To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.(3 months)
研究者
Lee Shulman
Professor
Northwestern University