Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Hot Flush score
研究概览
简要总结
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
详细描述
Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.
A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation.
Single centre randomized double blind placebo controlled intervention study Study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points.
Study population:
Postmenopausal women aged 30-70 years old with no other causes of flushing present. Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure
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
- Double (Participant, Outcomes Assessor)
盲法说明
In this study patient and outcome assessor are blinded
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 30-70 years
- •Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
- •Absence of any non-menopausal cause of flushing
- •Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
- •In case of breast cancer or ovariectomy induced menopause: ovariectomy for > 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.
排除标准
- •Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
- •Receiving chemotherapy of radiotherapy
- •Active psychiatric disease
- •Active concurrent disease
- •Allergic reactions against local anesthetics of the 'amide' type or contrast media.
结局指标
主要结局
Hot Flush score
时间窗: Baseline, 4, and 8 weeks
Hot flush score as measured by a hot flush diary in which for each hot flush the severity is noted for one week. Severity of every flush is given on a 1-4 scale (1 is mild, 2 medium, 3 severe, and 4 is very severe)
次要结局
- Quality of sleep(Baseline, 4, and 8 weeks)
- Sleepiness(Baseline, 4, and 8 weeks)