Stellate Ganglion Block to Reduce Hot Flushes

Study Overview
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Brief Summary
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To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Detailed Description
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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 Follow up with questionnaires during 6 months.

Official Title
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Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes

Conditions
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Hot Flash, Stellate Ganglion Block, Postmenopausal, Hot Flushes

Intervention / Treatment
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* Procedure: Bupivacaine block
* Procedure: Placebo ganglion block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate ganglion bupivacaine block<br>Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion | Procedure: Bupivacaine block<br>* stellate ganglion bupivacaine injection<br>* Other names: Stellate ganglion Block;|
| Placebo Comparator: Placebo ganglion block<br>Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl) | Procedure: Placebo ganglion block<br>* stellate ganglion sodium chloride injection<br>* Other names: stellate ganglion natrium chloride 0.9% injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot Flush score | 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) | Baseline, 4, and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of sleep | Pittsburgh Sleep Quality Index: developed to discriminate between good and poor sleep quality. It consists of 19 individual items, creating seven components of sleep (sleep onset latency, sleep duration, sleep efficiency, sleep quality, sleep disturbances,medication, and day-time dysfunction). Each of those seven components is scored from 0 to 3. The sum of the individual scores forms the global score (0-21) of the PSQI. Lower global scores denote high sleep quality, whereas a score greater than 5 is considered poor sleep quality | Baseline, 4, and 8 weeks | 
| Sleepiness | Epworth Sleepiness Scale. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The reference range of 'normal' ESS scores is zero to 10. | Baseline, 4, and 8 weeks |