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To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate ganglion bupivacaine block | Experimental | Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion |
|
| Placebo ganglion block | Placebo Comparator | Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine block | Procedure | stellate ganglion bupivacaine injection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Willem Kallewaard, MD | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate hospital | Arnhem | Netherlands |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Randomized controlled trial
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In this study patient and outcome assessor are blinded
| Placebo ganglion block | Procedure | stellate ganglion sodium chloride injection |
|
|
| 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 |