Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Flushing

Hot Flashes

Ganglion Cysts

Synovial Cyst

Cysts

Mucinoses

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Bupivacaine

Anesthetics, Local

Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion

Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)

Bupivacaine block

stellate ganglion sodium chloride injection

Placebo ganglion block

Jan Willem Kallewaard, MD

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.

In this study patient and outcome assessor are blinded

Stellate Ganglion Block to Reduce Hot Flushes

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

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)

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stellate Ganglion Block to Reduce Hot Flushes	NCT03756272	Hot Flash Stellate Gangli... Postmenopausal Hot Flushes	Bupivacaine blo... Placebo ganglio...	30 Years - 70 Years	Rijnstate Hospital
Stellate Ganglion Block to Reduce Hot Flushes	NCT03756272	Hot Flash Stellate Gangli... Postmenopausal Hot Flushes	Bupivacaine blo... Placebo ganglio...	30 Years - 70 Years	Rijnstate Hospital
Stellate Ganglion Block to Reduce Hot Flushes	NCT03756272	Hot Flash Stellate Gangli... Postmenopausal Hot Flushes	Bupivacaine blo... Placebo ganglio...	30 Years - 70 Years	Rijnstate Hospital

Spots Global Cancer Trial Database for bupivacaine block