Stellate Ganglion Block to Reduce Hot Flushes

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.

• Bupivacaine block (Procedure), also known as Stellate ganglion Block: stellate ganglion bupivacaine injection
• Placebo ganglion block (Procedure), also known as stellate ganglion natrium chloride 0.9% injection: stellate ganglion sodium chloride injection

Primary outcomes

• Hot Flush score [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)

Secondary outcomes

• Quality of sleep [Baseline, 4, and 8 weeks]: 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
• Sleepiness [Baseline, 4, and 8 weeks]: 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.

Sex: Female, ages: 30 Years to 70 Years, accepts healthy volunteers

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.

• Jan Willem Kallewaard, MD, Principal investigator, Rijnstate Hospital