Hot Flash, Hot Flushes, Postmenopausal, Stellate Ganglion Block
Conditions
Brief summary
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
Detailed description
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.
Interventions
PROCEDUREBupivacaine block
stellate ganglion bupivacaine injection
PROCEDUREPlacebo ganglion block
stellate ganglion sodium chloride injection
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
In this study patient and outcome assessor are blinded
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed