Stellate Ganglion Block to Reduce Hot Flushes
- Conditions
- Stellate Ganglion BlockHot FlashPostmenopausalHot Flushes
- Interventions
- Procedure: Bupivacaine blockProcedure: Placebo ganglion block
- Registration Number
- NCT03756272
- Lead Sponsor
- Rijnstate Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stellate ganglion bupivacaine block Bupivacaine block 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 ganglion block Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Rijnstate hospital
🇳🇱Arnhem, Netherlands