Stellate Ganglion Block to Reduce Hot Flushes

Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756272
• Other study ID #: NL54465.091.15
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2020
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

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 information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 1, 2019
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Hot Flash
• Hot Flashes
• Hot Flushes
• Postmenopausal
• Stellate Ganglion Block

Intervention

Procedure:
• Bupivacaine block
stellate ganglion bupivacaine injection
• Placebo ganglion block
stellate ganglion sodium chloride injection

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	Baseline, 4, and 8 weeks
Secondary	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