Skip to main content
OpenTrials
Completed

NCT Number: NCT03756272

Stellate Ganglion Block to Reduce Hot Flushes

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hot Flash Hot Flashes Hot Flushes Pathological Conditions, Signs and Symptoms Postmenopausal Signs and Symptoms Stellate Ganglion Block

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate hospital

Arnhem, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine block

Procedure

stellate ganglion bupivacaine injection

Other names: Stellate ganglion Block

Placebo ganglion block

Procedure

stellate ganglion sodium chloride injection

Other names: stellate ganglion natrium chloride 0.9% injection

Primary outcomes

  1. Hot Flush score

    Time frame: 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

  1. Quality of sleep

    Time frame: 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

  2. Sleepiness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.