Short-term Efficacy of Stellate Ganglion Block to reduce Hot Flushes in wome

Phase 3

Completed

• Conditions: hot flushes; 10021112

• Registration Number: NL-OMON44088
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 76

Inclusion Criteria

female
age 30-70
mean daily flush frequency >9
hot flush score >14
absence of reasons for flushing other than post-menopausal (spontaneous or medical induced)
postmenopausal > 1 year in healthy women (e.g. spontaneous)

Exclusion Criteria

- Use of medication that affects flushing:
estrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlaflaxine, gabapentin, LHRH receptor antagonist
- Still receiving chemotherapy of radiotherapy
- allergy for contrast dye or local anesthetics of amide type
- active concurrent somatic disease
- active concurrent psychiatric disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hot flush score: percentage reduction in hot flush score and the number of<br /><br>subjects reaching a flush score reduction >50%.<br /><br>Hot Flush score = mean daily flush frequency x flush severity<br /><br>(flush severity = mean severity score of every flush on a 1-4 scale) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life, measured with 5 questionnaires:<br /><br>a. Hot Flash-Related Daily Interference Scale (HFRDIS)<br /><br>b. Epworth Sleepiness Scale (ESS)<br /><br>c. PSQI (Pittsburgh Sleep Quality Index)<br /><br>d. MENQOL (Menopause-Specific Quality of Life)<br /><br>e. CES-D (Center for Epidemiologic Studies Depression Scale)</p><br>