Stellate Ganglion Block in Women to reduce Hot Flushes

Phase 1

Conditions: Hot Flushes
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-001180-36-NL

Lead Sponsor: Rijnstate Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Female
age 30-70
mean daily flush frequency >9
hot flush score >14
absence of reasons for flushing other than post-menopauzal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Use of medication that affects flushing:
estrogens, progestogens, clonidine, naloxone, paroxetine, fluodxetine, venlaflaxine, gabapentin, LHRH receptor antagonist
-Still receiving chemotherapy of radiotherapy
-Psychiatric disease
-Any unstable concurrent disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the short -term efficacy of stellate ganglion block on hot flush reduction versus sham procedure;Secondary Objective: To assess the eficacy of stellate ganglion block on quality of life;Primary end point(s): Hot flush socre: percentage reduction in hot flush score and the numer of subjects reaching a flush score reduction > 50%<br>Hot Flush score = mean daily flush frequency x flush severity<br>(flush severity = mean severity score of every flush on a 1-4 scale);Timepoint(s) of evaluation of this end point: week 2, week 4, week 8, week 12 and week 26

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Quality of life, measured with 3 questionnaires<br>a. Hot Flash-Related Daily Interference Scale (HFRDIS)<br>b. Epwordth Sleepiness Scale (ESS)<br>c. PSQL (Pittsburgh Sleep Quality Index)<br>d. MENQOL (Menopause-Specific Quality of LIfe)<br>e CES-D (Center for Epidemiologic Studies Depression Scale;Timepoint(s) of evaluation of this end point: week 2, week 4, week 8, week 12 and week 26