Stellate Ganglion Block in Women to reduce Hot Flushes

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001180-36-NL

Enrollment

130

Registered

2016-10-19

Start date

2016-12-01

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flushes

Interventions

Trade Name: Bupivacaïne Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacaïne Current Sponsor code: bupi Other descriptive name: BUPIVACAINEHYDROCHLORIDE ANHYDRAAT Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: week 2, week 4, week 8, week 12 and week 26;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% Hot Flush score = mean daily flush frequency x flush severity (flush severity = mean severity score of every flush on a 1-4 scale)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: week 2, week 4, week 8, week 12 and week 26;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% Hot Flush score = mean daily flush frequency x flush severity (flush severity = mean severity score of every flush on a 1-4 scale)

—

Secondary

Measure	Time frame
Secondary end point(s): Quality of life, measured with 3 questionnaires a. Hot Flash-Related Daily Interference Scale (HFRDIS) b. Epwordth Sleepiness Scale (ESS) c. PSQL (Pittsburgh Sleep Quality Index) d. MENQOL (Menopause-Specific Quality of LIfe) 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	—

Countries

Netherlands

Contacts

Public ContactPrincipal investigator

Rijnstate Hospital

jkallewaard@rijnstate.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026