Stellate Ganglion Block to Reduce Hot Flushes

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

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

Study Overview

• Status: Completed
• Conditions: Stellate Ganglion Block; Postmenopausal; Hot Flushes; Hot Flash
• Intervention / Treatment: Procedure: Bupivacaine block; Procedure: Placebo ganglion block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stellate ganglion bupivacaine block; Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion	Procedure: Bupivacaine block; stellate ganglion bupivacaine injection; Other Names: Stellate ganglion Block
Placebo Comparator: Placebo ganglion block; Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)	Procedure: Placebo ganglion block; stellate ganglion sodium chloride injection; Other Names: stellate ganglion natrium chloride 0.9% injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): April 28, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Hot Flashes; Ganglion Cysts; Synovial Cyst; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: NL54465.091.15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No