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Stellate Ganglion Block to Reduce Hot Flushes

Primary Purpose

Hot Flash, Stellate Ganglion Block, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Bupivacaine block
Placebo ganglion block
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flash

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Rijnstate hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Stellate ganglion bupivacaine block

Placebo ganglion block

Arm Description

Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion

Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.

Full Information

First Posted
September 22, 2017
Last Updated
March 10, 2020
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03756272
Brief Title
Stellate Ganglion Block to Reduce Hot Flushes
Official Title
Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flash, Stellate Ganglion Block, Postmenopausal, Hot Flushes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
In this study patient and outcome assessor are blinded
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stellate ganglion bupivacaine block
Arm Type
Experimental
Arm Description
Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion
Arm Title
Placebo ganglion block
Arm Type
Placebo Comparator
Arm Description
Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)
Intervention Type
Procedure
Intervention Name(s)
Bupivacaine block
Other Intervention Name(s)
Stellate ganglion Block
Intervention Description
stellate ganglion bupivacaine injection
Intervention Type
Procedure
Intervention Name(s)
Placebo ganglion block
Other Intervention Name(s)
stellate ganglion natrium chloride 0.9% injection
Intervention Description
stellate ganglion sodium chloride injection
Primary Outcome Measure Information:
Title
Hot Flush score
Description
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)
Time Frame
Baseline, 4, and 8 weeks
Secondary Outcome Measure Information:
Title
Quality of sleep
Description
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
Time Frame
Baseline, 4, and 8 weeks
Title
Sleepiness
Description
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.
Time Frame
Baseline, 4, and 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Willem Kallewaard, MD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands

12. IPD Sharing Statement

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Stellate Ganglion Block to Reduce Hot Flushes

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