Hot FlashNCT03756272
Stellate Ganglion Block to Reduce Hot Flushes
A study testing Bupivacaine block in people with Hot Flash and Stellate Ganglion Block, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flash, Stellate Ganglion Block, Postmenopausal
- What is being tested?
- Bupivacaine block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Hot Flash, Stellate Ganglion Block, Postmenopausal, Hot Flushes
- Being tested
- Bupivacaine block, Placebo ganglion block
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine blockProcedure or surgery
Also called Stellate ganglion Block
stellate ganglion bupivacaine injection
Placebo ganglion blockProcedure or surgery
Also called stellate ganglion natrium chloride 0.9% injection
stellate ganglion sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion bupivacaine block | Experimental | Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion Receives: Procedure: Bupivacaine block |
| Placebo ganglion block | Placebo comparator | Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl) Receives: Procedure: Placebo ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 4, and 8 weeks
Secondary outcomes (2)
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
Measured: 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.
Measured: Baseline, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Sep 2017
- Primary completion28 Apr 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Willem Kallewaard, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756272
- Sponsor's protocol ID
- NL54465.091.15
- Status last verified
- Mar 2020
- First submitted
- 22 Sep 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes
- ClinicalTrials.gov ID
- NCT03756272
- Acronym / sponsor ID
- NL54465.091.15
- Conditions
- Hot Flash, Stellate Ganglion Block, Postmenopausal, Hot Flushes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion bupivacaine block | Experimental | Procedure: Bupivacaine blockNervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion |
| Placebo ganglion block | Placebo comparator | Procedure: Placebo ganglion blockSham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine blockAlso: Stellate ganglion Blockstellate ganglion bupivacaine injection | Procedure or surgery | Stellate ganglion bupivacaine block |
| Placebo ganglion blockAlso: stellate ganglion natrium chloride 0.9% injectionstellate ganglion sodium chloride injection | Procedure or surgery | Placebo ganglion block |
Primary outcome
Hot Flush score
Time frame: Baseline, 4, and 8 weeks
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)
2 secondary outcomes
Quality of sleep
Time frame: Baseline, 4, and 8 weeks
Sleepiness
Time frame: Baseline, 4, and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Willem Kallewaard, MD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine block in people with Hot Flash and Stellate Ganglion Block, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hot Flush score (time frame: Baseline, 4, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.