Hot FlashesNCT00992914
Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes
A study testing Sympathetic nerve block with 1% lidocaine 1-2 ml and Superficial subcutaneous injection in people with Hot Flashes and Menopause, run by Northwestern University at 1 site in United States.
Trial summary
This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- Sympathetic nerve block with 1% lidocaine 1-2 ml and Superficial subcutaneous injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2018
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women surgically or naturally menopausal,
- Experiencing moderate to severe hot flushes, AND
- Elect to undergo stellate ganglion block procedure.
Who cannot join
- Subjects who are currently sick,
- Subjects have acute infections or cardiac compromise,
- Subjects who have local infections of the anterior neck region, severe
- Subjects who have pulmonary disease,
- Subjects who are anticoagulated,
- Subjects who are on hormone therapy,
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- Subjects who have a blood clotting disorder,
- Subjects who have an American Society of Anesthesiologists (ASA) physical status score of 3 or higher (severe systemic disease, not incapacitating),
- Subjects who have allergic reactions to local anesthetics and/or contrast dyes,
- Subjects who have past or present diagnosis of psychosis,
- Subjects who have current diagnosis of depression, OR
- Subjects who have current substance or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes.
Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. Hot flashes are the most common reason that women seek hormonal therapy. However, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes.
The study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. The study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.
- Conditions
- Hot Flashes, Menopause
- Being tested
- Sympathetic nerve block with 1% lidocaine 1-2 ml, Superficial subcutaneous injection
- Keywords
- Hot flushes (vasomotor symptoms)
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathetic nerve block with 1% lidocaine 1-2 mlProcedure or surgery
Stellate Ganglion Injection
Superficial subcutaneous injectionProcedure or surgery
Superficial subcutaneous injection with saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine injection | Active comparator | Stellate Ganglion Injection with Lidocaine Receives: Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml |
| saline injection | Placebo comparator | Superficial subcutaneous injection Receives: Procedure: Superficial subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of hot flushes.
Measured: 6 months
Secondary outcomes (1)
To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Shulman, Northwestern University
- Investigators
- Lee P Shulman, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992914
- Sponsor's protocol ID
- STU6644
- Status last verified
- May 2019
- First submitted
- 8 Oct 2009
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
- ClinicalTrials.gov ID
- NCT00992914
- Acronym / sponsor ID
- STU6644
- Conditions
- Hot Flashes, Menopause
- Keywords
- Hot flushes (vasomotor symptoms)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 9 Oct 2009 (estimated)
- 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.
This study is being done to determine whether stellate ganglion injection with local anesthetic (the study procedure) can reduce the number and severity of hot flashes in women who have hot flashes.
Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue and irritability during the day. Hot flashes are the most common reason that women seek hormonal therapy. However, for many women, including breast cancer survivors, this is rarely an option, and these women seek alternatives to hormonal therapy to treat hot flashes.
The study procedure has been in clinical use for more than fifty years in treating certain disease states and chronic pain. The study procedure has not been used to relieve hot flashes and the use of the study procedure with local anesthetic for the reduction of hot flushes is considered experimental.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine injection | Active comparator | Procedure: Sympathetic nerve block with 1% lidocaine 1-2 mlStellate Ganglion Injection with Lidocaine |
| saline injection | Placebo comparator | Procedure: Superficial subcutaneous injectionSuperficial subcutaneous injection |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women surgically or naturally menopausal,
- Experiencing moderate to severe hot flushes, AND
- Elect to undergo stellate ganglion block procedure.
Key exclusion criteria (12 listed)
- Subjects who are currently sick,
- Subjects have acute infections or cardiac compromise,
- Subjects who have local infections of the anterior neck region, severe
- Subjects who have pulmonary disease,
- Subjects who are anticoagulated,
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 |
|---|---|---|
| Sympathetic nerve block with 1% lidocaine 1-2 mlStellate Ganglion Injection | Procedure or surgery | Lidocaine injection |
| Superficial subcutaneous injectionSuperficial subcutaneous injection with saline | Procedure or surgery | saline injection |
Primary outcome
Reduction of hot flushes.
Time frame: 6 months
1 secondary outcome
To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
Time frame: 3 months
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 10 May 2019.
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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.
Lee P Shulman, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sympathetic nerve block with 1% lidocaine 1-2 ml and Superficial subcutaneous injection in people with Hot Flashes and Menopause, run by Northwestern University at 1 site in United States.
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 3 inclusion and 12 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 10 May 2019. 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 United States. 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?
Reduction of hot flushes. (time frame: 6 months). 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 10 May 2019.