Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes

Conditions
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Hot Flashes, Menopause

Intervention / Treatment
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* Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml
* Procedure: Superficial subcutaneous injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women surgically or naturally menopausal, Experiencing moderate to severe hot flushes, AND Elect to undergo stellate ganglion block procedure. Exclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine injection<br>Stellate Ganglion Injection with Lidocaine | Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml<br>* Stellate Ganglion Injection<br>|
| Placebo Comparator: saline injection<br>Superficial subcutaneous injection | Procedure: Superficial subcutaneous injection<br>* Superficial subcutaneous injection with saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hot flushes. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function. |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flushes (vasomotor symptoms)