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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine injection | Active Comparator | Stellate Ganglion Injection with Lidocaine |
|
| saline injection | Placebo Comparator | Superficial subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sympathetic nerve block with 1% lidocaine 1-2 ml | Procedure | Stellate Ganglion Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of hot flushes. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee P Shulman, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001340 | Autonomic Nerve Block |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Superficial subcutaneous injection | Procedure | Superficial subcutaneous injection with saline |
|
| D003714 |
| Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |