Hot Flashes, Menopause
Conditions
Keywords
Hot flushes (vasomotor symptoms)
Brief 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. 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.
Interventions
PROCEDURESympathetic nerve block with 1% lidocaine 1-2 ml
Stellate Ganglion Injection
PROCEDURESuperficial subcutaneous injection
Superficial subcutaneous injection with saline
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of hot flushes. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function. | 3 months |
Countries
United States
Outcome results
None listed