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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992914
• Other study ID #: STU6644
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Procedure:
• Sympathetic nerve block with 1% lidocaine 1-2 ml
Stellate Ganglion Injection
• Superficial subcutaneous injection
Superficial subcutaneous injection with saline

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of hot flushes.		6 months
Secondary	To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.		3 months