Overview

This trial is active, not recruiting.

Conditions hot flashes, menopause
Treatments sympathetic nerve block with 1% lidocaine 1-2 ml, superficial subcutaneous injection
Sponsor Northwestern University
Start date February 2009
End date December 2016
Trial size 40 participants
Trial identifier NCT00992914, STU6644

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Active Comparator)
Stellate Ganglion Injection with Lidocaine
sympathetic nerve block with 1% lidocaine 1-2 ml
Stellate Ganglion Injection
(Placebo Comparator)
Superficial subcutaneous injection
superficial subcutaneous injection
Superficial subcutaneous injection with saline

Primary Outcomes

Measure
Reduction of hot flushes.
time frame: 6 months

Secondary Outcomes

Measure
To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
time frame: 3 months

Eligibility Criteria

Female participants from 30 years up to 65 years old.

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.

Additional Information

Official title Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
Principal investigator Lee P Shulman, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Northwestern University.