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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992914
Recruitment Status : Active, not recruiting
First Posted : October 9, 2009
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Lee Shulman, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hot Flashes Menopause Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml Procedure: Superficial subcutaneous injection Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
Study Start Date : February 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lidocaine injection
Stellate Ganglion Injection with Lidocaine
Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml
Stellate Ganglion Injection
Placebo Comparator: saline injection
Superficial subcutaneous injection
Procedure: Superficial subcutaneous injection
Superficial subcutaneous injection with saline

Primary Outcome Measures :
  1. Reduction of hot flushes. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992914

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Lee P Shulman, MD Northwestern University

Responsible Party: Lee Shulman, Professor, Northwestern University Identifier: NCT00992914     History of Changes
Other Study ID Numbers: STU6644
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Lee Shulman, Northwestern University:
Hot flushes (vasomotor symptoms)

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action