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

May 8, 2019 updated by: Lee Shulman, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of hot flushes.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Lee P Shulman, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (ESTIMATE)

October 9, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU6644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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