search
Back to results

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

Primary Purpose

Hot Flashes, Menopause

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sympathetic nerve block with 1% lidocaine 1-2 ml
Superficial subcutaneous injection
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Hot flushes (vasomotor symptoms)

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine injection

saline injection

Arm Description

Stellate Ganglion Injection with Lidocaine

Superficial subcutaneous injection

Outcomes

Primary Outcome Measures

Reduction of hot flushes.

Secondary Outcome Measures

To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.

Full Information

First Posted
October 8, 2009
Last Updated
May 8, 2019
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT00992914
Brief Title
Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes
Official Title
Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Menopause
Keywords
Hot flushes (vasomotor symptoms)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine injection
Arm Type
Active Comparator
Arm Description
Stellate Ganglion Injection with Lidocaine
Arm Title
saline injection
Arm Type
Placebo Comparator
Arm Description
Superficial subcutaneous injection
Intervention Type
Procedure
Intervention Name(s)
Sympathetic nerve block with 1% lidocaine 1-2 ml
Intervention Description
Stellate Ganglion Injection
Intervention Type
Procedure
Intervention Name(s)
Superficial subcutaneous injection
Intervention Description
Superficial subcutaneous injection with saline
Primary Outcome Measure Information:
Title
Reduction of hot flushes.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee P Shulman, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs