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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lee Shulman, Northwestern University
ClinicalTrials.gov Identifier:
NCT00992914
First received: October 8, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Hot Flashes
Menopause
 Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml
Procedure: Superficial subcutaneous injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Pilot Study of Stellate Ganglion Injection With Anesthetic as a Method to Provide Relief From Hot Flushes

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Reduction of hot flushes. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the impact of stellate ganglion injection with local anesthetic on cognitive function. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992914

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

No publications provided

Responsible Party: Lee Shulman, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00992914     History of Changes
Other Study ID Numbers: STU6644
Study First Received: October 8, 2009
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ganglion Cysts
Hot Flashes
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013