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


N/A
30 Years
65 Years
Open (Enrolling)
Female
Hot Flashes, Menopause

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Outcome Measure:

Reduction of hot flushes.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Lee P Shulman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University

Authority:

United States: Institutional Review Board

Study ID:

STU6644

NCT ID:

NCT00992914

Start Date:

February 2009

Completion Date:

February 2014

Related Keywords:

  • Hot Flashes
  • Menopause
  • Hot flushes (vasomotor symptoms)
  • Ganglion Cysts
  • Hot Flashes

Name

Location

Northwestern UniversityChicago, Illinois  60611