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Completed

NCT Number: NCT00992914

Pilot Study of Stellate Ganglion Injection 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.

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Key information

Conditions

Hot Flashes Menopause Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sympathetic nerve block with 1% lidocaine 1-2 ml

Procedure

Stellate Ganglion Injection

Superficial subcutaneous injection

Procedure

Superficial subcutaneous injection with saline

Primary outcomes

  1. Reduction of hot flushes.

    Time frame: 6 months

Secondary outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2009
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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