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

NCT00992914 | Completed

• 1 other identifier: STU6644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes; Menopause

Keywords

Hot flushes (vasomotor symptoms)

Outcome Measures

Primary Outcomes (1)

• Reduction of hot flushes.

  6 months

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

Lidocaine injection

ACTIVE COMPARATOR

Stellate Ganglion Injection with Lidocaine

Procedure: Sympathetic nerve block with 1% lidocaine 1-2 ml

saline injection

PLACEBO COMPARATOR

Superficial subcutaneous injection

Procedure: Superficial subcutaneous injection

Interventions

Sympathetic nerve block with 1% lidocaine 1-2 ml PROCEDURE

Stellate Ganglion Injection

Lidocaine injection

Superficial subcutaneous injection PROCEDURE

Superficial subcutaneous injection with saline

saline injection

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women surgically or naturally menopausal,
• Experiencing moderate to severe hot flushes, AND
• Elect to undergo stellate ganglion block procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Autonomic Nerve Block; Lidocaine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Lee P Shulman, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Locations

US (1)