Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

Early Phase 1

Completed

• Conditions: Hot Flashes

• Registration Number: NCT00879164
• Lead Sponsor: Mayo Clinic

Brief Summary

RATIONALE: A stellate ganglion nerve block may help relieve hot flashes in women.

PURPOSE: This clinical trial is studying how well a stellate ganglion nerve block works in treating women with hot flashes.

Detailed Description

OBJECTIVES:

* To evaluate the impact of stellate ganglion blockade on hot flash scores.

* To evaluate the toxicity of stellate ganglion blockade.

OUTLINE: Patients undergo fluoroscopic-guided stellate ganglion blockade using bupivacaine hydrochloride in week 1.

Patients complete a hot flash diary daily and a symptom experience diary weekly in weeks 1-7 and the Profile of Mood States questionnaire in weeks 1 and 7.

After completion of study treatment, patients are followed at 2 months and then monthly for 1 year.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in hot flash activity between baseline and week 7

Secondary Outcome Measures

Name	Time	Method
Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States