Clinical Trial: Stellate Ganglion Nerve Block in Treating Women With Hot Flashes
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes
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 Summary:
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.
Sponsor: Mayo Clinic
Current Primary Outcome: Difference in hot flash activity between baseline and week 7
Original Primary Outcome: Same as current
Current Secondary Outcome: Difference in quality of life, toxicity, and self-assessment items between baseline and week 7
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: April 8, 2009
Date Started: April 2009
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014
