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Stellate Ganglion Nerve Block in Treating Women With Hot Flashes

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic Identifier:
First received: April 8, 2009
Last updated: October 15, 2014
Last verified: October 2014

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.

Condition Intervention Phase
Hot Flashes
Drug: bupivacaine hydrochloride
Other: questionnaire administration
Early Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: Pilot Evaluation of a Stellate Ganglion Block for the Treatment of Hot Flashes

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Difference in hot flash activity between baseline and week 7

Secondary Outcome Measures:
  • Difference in quality of life, toxicity, and self-assessment items between baseline and week 7

Estimated Enrollment: 10
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Presence of hot flashes for ≥ 1 month prior to study registration

    • Hot flashes considered bothersome (defined by their occurrence of ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention)
  • Use of more conventional hot flash treatments (including newer antidepressants and gabapentin) have failed to control hot flashes (as defined by the patient)


  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • Not of childbearing potential, as judged by the attending clinician
  • Able to complete questionnaires alone or with assistance
  • No evidence of an active malignancy
  • No von Willebrand's disease or other bleeding disorders
  • No allergy to chlorhexidine or bupivacaine


  • More than 4 weeks since prior and no concurrent antineoplastic chemotherapy, androgens, estrogens, or progestational agents

    • Tamoxifen, raloxifene, or aromatase inhibitors allowed provided the patient has been on a constant dose for ≥ 4 weeks and continues to receive medication during study treatment
  • More than 10 days since prior and no concurrent anticoagulants (e.g., aspirin, clopidogrel, ticlopidine, or warfarin)

    • Concurrent heparin flushes for venous catheter allowed
  • No concurrent use of other agents (e.g., megestrol acetate, soy, clonidine, or Bellergal) for treating hot flashes

    • Vitamin E, gabapentin, or antidepressants allowed provided the patient has been on a stable dose for > 30 days and continues to receive medication during study treatment
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Please refer to this study by its identifier: NCT00879164

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mayo Clinic Identifier: NCT00879164     History of Changes
Other Study ID Numbers: CDR0000640197
P30CA015083 ( US NIH Grant/Contract Award Number )
MC08C8 ( Other Identifier: Mayo Clinic Cancer Center )
08-006796 ( Other Identifier: Mayo Clinic IRB )
NCI-2009-01133 ( Other Identifier: NCI-CTRP )
Study First Received: April 8, 2009
Last Updated: October 15, 2014

Keywords provided by Mayo Clinic:
hot flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 24, 2017