NCT02907983: R01

Stellate Ganglion Blockade in Post-Menopausal Women

Withdrawn Phase 2 Last updated 23 July 2025

What this trial tests

Phase 2 trial testing Stellate Ganglion Block Injection with Bupivicaine in Hot Flashes. Withdrawn.

Timeline

10 July 2018

Primary endpoint
24 August 2023

24 August 2023

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Start date	10 July 2018
Primary completion	24 August 2023
Estimated completion	24 August 2023
Sites	2 locations across United States

Drugs / interventions tested

• Stellate Ganglion Block Injection with Bupivicaine — full drug profile →
• Saline injection

Conditions studied

• Hot Flashes — all drugs for Hot Flashes →
• Hot Flushes — all drugs for Hot Flushes →
• Vasomotor Symptoms — all drugs for Vasomotor Symptoms →

Sponsor

Northwestern University

Who can join

Adults 40 to 70, female only, with Hot Flashes or Hot Flushes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hot flashes and night sweats (vasomotor symptoms, VMS) affect 80% of women during the menopausal transition (MT). VMS are associated with decreased quality of life, increased depressive and anxiety symptoms, memory complaints, sleep disturbance, and reduced work productivity. Hormone therapy (HT) is highly effective in reducing VMS, but the use of HT declined 75% to 80% in the U.S. after the Women's Health Initiative (WHI) raised safety concerns about HT. In 2013, the Food and Drug Administration (FDA) approved paroxetine, a selective serotonin reuptake inhibitor (SSRI; 7.5 mg), as the first non-hormonal treatment for VMS. SSRIs are an important treatment option for many women, but their use in treating VMS is limited by lower effectiveness when compared to HT, side effects, and relapse of symptoms following treatment discontinuation. Identifying safe and effective non-hormonal treatments for VMS remains a priority in women's health research.

Stellate ganglion blockade (SGB), used for decades in pain management, is a potential new approach to VMS treatment. Located in the cervical spine region, the stellate ganglia are part of the sympathetic nervous system. Although SGB is commonly performed to treat neuropathic pain, hyperhidrosis or vascular insufficiency, anatomic studies reveal connections between this ganglion and thermoregulatory regions of the brain, specifically the insular cortex.

In this clinical trial, we aim to assess whether stellate ganglion block (SGB) with bupivacaine, a local anesthetic, is an effective and safe non-hormonal intervention for women seeking relief from vasomotor symptoms (VMS), and identify the physiologic mechanisms underlying SGB effects. Outcomes will include frequency and intensity of hot flashes, objectively-measured VMS, mood, quality of life, sleep, and memory performance in 160 postmenopausal women with 50 or more moderate to very severe hot flashes per week as measured by self-report for six months. They will be reassessed at 3 and 6 months following the SGB or a sham intervention for objective hot flashes and quality of life measures. Mechanistic outcomes (neuroimaging) will be obtained at baseline and 3 months following the intervention. Ambulatory monitoring of sympathetic nervous system function (SKNA) will be performed at baseline before the procedure, during the procedure and 1 hour following the procedure. This will be repeated at 2 and four weeks following the SGB or sham procedure for 1 hour recordings.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.