Stellate Ganglion Blockade in Post-Menopausal Women
Status:
Recruiting
Trial end date:
2022-08-31
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
David Walega
Collaborators:
Indiana University University of Illinois at Chicago