Stellate Ganglion Blockade in Post-Menopausal Women (R01)

This is an interventional supportive care trial for Hot Flashes focused on measuring Menopause, Post-menopausal Read More

Inclusion Criteria:

1. post-menopausal woman defined according to the following criteria: 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels ≥ 40 IU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
2. aged 40 to 70 years
3. 50 or more reported moderate-to-severe hot flashes per week
4. a minimum of two weeks of VMS diary recording prior to SGB
5. post-menopausal women whose vasomotor symptoms are refractory to approved oral treatments (i.e., hormone therapy or paroxetine) or for whom hormone therapy is contraindicated or for women who refuse any oral therapy
6. willingness to undergo fluoroscopy-guided SGB or sham treatment.
7. safety labs within 30 days of SGB intervention

Exclusion Criteria:

1. conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine ; goiter, cardiac/pulmonary compromise; contralateral (left-sided) phrenic nerve paralysis or diaphragmatic paresis; history of seizure, coma, or stroke; history of neurologic deficit to the brachial plexus or an abnormal brachial plexus neurologic exam; history of Zenker's diverticulum; acute illness/infection; coagulopathy or bleeding abnormalities; INR >1.3; hemoglobin<9.0, platelets <100,000, BUN ≥ 30mg/dl; creatinine ≥ 2 mg/ml; ALT (SGPT), AST (SGOT), Alk Phos ≥ three times the upper limit of normal; serum potassium (K+) ≤ 3.5 or ≥ 5.0 mEq/L allergic reactions or contraindications to a local anesthetic or contrast dye, systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg, pregnancy
2. If LMP is between 6 to 12 months, FSH < 40
3. use of treatments less than the washout period and throughout study participation that can affect VMS frequency or severity, including oral (2 months) or transdermal hormone therapy(1 month), botanicals (e.g., soy, red clover, black cohosh, etc.)(1 month), oral contraceptives(2 months), serotonin selective reuptake inhibitors (SSRI) (2 weeks), serotonin norepinephrine reuptake inhibitors (SNRI),( 2 weeks) gabapentin, pregabalin, clonidine, selective estrogen receptor modulators, aromatase inhibitors, tissue selective estrogen complexes;(2months)
4. use of aspirin and non-steroidal anti-inflammatory medications for 3 days prior to the SGB procedure; all other anti-platelet or anticoagulation medications will be discontinued with the permission of the participant's prescribing physician
5. for cognition testing: conditions or disorders that can affect performance on cognitive tests (e.g., dementia/mild cognitive impairment, Mini-Mental State Exam (MMSE) less than or equal to 27) at baseline; stroke; traumatic brain injury; alcohol/substance use; inability to write, speak, or read in English, English as a second language, participation in other studies involving tests of cognitive abilities,
6. conditions that can affect depressive symptoms (e.g., current diagnosis of major depression, bipolar disorder, or other Axis I Psychiatric disorder); Personal Health Questionnaire Depression Scale (PHQ-8)> 15
7. Exclusion criteria for neuroimaging study: implantable pulse generators for pacemakers, defibrillator devices and most but not all spinal cord stimulators or deep brain stimulator, ferrous-containing metals within the body (e.g., braces, aneurysm clips, shrapnel/retained particles) inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), weight > 300 lbs. unless height is sufficiently high [e.g., + 5'11"] so that waist and shoulder circumference do not prevent her from fitting in the scanner; opted out of cognition study, shift work
8. Exclusion criteria for SKNA study only allergic to adhesive in electrode