Stellate Ganglion Block to Reduce Hot Flushes

Rijnstate Hospital

Status: Completed

Conditions: Hot Flushes; Stellate Ganglion Block; Postmenopausal; Hot Flash

Treatments: Procedure: Bupivacaine block; Procedure: Placebo ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT03756272

NL54465.091.15

Details and patient eligibility

About

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

Full description

Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.

A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation.

Single centre randomized double blind placebo controlled intervention study Study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points.

Study population:

Postmenopausal women aged 30-70 years old with no other causes of flushing present. Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure

Follow up with questionnaires during 6 months.

Enrollment: 76 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age: 30-70 years
• Mean daily flush frequency of 10 or more and a hot flush score of 15 or more
• Absence of any non-menopausal cause of flushing
• Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women
• In case of breast cancer or ovariectomy induced menopause: ovariectomy for > 6 months. Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.

Exclusion criteria

• Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist
• Receiving chemotherapy of radiotherapy
• Active psychiatric disease
• Active concurrent disease
• Allergic reactions against local anesthetics of the 'amide' type or contrast media.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

Stellate ganglion bupivacaine block

Experimental group

Description:

Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion

Treatment:

Procedure: Bupivacaine block

Placebo ganglion block

Placebo Comparator group

Description:

Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)

Treatment:

Procedure: Placebo ganglion block