Stellate Ganglion Block to Reduce Hot Flushes

NCT03756272 | Completed DMC

• 1 other identifier: NL54465.091.15
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hot Flash; Stellate Ganglion Block; Postmenopausal; Hot Flushes

Outcome Measures

Primary Outcomes (1)

• Hot Flush score

  Hot flush score as measured by a hot flush diary in which for each hot flush the severity is noted for one week. Severity of every flush is given on a 1-4 scale (1 is mild, 2 medium, 3 severe, and 4 is very severe)

  Baseline, 4, and 8 weeks

Secondary Outcomes (2)

• Quality of sleep

  Baseline, 4, and 8 weeks

• Sleepiness

  Baseline, 4, and 8 weeks

Study Arms (2)

Stellate ganglion bupivacaine block

EXPERIMENTAL

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

Procedure: Bupivacaine block

Placebo ganglion block

PLACEBO COMPARATOR

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

Procedure: Placebo ganglion block

Interventions

Bupivacaine block PROCEDURE

stellate ganglion bupivacaine injection

Also known as: Stellate ganglion Block

Stellate ganglion bupivacaine block

Placebo ganglion block PROCEDURE

stellate ganglion sodium chloride injection

Also known as: stellate ganglion natrium chloride 0.9% injection

Placebo ganglion block

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate hospital

Arnhem, Netherlands

Location

MeSH Terms

Conditions

Hot Flashes

Interventions

Injections

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jan Willem Kallewaard, MD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this study patient and outcome assessor are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: November 28, 2018
• Study Start: September 1, 2017
• Primary Completion: April 28, 2018
• Study Completion: February 1, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

NL (1)