<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756272</url>
  </required_header>
  <id_info>
    <org_study_id>NL54465.091.15</org_study_id>
    <nct_id>NCT03756272</nct_id>
  </id_info>
  <brief_title>Stellate Ganglion Block to Reduce Hot Flushes</brief_title>
  <official_title>Short-term Efficacy of Stellate Ganglion Block to Reduce Hot Flushes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rijnstate Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus&#xD;
      sham procedure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hot flushes are the most common symptom of menopause for which postmenopausal (PMP) women&#xD;
      seek medical help, in 20% of PMP women hot flushes can persist for up to 15 years.&#xD;
&#xD;
      A possible treatment for hot flushes is stellate ganglion block (SGB), used as a means to&#xD;
      interrupt parts of the sympathetic nervous system involved in temperature regulation.&#xD;
&#xD;
      Single centre randomized double blind placebo controlled intervention study Study period of 6&#xD;
      months in which patients will fill out on set time points 5 questionnaires regarding quality&#xD;
      of life and keep a diary on hot flush frequency and severity during1 week on the same time&#xD;
      points.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Postmenopausal women aged 30-70 years old with no other causes of flushing present.&#xD;
      Intervention (if applicable) Intervention: Stellate ganglion block versus sham procedure&#xD;
&#xD;
      Follow up with questionnaires during 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>In this study patient and outcome assessor are blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Hot Flush score</measure>
    <time_frame>Baseline, 4, and 8 weeks</time_frame>
    <description>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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>Baseline, 4, and 8 weeks</time_frame>
    <description>Pittsburgh Sleep Quality Index: developed to discriminate between good and poor sleep quality. It consists of 19 individual items, creating seven components of sleep (sleep onset latency, sleep duration, sleep efficiency, sleep quality, sleep disturbances,medication, and day-time dysfunction). Each of those seven components is scored from 0 to 3. The sum of the individual scores forms the global score (0-21) of the PSQI. Lower global scores denote high sleep quality, whereas a score greater than 5 is considered poor sleep quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>Baseline, 4, and 8 weeks</time_frame>
    <description>Epworth Sleepiness Scale. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The reference range of 'normal' ESS scores is zero to 10.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Hot Flash</condition>
  <condition>Stellate Ganglion Block</condition>
  <condition>Postmenopausal</condition>
  <condition>Hot Flushes</condition>
  <arm_group>
    <arm_group_label>Stellate ganglion bupivacaine block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo ganglion block</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bupivacaine block</intervention_name>
    <description>stellate ganglion bupivacaine injection</description>
    <arm_group_label>Stellate ganglion bupivacaine block</arm_group_label>
    <other_name>Stellate ganglion Block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo ganglion block</intervention_name>
    <description>stellate ganglion sodium chloride injection</description>
    <arm_group_label>Placebo ganglion block</arm_group_label>
    <other_name>stellate ganglion natrium chloride 0.9% injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age: 30-70 years&#xD;
&#xD;
          -  Mean daily flush frequency of 10 or more and a hot flush score of 15 or more&#xD;
&#xD;
          -  Absence of any non-menopausal cause of flushing&#xD;
&#xD;
          -  Post-menopause amenorrhea for more than 1 year in healthy postmenopausal women&#xD;
&#xD;
          -  In case of breast cancer or ovariectomy induced menopause: ovariectomy for &gt; 6 months.&#xD;
             Adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone,&#xD;
             paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing&#xD;
             hormones receptor antagonist&#xD;
&#xD;
          -  Receiving chemotherapy of radiotherapy&#xD;
&#xD;
          -  Active psychiatric disease&#xD;
&#xD;
          -  Active concurrent disease&#xD;
&#xD;
          -  Allergic reactions against local anesthetics of the 'amide' type or contrast media.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Willem Kallewaard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rijnstate Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate hospital</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganglion Cysts</mesh_term>
    <mesh_term>Synovial Cyst</mesh_term>
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756272
org study id: NL54465.091.15
nct id: NCT03756272
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus
      sham procedure
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: In this study patient and outcome assessor are blinded
measure: Hot Flush score
time frame: Baseline, 4, and 8 weeks
description: 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)
measure: Quality of sleep
time frame: Baseline, 4, and 8 weeks
description: Pittsburgh Sleep Quality Index: developed to discriminate between good and poor sleep quality. It consists of 19 individual items, creating seven components of sleep (sleep onset latency, sleep duration, sleep efficiency, sleep quality, sleep disturbances,medication, and day-time dysfunction). Each of those seven components is scored from 0 to 3. The sum of the individual scores forms the global score (0-21) of the PSQI. Lower global scores denote high sleep quality, whereas a score greater than 5 is considered poor sleep quality
measure: Sleepiness
time frame: Baseline, 4, and 8 weeks
description: Epworth Sleepiness Scale. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The reference range of 'normal' ESS scores is zero to 10.
arm group label: Stellate ganglion bupivacaine block
arm group type: Experimental
description: Nervus Sympathicus block. Stellate ganglion anaesthetic block in which 7 ml of 0.5% bupivacaine will be injected next to the stellate ganglion
arm group label: Placebo ganglion block
arm group type: Placebo Comparator
description: Sham Nervus Sympathicus block. Stellate ganglion sham anaesthetic block using 7 ml of 0.9 % natrium chloride (NaCl)
intervention type: Procedure
intervention name: Bupivacaine block
description: stellate ganglion bupivacaine injection
arm group label: Stellate ganglion bupivacaine block
other name: Stellate ganglion Block
intervention type: Procedure
intervention name: Placebo ganglion block
description: stellate ganglion sodium chloride injection
arm group label: Placebo ganglion block
other name: stellate ganglion natrium chloride 0.9% injection
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Willem Kallewaard, MD
role: Principal Investigator
affiliation: Rijnstate Hospital
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Ganglion Cysts
mesh term: Synovial Cyst
mesh term: Hot Flashes
mesh term: Bupivacaine