<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/NCT04439760</url>
  </required_header>
  <id_info>
    <org_study_id>transcranial Doppler</org_study_id>
    <nct_id>NCT04439760</nct_id>
  </id_info>
  <brief_title>Superior Cervical Ganglion Block, Transcranial Doppler</brief_title>
  <official_title>Efficacy of Superior Cervical Ganglion (SCG) Block on the Incidence and Severity of Vasospasm After Middle Cerebral Artery (MCA)Aneurysmal Surgery Using Transcranial Doppler(TCD). A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatma Ibrahim El Sayed Salman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess blood flow velocity in middle cerebral artery measured by&#xD;
      transcranial doppler to determine the efficacy of SCG block in decreasing incidence or&#xD;
      severity of vasospasm after MCA aneurysm surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sympathetic innervation to the face and head is by superior cervical ganglion(SCG), which is&#xD;
      the most cranial part of the sympathetic chain. It is suited in a plication of the&#xD;
      prevertebral fascia anterior to the longuscapitis muscle and dorsal to the internal carotid&#xD;
      artery, posteromedial to the vagus nerve at c3 level. It's mainly located at the level of the&#xD;
      transverse processes of the second and third cervical vertebrae. However, it may reach&#xD;
      caudally to the upper border of the fourth cervical vertebra.&#xD;
&#xD;
      Noradrenergic sympathetic nerve fibers mainly originating in the superior cervical ganglion,&#xD;
      accompanying the carotid artery supply cerebral vasculature particularly the pial vessels.&#xD;
&#xD;
      Superior cervical ganglion block was previously tried in managing neuropathic pain,&#xD;
      neuropathic pain in head and face region was investigated in patients using ganglionic local&#xD;
      opioid analgesia (GLOA) at the superior cervical ganglion (SCG) ,The short-term analgesic&#xD;
      effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p &lt;&#xD;
      0.001).&#xD;
&#xD;
      Superior cervical ganglion block also used as an alternative treatment to tinnitus not&#xD;
      responding to conventional therapy, it increases cholear blood flow and this can explain the&#xD;
      efficacy of block.&#xD;
&#xD;
      Superior cervical ganglion block was used to improve cerebral perfusion in patients with&#xD;
      cerebral vasospasm after aSAH.&#xD;
&#xD;
      Aneurysmal subarachnoid hemorrhage (aSAH) may develop vasospasm in 70% of patients.&#xD;
      Morphological changes occur in the cerebral vessels after SAH, and the inflammatory response&#xD;
      and local chemical agents are responsible for the induction of vasospasm.&#xD;
&#xD;
      Vasospasm is rare in the first 3 days after SAH, it reaches peak incidence at 7 to10 days and&#xD;
      usually resolves by 10 to14 days after SAH.&#xD;
&#xD;
      The sympathetic system also has a role in the pathogenesis of this process, cervical&#xD;
      sympathetic stimulation leads to constriction in intracerebral vessels and dilation occurs&#xD;
      when these fibers are interrupted. Efflux and reuptake of the neurotransmitter may be&#xD;
      prevented by sympathectomy.&#xD;
&#xD;
      Common treatments to reduce vasospasm include ;triple H therapy (hypertension ,hypervolemia&#xD;
      and hemodilution), intraarterial infusion of Smooth muscle relaxants (papaverine, Verapamil)&#xD;
      and endovascular balloon angioplasty . Also (nimodipine) calcium channel blocker&#xD;
      administration is used as a prophylactic measures.&#xD;
&#xD;
      Transcranial doppler (TCD) is a non-invasive technique which can be used to observe velocity,&#xD;
      direction and properties of blood flow in the cerebral arteries by means of a pulsed&#xD;
      ultrasonic beam, based on the Doppler effect of ultrasounds concerning frequency variations&#xD;
      in sound waves as a result of relative motion between source and signal receiver. It was&#xD;
      previously used in traumatic brain injury(TBI),stroke, anesthesia and intensive care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)</measure>
    <time_frame>The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 &amp; TCD7)</time_frame>
    <description>Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence or severity of MCA postoperative spasm over 14 days.</measure>
    <time_frame>within 14 days</time_frame>
    <description>TCD MCA vasospasm diagnostic criteria :&#xD;
Proximal MCA vasospasm can be diagnosed by any of the following:&#xD;
MCA Mean flow velocities of &gt; 200 cm/s, Rapid rise in flow velocities (&gt; 65 cm/s in one day), or Lindegaard ratio (VMCA/VICA &gt;6).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline heart rate</measure>
    <time_frame>Baseline (Before surgery) ,after induction the block and at the end of surgery</time_frame>
    <description>Heart rate will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline mean arterial blood pressure</measure>
    <time_frame>Baseline (Before surgery) ,after induction the block and at the end of surgery</time_frame>
    <description>Mean arterial blood pressure will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline oxygen saturation (Sao2)</measure>
    <time_frame>Baseline (Before surgery) ,after induction the block and at the end of surgery</time_frame>
    <description>Oxygen saturation (Sao2) will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).</measure>
    <time_frame>within 14 days</time_frame>
    <description>Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow coma scale</measure>
    <time_frame>Baseline (Preopetative), at day 3 and day 7</time_frame>
    <description>Glasgow coma scale will be calculated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Brain Aneurysm</condition>
  <condition>Aneurysm, Ruptured</condition>
  <arm_group>
    <arm_group_label>control study.</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>superior cervical block.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Superior Cervical Ganglion Block</intervention_name>
    <description>Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.</description>
    <arm_group_label>superior cervical block.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 18 to 70 years.&#xD;
&#xD;
          -  Genders eligible for study: both sexes.&#xD;
&#xD;
          -  ASA I-II.&#xD;
&#xD;
          -  GCS (13-15)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Contraindications to regional anesthesia (Bleeding disorders, Use of any&#xD;
             anti-coagulants, local infection).&#xD;
&#xD;
          -  Known allergy to local anesthetics.&#xD;
&#xD;
          -  ASA III-IV.&#xD;
&#xD;
          -  Patients aged less than 18 or more than 70.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatma Salman, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kasr El Aini Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>kasr Al Ainy hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25.</citation>
    <PMID>23438374</PMID>
  </reference>
  <reference>
    <citation>Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. doi: 10.1016/0006-8993(90)90831-u.</citation>
    <PMID>2282493</PMID>
  </reference>
  <reference>
    <citation>Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. doi: 10.1152/ajpheart.1988.255.3.H563.</citation>
    <PMID>3137827</PMID>
  </reference>
  <reference>
    <citation>Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27.</citation>
    <PMID>26311111</PMID>
  </reference>
  <reference>
    <citation>Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.</citation>
    <PMID>29107164</PMID>
  </reference>
  <reference>
    <citation>Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407.</citation>
    <PMID>27011639</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Fatma Ibrahim El Sayed Salman</investigator_full_name>
    <investigator_title>anesthesia assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>middle cerebral artery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Aneurysm, Ruptured</mesh_term>
  </condition_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/NCT04439760
org study id: transcranial Doppler
nct id: NCT04439760
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by
      transcranial doppler to determine the efficacy of SCG block in decreasing incidence or
      severity of vasospasm after MCA aneurysm surgery.
Sympathetic innervation to the face and head is by superior cervical ganglion(SCG), which is
      the most cranial part of the sympathetic chain. It is suited in a plication of the
      prevertebral fascia anterior to the longuscapitis muscle and dorsal to the internal carotid
      artery, posteromedial to the vagus nerve at c3 level. It's mainly located at the level of the
      transverse processes of the second and third cervical vertebrae. However, it may reach
      caudally to the upper border of the fourth cervical vertebra.

      Noradrenergic sympathetic nerve fibers mainly originating in the superior cervical ganglion,
      accompanying the carotid artery supply cerebral vasculature particularly the pial vessels.

      Superior cervical ganglion block was previously tried in managing neuropathic pain,
      neuropathic pain in head and face region was investigated in patients using ganglionic local
      opioid analgesia (GLOA) at the superior cervical ganglion (SCG) ,The short-term analgesic
      effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p <
      0.001).

      Superior cervical ganglion block also used as an alternative treatment to tinnitus not
      responding to conventional therapy, it increases cholear blood flow and this can explain the
      efficacy of block.

      Superior cervical ganglion block was used to improve cerebral perfusion in patients with
      cerebral vasospasm after aSAH.

      Aneurysmal subarachnoid hemorrhage (aSAH) may develop vasospasm in 70% of patients.
      Morphological changes occur in the cerebral vessels after SAH, and the inflammatory response
      and local chemical agents are responsible for the induction of vasospasm.

      Vasospasm is rare in the first 3 days after SAH, it reaches peak incidence at 7 to10 days and
      usually resolves by 10 to14 days after SAH.

      The sympathetic system also has a role in the pathogenesis of this process, cervical
      sympathetic stimulation leads to constriction in intracerebral vessels and dilation occurs
      when these fibers are interrupted. Efflux and reuptake of the neurotransmitter may be
      prevented by sympathectomy.

      Common treatments to reduce vasospasm include ;triple H therapy (hypertension ,hypervolemia
      and hemodilution), intraarterial infusion of Smooth muscle relaxants (papaverine, Verapamil)
      and endovascular balloon angioplasty . Also (nimodipine) calcium channel blocker
      administration is used as a prophylactic measures.

      Transcranial doppler (TCD) is a non-invasive technique which can be used to observe velocity,
      direction and properties of blood flow in the cerebral arteries by means of a pulsed
      ultrasonic beam, based on the Doppler effect of ultrasounds concerning frequency variations
      in sound waves as a result of relative motion between source and signal receiver. It was
      previously used in traumatic brain injury(TBI),stroke, anesthesia and intensive care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)
time frame: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)
description: Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler
measure: Incidence or severity of MCA postoperative spasm over 14 days.
time frame: within 14 days
description: TCD MCA vasospasm diagnostic criteria :
Proximal MCA vasospasm can be diagnosed by any of the following:
MCA Mean flow velocities of > 200 cm/s, Rapid rise in flow velocities (> 65 cm/s in one day), or Lindegaard ratio (VMCA/VICA >6).
measure: Change from baseline heart rate
time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
description: Heart rate will be measured
measure: Change from baseline mean arterial blood pressure
time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
description: Mean arterial blood pressure will be measured
measure: Change from baseline oxygen saturation (Sao2)
time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
description: Oxygen saturation (Sao2) will be measured
measure: Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).
time frame: within 14 days
description: Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted
measure: Glasgow coma scale
time frame: Baseline (Preopetative), at day 3 and day 7
description: Glasgow coma scale will be calculated
arm group label: control study.
arm group type: No Intervention
description: No intervention
arm group label: superior cervical block.
arm group type: Active Comparator
description: Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.
intervention type: Procedure
intervention name: Superior Cervical Ganglion Block
description: Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.
arm group label: superior cervical block.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fatma Salman, Master
role: Principal Investigator
affiliation: Kasr El Aini Hospital
facility: 
country: Egypt
citation: Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25.
PMID: 23438374
citation: Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. doi: 10.1016/0006-8993(90)90831-u.
PMID: 2282493
citation: Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. doi: 10.1152/ajpheart.1988.255.3.H563.
PMID: 3137827
citation: Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27.
PMID: 26311111
citation: Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.
PMID: 29107164
citation: Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407.
PMID: 27011639
responsible party type: Sponsor-Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Fatma Ibrahim El Sayed Salman
investigator title: anesthesia assistant lecturer
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Aneurysm, Ruptured