<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/NCT03776617</url>
  </required_header>
  <id_info>
    <org_study_id>ScalCran</org_study_id>
    <nct_id>NCT03776617</nct_id>
  </id_info>
  <brief_title>Scalp Block in Elective Craniotomy for Tumor Dissection Trial</brief_title>
  <official_title>Regional Scalp Block With Ropivacaine 0.5% in Patients Undergoing Elective Craniotomy: a Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Papanicolaou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Papanicolaou 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>
      This study was designed to evaluate the effect of scalp block combined with general&#xD;
      anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients&#xD;
      undergoing elective craniotomy. Scalp block will be applied to three groups with differences&#xD;
      of the administered solution to the scalp and one group will be placebo group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional scalp block (RSB) is an established technique that involves infiltration of local&#xD;
      anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of&#xD;
      the scalp. Regional techniques minimize anesthetic requirements and their effects may be&#xD;
      beneficial. There is a lack of consensus and evidence concerning alternative analgesia&#xD;
      strategies for cranial neurosurgery.&#xD;
&#xD;
      Patients undergoing elective craniotomy for tumor dissection will be randomly divided into&#xD;
      four groups to receive scalp block as an adjuvant to general anesthesia. After a standard&#xD;
      induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be&#xD;
      intubated. Bilateral scalp block will be given immediately after induction, except patients&#xD;
      in control group who will not have a scalp block. Drugs for scalp block will be 20ml&#xD;
      ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be&#xD;
      maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75&#xD;
      to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five&#xD;
      minutes before head pinning scalp block was performed by blocking the supraorbital,&#xD;
      supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater&#xD;
      auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial&#xD;
      blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia&#xD;
      until 10 minutes after incision, followed by 5-minute intervals throughout the remaining&#xD;
      course of the surgery. Monitoring of the depth of anesthesia will also performed using the&#xD;
      Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80%&#xD;
      and minimum difference d = 30%, which is clinically significant in the pilot study. All&#xD;
      quantitative variables will be reported as mean and standard deviation, and qualitative&#xD;
      variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will&#xD;
      be used for comparison of endpoints. Linear mixed model will be used to evaluate the&#xD;
      differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version&#xD;
      19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will&#xD;
      be considered significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 5, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intraoperative opioid consumption</measure>
    <time_frame>intraoperative</time_frame>
    <description>The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>systolic arterial pressure and diastolic arterial pressure</measure>
    <time_frame>intraoperative</time_frame>
    <description>The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>heart rate fluctuation</measure>
    <time_frame>intraoperative</time_frame>
    <description>heart rate change from baseline will be calculated. The unit for heart rate is bpm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>extubation time</measure>
    <time_frame>one day</time_frame>
    <description>Time from the end of anesthetic to fully awake and extubation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>chronic pain after craniotomy</measure>
    <time_frame>3 months after craniotomy</time_frame>
    <description>telephone after 3 months and ask for pain description using the Numeric Pain Rating Scale (NPRS). A respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Craniotomy</condition>
  <arm_group>
    <arm_group_label>Group Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Ropivacaine-Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>general anesthesia + Scalp block with 40ml Normal Saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>scalp block</intervention_name>
    <description>Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.</description>
    <arm_group_label>Group Ropivacaine</arm_group_label>
    <arm_group_label>Group Ropivacaine-Dexmedetomidine</arm_group_label>
    <arm_group_label>Group sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with American Society of Anesthesiologists Physical status classification 1-3&#xD;
&#xD;
          -  patients who are scheduled for elective craniotomy for brain tumor&#xD;
&#xD;
          -  patients who have provided consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have allergy to local anesthetics and dexmedetomidine&#xD;
&#xD;
          -  Glasgow coma scale &lt;15&#xD;
&#xD;
          -  tumor&gt;4cm&#xD;
&#xD;
          -  any contraindication for receiving dexmedetomidine&#xD;
&#xD;
          -  severe mental impairment&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  uncontrolled hypertension, arrhythmia, coagulation disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anastasia Trikoupi, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>General Hospital of Thessaloniki</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chrysoula Stachtari, MD, PhD</last_name>
    <phone>+306946140458</phone>
    <email>chryssastachtari@yahoo.gr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zoi Stergiouda, MD</last_name>
    <phone>+306942403938</phone>
    <email>zstergiouda@yahoo.gr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>George Papanikoalou Hospital</name>
      <address>
        <city>Thessaloníki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chrysoula Stachtari, MD, PhD</last_name>
      <email>chryssastachtari@yahoo.gr</email>
    </contact>
    <contact_backup>
      <last_name>Zoi Stergiouda, MD</last_name>
      <email>zstergiouda@yahoo.gr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>May 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Papanicolaou Hospital</investigator_affiliation>
    <investigator_full_name>Stachtari Chrysoula MD, PhD</investigator_full_name>
    <investigator_title>Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou Hospital</investigator_title>
  </responsible_party>
  <keyword>scalp block</keyword>
  <keyword>craniotomy</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>ropivacaine</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776617
org study id: ScalCran
nct id: NCT03776617
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was designed to evaluate the effect of scalp block combined with general
      anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients
      undergoing elective craniotomy. Scalp block will be applied to three groups with differences
      of the administered solution to the scalp and one group will be placebo group.
Regional scalp block (RSB) is an established technique that involves infiltration of local
      anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of
      the scalp. Regional techniques minimize anesthetic requirements and their effects may be
      beneficial. There is a lack of consensus and evidence concerning alternative analgesia
      strategies for cranial neurosurgery.

      Patients undergoing elective craniotomy for tumor dissection will be randomly divided into
      four groups to receive scalp block as an adjuvant to general anesthesia. After a standard
      induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be
      intubated. Bilateral scalp block will be given immediately after induction, except patients
      in control group who will not have a scalp block. Drugs for scalp block will be 20ml
      ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be
      maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75
      to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five
      minutes before head pinning scalp block was performed by blocking the supraorbital,
      supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater
      auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial
      blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia
      until 10 minutes after incision, followed by 5-minute intervals throughout the remaining
      course of the surgery. Monitoring of the depth of anesthesia will also performed using the
      Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80%
      and minimum difference d = 30%, which is clinically significant in the pilot study. All
      quantitative variables will be reported as mean and standard deviation, and qualitative
      variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will
      be used for comparison of endpoints. Linear mixed model will be used to evaluate the
      differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version
      19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will
      be considered significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: intraoperative opioid consumption
time frame: intraoperative
description: The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.
measure: systolic arterial pressure and diastolic arterial pressure
time frame: intraoperative
description: The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.
measure: heart rate fluctuation
time frame: intraoperative
description: heart rate change from baseline will be calculated. The unit for heart rate is bpm
measure: extubation time
time frame: one day
description: Time from the end of anesthetic to fully awake and extubation
measure: chronic pain after craniotomy
time frame: 3 months after craniotomy
description: telephone after 3 months and ask for pain description using the Numeric Pain Rating Scale (NPRS). A respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
arm group label: Group Ropivacaine
arm group type: Experimental
description: general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5%
arm group label: Group Ropivacaine-Dexmedetomidine
arm group type: Experimental
description: general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine
arm group label: Group control
arm group type: No Intervention
description: general anesthesia
arm group label: Group sham
arm group type: Sham Comparator
description: general anesthesia + Scalp block with 40ml Normal Saline
intervention type: Procedure
intervention name: scalp block
description: Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.
arm group label: Group Ropivacaine
arm group label: Group Ropivacaine-Dexmedetomidine
arm group label: Group sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anastasia Trikoupi, MD, PhD
role: Study Director
affiliation: General Hospital of Thessaloniki
last name: Chrysoula Stachtari, MD, PhD
phone: +306946140458
email: chryssastachtari@yahoo.gr
last name: Zoi Stergiouda, MD
phone: +306942403938
email: zstergiouda@yahoo.gr
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: George Papanicolaou Hospital
investigator full name: Stachtari Chrysoula MD, PhD
investigator title: Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou Hospital
sharing ipd: No