xml: <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/NCT06016816</url>
    </required_header>
    <id_info>
      <org_study_id>HTosunSoner</org_study_id>
      <nct_id>NCT06016816</nct_id>
    </id_info>
    <brief_title>The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery</brief_title>
    <official_title>The Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain in Patients to be Subject to Septorhinoplasty Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        The aim of this study is to examine the effects of bilateral sphenopalatine ganglion block on&#xD;
        surgical conditions, hemodynamics, intraoperative and postoperative analgesic use, recovery&#xD;
        characteristics, and postoperative pain during septorhinoplasty under general anesthesia. The&#xD;
        study was planned as double-blind, randomized, controlled. 72 patients who will undergo&#xD;
        septorhinoplasty surgery will be collected. (g power analysis was performed.) Evaluation of&#xD;
        the effectiveness of bilateral sphenopalatine ganglion block was planned. Patients will be&#xD;
        divided into 2 equal groups (36 patients). After the induction of general anesthesia, one&#xD;
        group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, the&#xD;
        other group (group:2) will be administered 4 cc saline. aspects will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale</measure>
      <time_frame>Postoperative 0-2 hours, 2-8 hours,8-24 hours</time_frame>
      <description>They will be numbered from 1 to 10.&#xD;
  1 mildest 10 most severe pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Riker Agitation Scale</measure>
      <time_frame>Immediately after extubation</time_frame>
      <description>7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A&#xD;
  1 Unarousable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean arterial pressure</measure>
      <time_frame>when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation</time_frame>
      <description>mmhg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate</measure>
      <time_frame>when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation</time_frame>
      <description>beats\minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>intraoperative remifentanil consumption</measure>
      <time_frame>intraoperative</time_frame>
      <description>The intraoperative ultiva infusion dose was recorded to the patient.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>edema questionnaire</measure>
      <time_frame>Postoperative 0-2 hours, 2-8 hours,8-24 hours</time_frame>
      <description>Periorbital edema was evaluated as present or absent questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hematoma questionnaire</measure>
      <time_frame>Postoperative 0-2 hours, 2-8 hours,8-24 hours</time_frame>
      <description>Hematoma was evaluated as present or absent questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>vomiting questionnaire</measure>
      <time_frame>Postoperative 0-2 hours, 2-8 hours,8-24 hours</time_frame>
      <description>was evaluated as present or absent questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral analgesic use</measure>
      <time_frame>In the first 24 hours after surgery</time_frame>
      <description>Analgesic use in the first 24 hours was questioned.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Anesthesia of Mucous Membrane</condition>
    <arm_group>
      <arm_group_label>Endoscopic bilateral sphenopalatine ganglion block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bilateral endoscopic sphenopalatine ganglion block</intervention_name>
      <description>After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,</description>
      <arm_group_label>Endoscopic bilateral sphenopalatine ganglion block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - patients with an ASA score of I-II and between the ages of 17-45 years, who were to&#xD;
          undergo general anesthesia with desflurane, were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients aged &lt;17 and &gt;45 years, patients with liver and/or kidney failure, obese&#xD;
               patients (BMI &gt;30), trauma patients, ASA III-IV patients, patients with bleeding&#xD;
               disorders, those using drugs that may affect the coagulation system, patients with&#xD;
               cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded&#xD;
               from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Health Sciences University Gazi Yaşargil Training and Research Hospital</name>
        <address>
          <city>Diyarbakır</city>
          <state>Kayapınar</state>
          <zip>21070</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Hülya Tosun Söner</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>sphenopalatine ganglion block</keyword>
    <keyword>septhorhinoplasty</keyword>
    <keyword>general anesthesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ganglion Cysts</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016816
  org study id: HTosunSoner
  nct id: NCT06016816
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to examine the effects of bilateral sphenopalatine ganglion block on
        surgical conditions, hemodynamics, intraoperative and postoperative analgesic use, recovery
        characteristics, and postoperative pain during septorhinoplasty under general anesthesia. The
        study was planned as double-blind, randomized, controlled. 72 patients who will undergo
        septorhinoplasty surgery will be collected. (g power analysis was performed.) Evaluation of
        the effectiveness of bilateral sphenopalatine ganglion block was planned. Patients will be
        divided into 2 equal groups (36 patients). After the induction of general anesthesia, one
        group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal, the
        other group (group:2) will be administered 4 cc saline. aspects will be evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Numeric Rating Scale
  time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
  description: They will be numbered from 1 to 10.
  1 mildest 10 most severe pain
  measure: Riker Agitation Scale
  time frame: Immediately after extubation
  description: 7 Dangerous Agitation 6 Very Agitated 5 Agitated 4 Calm and Cooperative 3 sedated 2 Very Sedated A
  1 Unarousable
  measure: mean arterial pressure
  time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
  description: mmhg
  measure: heart rate
  time frame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubation
  description: beats\minute
  measure: intraoperative remifentanil consumption
  time frame: intraoperative
  description: The intraoperative ultiva infusion dose was recorded to the patient.
  measure: edema questionnaire
  time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
  description: Periorbital edema was evaluated as present or absent questionnaire
  measure: hematoma questionnaire
  time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
  description: Hematoma was evaluated as present or absent questionnaire
  measure: vomiting questionnaire
  time frame: Postoperative 0-2 hours, 2-8 hours,8-24 hours
  description: was evaluated as present or absent questionnaire
  measure: Oral analgesic use
  time frame: In the first 24 hours after surgery
  description: Analgesic use in the first 24 hours was questioned.
  arm group label: Endoscopic bilateral sphenopalatine ganglion block
  arm group type: Active Comparator
  description: After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.
  intervention type: Procedure
  intervention name: Bilateral endoscopic sphenopalatine ganglion block
  description: After the induction of general anesthesia, one group (Group: 1) will be administered 8mg dexamethasone and 10mg bupivacaine submucosal,
  arm group label: Endoscopic bilateral sphenopalatine ganglion block
  intervention type: Procedure
  intervention name: placebo
  description: Placebo group (group:2) will be administered 4 cc saline. aspects will be evaluated.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Hülya Tosun Söner
  investigator title: Principal Investigator
  mesh term: Ganglion Cysts
  mesh term: Pain, Postoperative
  sharing ipd: No