<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/NCT04479176</url>
  </required_header>
  <id_info>
    <org_study_id>AJIRB-MED-MDB-20-565</org_study_id>
    <nct_id>NCT04479176</nct_id>
  </id_info>
  <brief_title>Comparison of Two Methods of Transnasal Sphenopalatine Ganglion Block</brief_title>
  <official_title>Comparison of Temperature and Pain Changes Between the Drip and Topical Methods of Administering the Transnasal Sphenopalatine Ganglion Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</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 transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or&#xD;
      head and neck pain. In the transnasal approach, the drip and topical methods are frequently&#xD;
      used. We compared facial temperatures and VAS after transnasal SPGB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study was to compare facial temperatures and visual analogue scale&#xD;
      (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block&#xD;
      (SPGB).&#xD;
&#xD;
      The transnasal SPGB is administered to patients with facial or head and neck pain. In the&#xD;
      transnasal approach, the drip and topical methods are frequently used. We compared facial&#xD;
      temperatures and VAS after transnasal SPGB.&#xD;
&#xD;
      Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were&#xD;
      retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were&#xD;
      divided into the drip-method and topical-method groups. Facial temperatures were measured in&#xD;
      six areas of the right and left forehead, maxilla, and mandible before and 30 min after&#xD;
      completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in&#xD;
      each group and between the two groups. VAS scores were compared at same times of SPGB in each&#xD;
      group and between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2021</start_date>
  <completion_date type="Actual">October 1, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Facial temperatures</measure>
    <time_frame>Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block</time_frame>
    <description>Facial temeratures changes after transnasal SPGB</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale(VAS)</measure>
    <time_frame>Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block</time_frame>
    <description>11 points pain scale score from 0 to 10</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Sphenopalatine Ganglion Block</condition>
  <arm_group>
    <arm_group_label>Drip-method group</arm_group_label>
    <description>Transnasal SPGB was performed by a single pain clinician. After the patient was placed in a supine and neck-extended position, 2 mL of 2% mepivacaine was placed in a syringe connected to a 16-gauge Angiocath sheath. The sheath of the Angiocath was inserted through the nostril, and 2% mepivacaine was dripped into the nostrils with the patient in a supine position. The mepivacaine drip on the nasal pharynx was maintained for 10 min. A drip of 2% mepivacaine was delivered to the nostril, where the pain was dominant. In cases of bilateral pain, mepivacaine drip was administered to both nostrils.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical-method group</arm_group_label>
    <description>Transnasal SPGB was performed by a single pain clinician. The posture was the same as that in the drip method. A cotton tip applicator soaked with 2% mepivacaine was inserted vertically into the nostril. After the cotton tip applicator made contact with the posterior wall of the middle turbinate, the cotton tip applicator was fixed for 10 min. A cotton tip applicator was inserted into the nostril, where the pain was dominant. In cases of bilateral pain, two applicators were inserted into both nostrils.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transnasal Sphenopalatine Ganglion Block</intervention_name>
    <description>In transnasal approach, several authors described the traditional technique using sterile 10cm cotton tipped applicators that are dipped in the chosen anesthetic and then advanced along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx. Some other techniques had described dripping one or two ml of the anesthetics into the nostril.</description>
    <arm_group_label>Drip-method group</arm_group_label>
    <arm_group_label>Topical-method group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who visited pain clinic of Ajou university hospital, and a total of 74&#xD;
        patients who be performed transnasal sphenopalatine ganglion block&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) age over 20 years ; (2) head and neck pain; (3) pain score &gt; 4 on the VAS in the head&#xD;
        and neck; and (4) having undergone a transnasal SPGB and having had facial temperatures&#xD;
        measured.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) patients with a history of head and neck surgery, (2) treatment with a vasodilator or&#xD;
        vasoconstrictor, (3) contraindication to treatment using a transnasal approach, (4)&#xD;
        clinically significant systemic disease or any reduced organ failure, and (5) missing data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim</last_name>
    <role>Study Chair</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ajou University Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyunggi</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>October 12, 2021</last_update_submitted>
  <last_update_submitted_qc>October 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jong Bum Choi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>
  </condition_browse>
  <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/NCT04479176
org study id: AJIRB-MED-MDB-20-565
nct id: NCT04479176
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The transnasal sphenopalatine ganglion block(SPGB) is administered to patients with facial or
      head and neck pain. In the transnasal approach, the drip and topical methods are frequently
      used. We compared facial temperatures and VAS after transnasal SPGB.
The objective of this study was to compare facial temperatures and visual analogue scale
      (VAS) between drip method and topical method of transnasal sphenopalatine ganglion block
      (SPGB).

      The transnasal SPGB is administered to patients with facial or head and neck pain. In the
      transnasal approach, the drip and topical methods are frequently used. We compared facial
      temperatures and VAS after transnasal SPGB.

      Medical records of 74 patients who visited the pain clinic and underwent transnasal SPGB were
      retrospectively reviewed. A total of 156 transnasal SPGB were performed. The patients were
      divided into the drip-method and topical-method groups. Facial temperatures were measured in
      six areas of the right and left forehead, maxilla, and mandible before and 30 min after
      completion of the transnasal SPGB. Temperatures were compared before and 30 min after SPGB in
      each group and between the two groups. VAS scores were compared at same times of SPGB in each
      group and between the two groups.
observational model: Case-Control
time perspective: Retrospective
measure: Facial temperatures
time frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
description: Facial temeratures changes after transnasal SPGB
measure: Visual analogue scale(VAS)
time frame: Before, and 30 minutes after completion of transnasal sphenopalatine ganglion block
description: 11 points pain scale score from 0 to 10
arm group label: Drip-method group
description: Transnasal SPGB was performed by a single pain clinician. After the patient was placed in a supine and neck-extended position, 2 mL of 2% mepivacaine was placed in a syringe connected to a 16-gauge Angiocath sheath. The sheath of the Angiocath was inserted through the nostril, and 2% mepivacaine was dripped into the nostrils with the patient in a supine position. The mepivacaine drip on the nasal pharynx was maintained for 10 min. A drip of 2% mepivacaine was delivered to the nostril, where the pain was dominant. In cases of bilateral pain, mepivacaine drip was administered to both nostrils.
arm group label: Topical-method group
description: Transnasal SPGB was performed by a single pain clinician. The posture was the same as that in the drip method. A cotton tip applicator soaked with 2% mepivacaine was inserted vertically into the nostril. After the cotton tip applicator made contact with the posterior wall of the middle turbinate, the cotton tip applicator was fixed for 10 min. A cotton tip applicator was inserted into the nostril, where the pain was dominant. In cases of bilateral pain, two applicators were inserted into both nostrils.
intervention type: Procedure
intervention name: Transnasal Sphenopalatine Ganglion Block
description: In transnasal approach, several authors described the traditional technique using sterile 10cm cotton tipped applicators that are dipped in the chosen anesthetic and then advanced along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx. Some other techniques had described dripping one or two ml of the anesthetics into the nostril.
arm group label: Drip-method group
arm group label: Topical-method group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kim
role: Study Chair
affiliation: Ajou University School of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jong Bum Choi
investigator title: Assistant Professor
mesh term: Ganglion Cysts
mesh term: Synovial Cyst
sharing ipd: No