<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/NCT04401878</url>
  </required_header>
  <id_info>
    <org_study_id>6140</org_study_id>
    <secondary_id>6140</secondary_id>
    <nct_id>NCT04401878</nct_id>
  </id_info>
  <brief_title>SGB in Management of Patients With PDPH Using TCD</brief_title>
  <official_title>Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</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 aims to investigate the ability of SPGB in the management of PDPH. Transcranial&#xD;
      Doppler is also used as an measure to assess the block success by detecting the variability&#xD;
      in the cerebral hemodynamics before and after the block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is performed in postoperative orthopedic unit. In this study, 120&#xD;
      patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined&#xD;
      the treatment group (A) and received the SP block. They are assessed before the procedure by&#xD;
      NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed&#xD;
      by TCD before and after the block. The control group (B) included 60 patients with no PDPH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2020</start_date>
  <completion_date type="Actual">September 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Double (Care Providor, Outcome Assessor)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>pain changes assessment by numeric rating scale (NRS)</measure>
    <time_frame>Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block</time_frame>
    <description>Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS ≤ 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detecting the changes in cerebral vessels caliber after doing SPGB</measure>
    <time_frame>TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.</time_frame>
    <description>Siemens Acuson X300 ultrasound with P 4-2 phased array 2MHz probe was utilized. For all patients, both middle cerebral arteries were insonated through the transtemporal window over the zygomatic arch in front of the tragus of the ear at a depth of 50-60 mm. Tracings were also recorded for at least 10 cardiac cycles</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Post-Dural Puncture Headache</condition>
  <arm_group>
    <arm_group_label>the treatment group (A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group (B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group (B) of 60 patients with no PDPH were examined by TCD</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sphenopalatine Ganglion Block using 2% lidocaine</intervention_name>
    <description>Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.</description>
    <arm_group_label>control group (B)</arm_group_label>
    <arm_group_label>the treatment group (A)</arm_group_label>
    <other_name>Transcranial Doppler (TCD) is also utilized</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients are considered who had an epidural anesthesia&#xD;
&#xD;
          -  Patients with ASA 1 and 2&#xD;
&#xD;
          -  Patients' age ranged from 18 to 60 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with septal perforation, nasal septum deviation,or nasal bleeding.&#xD;
&#xD;
          -  Patients have recent nasal trauma&#xD;
&#xD;
          -  Patients have recent nasal surgery&#xD;
&#xD;
          -  Patients have a nasal infection&#xD;
&#xD;
          -  Patients within ASA 3 and 4&#xD;
&#xD;
          -  Patients older than sixty yrs or younger than eighteen yrs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naglaa Abdelhaleem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Zagazig University, Zagazig, Egypt.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.</citation>
    <PMID>26176166</PMID>
  </reference>
  <results_reference>
    <citation>Abdelhaleem NF, Othman HA, Abdel Razek GM, et al. (2019). Is the Combination of Glasgow Coma Scale and Transcranial Doppler Pulsatility Index Improving the Prediction of Outcome in Traumatic Brain Injury Patients? ZUMJ, 2019, 25(5): 529-538, doi:10.21608/zumj.2019.10082.10740</citation>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 18, 2021</last_update_submitted>
  <last_update_submitted_qc>July 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Naglaa Fathy Abdelhaleem Abdelhaleem</investigator_full_name>
    <investigator_title>Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine</investigator_title>
  </responsible_party>
  <keyword>Accidental dural puncture</keyword>
  <keyword>Post dural puncture headache</keyword>
  <keyword>Sphenopalatine ganglion block</keyword>
  <keyword>Transcranial Doppler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Dural Puncture Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>it will be available after completion of study and publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The data will be available 3 months after publication of study</ipd_time_frame>
    <ipd_access_criteria>By contacting the principal investigator</ipd_access_criteria>
    <ipd_url>https://ClinicalTrials.gov</ipd_url>
  </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/NCT04401878
org study id: 6140
secondary id: 6140
nct id: NCT04401878
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial
      Doppler is also used as an measure to assess the block success by detecting the variability
      in the cerebral hemodynamics before and after the block.
This clinical trial is performed in postoperative orthopedic unit. In this study, 120
      patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined
      the treatment group (A) and received the SP block. They are assessed before the procedure by
      NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed
      by TCD before and after the block. The control group (B) included 60 patients with no PDPH.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: Double (Care Providor, Outcome Assessor)
measure: pain changes assessment by numeric rating scale (NRS)
time frame: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
description: Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS ≤ 4.
measure: Detecting the changes in cerebral vessels caliber after doing SPGB
time frame: TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.
description: Siemens Acuson X300 ultrasound with P 4-2 phased array 2MHz probe was utilized. For all patients, both middle cerebral arteries were insonated through the transtemporal window over the zygomatic arch in front of the tragus of the ear at a depth of 50-60 mm. Tracings were also recorded for at least 10 cardiac cycles
arm group label: the treatment group (A)
arm group type: Experimental
description: Patients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block.
arm group label: control group (B)
arm group type: Experimental
description: The control group (B) of 60 patients with no PDPH were examined by TCD
intervention type: Drug
intervention name: Sphenopalatine Ganglion Block using 2% lidocaine
description: Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.
arm group label: control group (B)
arm group label: the treatment group (A)
other name: Transcranial Doppler (TCD) is also utilized
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Naglaa Abdelhaleem, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Zagazig University, Zagazig, Egypt.
facility: 
country: Egypt
citation: Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.
PMID: 26176166
citation: Abdelhaleem NF, Othman HA, Abdel Razek GM, et al. (2019). Is the Combination of Glasgow Coma Scale and Transcranial Doppler Pulsatility Index Improving the Prediction of Outcome in Traumatic Brain Injury Patients? ZUMJ, 2019, 25(5): 529-538, doi:10.21608/zumj.2019.10082.10740
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Naglaa Fathy Abdelhaleem Abdelhaleem
investigator title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine
mesh term: Post-Dural Puncture Headache
mesh term: Headache
mesh term: Lidocaine
sharing ipd: Yes
ipd description: it will be available after completion of study and publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The data will be available 3 months after publication of study
ipd access criteria: By contacting the principal investigator
ipd url: https://ClinicalTrials.gov