<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/NCT03285282</url>
  </required_header>
  <id_info>
    <org_study_id>123/2017</org_study_id>
    <nct_id>NCT03285282</nct_id>
  </id_info>
  <brief_title>Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery</brief_title>
  <official_title>Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several regional anesthesia have been shown to improve postoperative outcomes in many&#xD;
      studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal&#xD;
      wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This&#xD;
      work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane&#xD;
      block (analogous to the TAP block but intended for the back) which targets the sensory&#xD;
      component of the dorsal rami of the thoracolumbar nerves in patients undergoing back&#xD;
      surgeries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 8, 2017</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>Early Phase 1</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Score</measure>
    <time_frame>24 hrs postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total morphine consumption</measure>
    <time_frame>24 hrs postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Analgesia After Disc Surgery</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thoracolumber interfascial plane block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracolumber interfascial plane block</intervention_name>
    <description>Thoracolumber interfascial plane block versus placebo</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex&#xD;
             scheduled of back surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will be patients refusal or inability to give an informed consent ,&#xD;
             history of relevant allergy to any of the drugs used in the procedure , previous&#xD;
             lumbar spine surgery or back surgery with planed spinal fixation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mona Ammar, MD</last_name>
    <phone>01006236620</phone>
    <email>Mona_3mmar@Hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Taeimah, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of medicine</name>
      <address>
        <city>Cairo</city>
        <zip>1234</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waleed Abdalla, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mona Ammar</investigator_full_name>
    <investigator_title>Lecture of anesthesia,intensive care and pain management</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03285282
org study id: 123/2017
nct id: NCT03285282
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Several regional anesthesia have been shown to improve postoperative outcomes in many
      studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal
      wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This
      work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane
      block (analogous to the TAP block but intended for the back) which targets the sensory
      component of the dorsal rami of the thoracolumbar nerves in patients undergoing back
      surgeries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Visual Analogue Score
time frame: 24 hrs postoperative
measure: Total morphine consumption
time frame: 24 hrs postoperative
arm group label: Intervention
arm group type: Active Comparator
description: Thoracolumber interfascial plane block
arm group label: Control
arm group type: No Intervention
intervention type: Procedure
intervention name: Thoracolumber interfascial plane block
description: Thoracolumber interfascial plane block versus placebo
arm group label: Intervention
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mona Ammar, MD
phone: 01006236620
email: Mona_3mmar@Hotmail.com
last name: Mohamed Taeimah, MD
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mona Ammar
investigator title: Lecture of anesthesia,intensive care and pain management
mesh term: Agnosia
sharing ipd: Undecided