<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/NCT02970058</url>
  </required_header>
  <id_info>
    <org_study_id>01003060392</org_study_id>
    <nct_id>NCT02970058</nct_id>
  </id_info>
  <brief_title>Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery</brief_title>
  <official_title>Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following&#xD;
      gynecological surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Anticipated">July 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Platelet-rich Plasma in Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Platelet-rich Plasma</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients will receive platelet-rich plasma post-spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 patients will receive sterile saline post-spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Platelet-rich Plasma</intervention_name>
    <description>The active group will receive Platelet-rich Plasma following spinal injection</description>
    <arm_group_label>Platelet-rich Plasma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The control group will receive saline as a placebo</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective gynecological surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Spinal Pathology&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>mohmed Bakri, prof</last_name>
    <phone>+20882413201</phone>
    <email>mhbakri@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 13, 2020</last_update_submitted>
  <last_update_submitted_qc>March 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Eman A. Ismail</investigator_full_name>
    <investigator_title>Lecturer of anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT02970058
org study id: 01003060392
nct id: NCT02970058
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following
      gynecological surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual Analogue Scale
time frame: 7 days
arm group label: Platelet-rich Plasma
arm group type: Active Comparator
description: 30 patients will receive platelet-rich plasma post-spinal anesthesia
arm group label: Control
arm group type: Placebo Comparator
description: 30 patients will receive sterile saline post-spinal anesthesia
intervention type: Other
intervention name: Platelet-rich Plasma
description: The active group will receive Platelet-rich Plasma following spinal injection
arm group label: Platelet-rich Plasma
intervention type: Other
intervention name: Control
description: The control group will receive saline as a placebo
arm group label: Control
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: mohmed Bakri, prof
phone: +20882413201
email: mhbakri@gmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Eman A. Ismail
investigator title: Lecturer of anesthesia
mesh term: Back Pain
mesh term: Low Back Pain