<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/NCT03002909</url>
  </required_header>
  <id_info>
    <org_study_id>369</org_study_id>
    <nct_id>NCT03002909</nct_id>
  </id_info>
  <brief_title>Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery</brief_title>
  <official_title>Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine&#xD;
      wound infiltration versus epidural analgesia on the inflammatory cytokines response following&#xD;
      radical cytectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in the level of inflammatory cytokines in pg /ml</measure>
    <time_frame>24 hours</time_frame>
    <description>Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale at rest and on coughing</measure>
    <time_frame>24 hours</time_frame>
    <description>pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>opioid side-effects</measure>
    <time_frame>24 hours</time_frame>
    <description>observation of side effects and record incidence as nausea, vomiting and itching</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>24 hours</time_frame>
    <description>scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Abdominal Neoplasms</condition>
  <arm_group>
    <arm_group_label>epidural group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preperitoneal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>epidural catheter</intervention_name>
    <arm_group_label>epidural group</arm_group_label>
    <other_name>PEA block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>preperitoneal catheter</intervention_name>
    <arm_group_label>preperitoneal group</arm_group_label>
    <other_name>preperitoneal infusion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-III patients&#xD;
&#xD;
          -  aged 18-60 yr&#xD;
&#xD;
          -  undergo open abdominal cancer surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  general contraindications for epidural analgesia,&#xD;
&#xD;
          -  recent history (8 weeks) of, chemotherapy or radiation,&#xD;
&#xD;
          -  chronic opioid use&#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>fatma el sherif, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>south Egypt cancer institute - assuit university</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmad M Abd El-Rahman, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of anesthesia, icu, and pain management</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Egypt Cancer instIitute</name>
      <address>
        <city>Assuit</city>
        <zip>171516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>October 7, 2018</last_update_submitted>
  <last_update_submitted_qc>October 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Fatma Adel El sherif,MD</investigator_full_name>
    <investigator_title>lecturer of anesthesia ,icu and pain management</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abdominal Neoplasms</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/NCT03002909
org study id: 369
nct id: NCT03002909
lead sponsor: 
has dmc: Yes
the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine
      wound infiltration versus epidural analgesia on the inflammatory cytokines response following
      radical cytectomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Investigator)
measure: changes in the level of inflammatory cytokines in pg /ml
time frame: 24 hours
description: Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines
measure: Visual Analog Scale at rest and on coughing
time frame: 24 hours
description: pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)
measure: opioid side-effects
time frame: 24 hours
description: observation of side effects and record incidence as nausea, vomiting and itching
measure: patient satisfaction
time frame: 24 hours
description: scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)
arm group label: epidural group
arm group type: Active Comparator
description: an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. .
arm group label: preperitoneal group
arm group type: Active Comparator
description: preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.
intervention type: Device
intervention name: epidural catheter
arm group label: epidural group
other name: PEA block
intervention type: Device
intervention name: preperitoneal catheter
arm group label: preperitoneal group
other name: preperitoneal infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: fatma el sherif, M.D
role: Principal Investigator
affiliation: south Egypt cancer institute - assuit university
last name: Ahmad M Abd El-Rahman, M.D
role: Study Director
affiliation: Lecturer of anesthesia, icu, and pain management
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Fatma Adel El sherif,MD
investigator title: lecturer of anesthesia ,icu and pain management
mesh term: Abdominal Neoplasms
sharing ipd: Undecided