<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/NCT02976597</url>
  </required_header>
  <id_info>
    <org_study_id>17100234</org_study_id>
    <nct_id>NCT02976597</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided TAP Block for Postoperative Analgesia After Abdominal Surgery.</brief_title>
  <acronym>TAB</acronym>
  <official_title>Morphine as an Adjunct in Sonar Guided Transversus Abdominis Plane Block for Postoperative Analgesia in Patients Undergoing Abdominal Surgery.</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>
      Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that&#xD;
      involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides&#xD;
      adequate post-operative pain relieve following the various abdominal surgeries.&#xD;
      Theoretically, TAP block may replace the need for epidural analgesia after abdominal&#xD;
      operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by&#xD;
      (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior&#xD;
      abdomen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The transversus abdominis plane (TAP) technique, originally described by involves injection&#xD;
      of local anaesthetic in the plane between the internal oblique and transversus abdominis&#xD;
      muscle layers, with the aim of anaesthetising the intercostal nerves supplying the abdominal&#xD;
      wall. Initially, the block used surface landmarks of the triangle of Petit (latissimus dorsi&#xD;
      posteriorly, external oblique superiorly, iliac crest inferiorly) and a double fascial 'pop'&#xD;
      (loss of resistance) to guide placement of the local anaesthetic. More recently,&#xD;
      ultrasonography has been used to guide the delivery of the injectate into the appropriate&#xD;
      plane, thereby increasing the accuracy of the Technique.&#xD;
&#xD;
      The duration of the TAB is limited to effect of administered local anesthetics. To prolong&#xD;
      the block's duration, adjuvant medications were added to LA to magnify the effect of TAP&#xD;
      block . Opiates such as morphine and tramadol have peripheral and central analgesic effects.&#xD;
      Opiate receptors are present at the terminals of afferent peripheral nerves; therefore,&#xD;
      administration of opiates peripherally might provide a significant analgesic effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Verbal Rating Scale Score</measure>
    <time_frame>24 hours</time_frame>
    <description>The 24 hours postoperative verbal rating scale score on cough</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first request of rescue analgesia.</measure>
    <time_frame>24 hours</time_frame>
    <description>The total 24 hours consumption of analgesic drugs taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first request of rescue analgesics.</measure>
    <time_frame>24 hours</time_frame>
    <description>The time from end of the operation, PACU admission and the request for analgesic drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometric assessment</measure>
    <time_frame>24 hours</time_frame>
    <description>Measurment of lung function by spirometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>24 hours</time_frame>
    <description>Recording and treatment of adverse effects.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine 0.25%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine 10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphine 15mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.25% 20ml on each side Sonar guided TAB</intervention_name>
    <description>Bupivacaine 0.25% 20ml on each side Sonar guided TAP block. After careful aspiration injection of 20ml of 0.25% bupivacaine will be performed and hypoechoic layer will be detected on ultrasound then the maneuver will be repeated on the other side</description>
    <arm_group_label>Bupivacaine 0.25%</arm_group_label>
    <arm_group_label>Morphine 10mg</arm_group_label>
    <arm_group_label>Morphine 15mg</arm_group_label>
    <other_name>BUCAIN Sonar guided</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine 10mg</intervention_name>
    <description>Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.</description>
    <arm_group_label>Morphine 10mg</arm_group_label>
    <other_name>Morphine injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine 15mg</intervention_name>
    <description>Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.</description>
    <arm_group_label>Morphine 15mg</arm_group_label>
    <other_name>Morphine injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI&lt; 30kg/m2.&#xD;
&#xD;
          -  Age: 18-60 years.&#xD;
&#xD;
          -  Sex: both males and females.&#xD;
&#xD;
          -  ASA physical status: 1-II.&#xD;
&#xD;
          -  Operation: Abdominal laparotomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  History of cardiac disease, psychological disorders, respiratory diseases including&#xD;
             asthma, renal or hepatic failure.&#xD;
&#xD;
          -  Coagulation disorders.&#xD;
&#xD;
          -  Allergy to study medications.&#xD;
&#xD;
          -  Chronic use of pain medications.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Respiratory tract in-fection within the last 2 weeks.&#xD;
&#xD;
          -  Heavy smoker.&#xD;
&#xD;
          -  Histo-ry of abdominal surgery or trauma.&#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>Hala S Abdel-Ghaffar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hala Saad Abdel-Ghaffar</name>
      <address>
        <city>Asyut</city>
        <state>Assiut Governorate</state>
        <zip>715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hala Saad Abdel-Ghaffar</investigator_full_name>
    <investigator_title>Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.</investigator_title>
  </responsible_party>
  <keyword>Abdominal surgery, pain, local, transversus abdominus block.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT02976597
org study id: 17100234
nct id: NCT02976597
lead sponsor: 
has dmc: Yes
Transversus abdominis plane (TAP) block is a novel type of peripheral nerve block that
      involves innervations of the anterolateral abdominal wall derived from T6-L1.It provides
      adequate post-operative pain relieve following the various abdominal surgeries.
      Theoretically, TAP block may replace the need for epidural analgesia after abdominal
      operations. The oblique subcostal approach of the TAP (OSTAP) block, which was de¬scribed by
      (Hebbard et al, 2010) , has been reported to provide analgesia to the entire anterior
      abdomen.
The transversus abdominis plane (TAP) technique, originally described by involves injection
      of local anaesthetic in the plane between the internal oblique and transversus abdominis
      muscle layers, with the aim of anaesthetising the intercostal nerves supplying the abdominal
      wall. Initially, the block used surface landmarks of the triangle of Petit (latissimus dorsi
      posteriorly, external oblique superiorly, iliac crest inferiorly) and a double fascial 'pop'
      (loss of resistance) to guide placement of the local anaesthetic. More recently,
      ultrasonography has been used to guide the delivery of the injectate into the appropriate
      plane, thereby increasing the accuracy of the Technique.

      The duration of the TAB is limited to effect of administered local anesthetics. To prolong
      the block's duration, adjuvant medications were added to LA to magnify the effect of TAP
      block . Opiates such as morphine and tramadol have peripheral and central analgesic effects.
      Opiate receptors are present at the terminals of afferent peripheral nerves; therefore,
      administration of opiates peripherally might provide a significant analgesic effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Verbal Rating Scale Score
time frame: 24 hours
description: The 24 hours postoperative verbal rating scale score on cough
measure: Time to first request of rescue analgesia.
time frame: 24 hours
description: The total 24 hours consumption of analgesic drugs taken.
measure: Time to first request of rescue analgesics.
time frame: 24 hours
description: The time from end of the operation, PACU admission and the request for analgesic drugs.
measure: Spirometric assessment
time frame: 24 hours
description: Measurment of lung function by spirometry.
measure: Adverse effects
time frame: 24 hours
description: Recording and treatment of adverse effects.
arm group label: Bupivacaine 0.25%
arm group type: Active Comparator
description: Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side on each side at end of the surgery.
arm group label: Morphine 10mg
arm group type: Active Comparator
description: Morphine 10mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery.Patients will recieve 5mg morphine on each side
arm group label: Morphine 15mg
arm group type: Active Comparator
description: Morphine 15mg and Bupivacaine 0.25% 20ml will be administered for ultrasound guided TAP block on each side at end of the surgery. Patients will recieve 7.5mg morphine on each side
intervention type: Drug
intervention name: Bupivacaine 0.25% 20ml on each side Sonar guided TAB
description: Bupivacaine 0.25% 20ml on each side Sonar guided TAP block. After careful aspiration injection of 20ml of 0.25% bupivacaine will be performed and hypoechoic layer will be detected on ultrasound then the maneuver will be repeated on the other side
arm group label: Bupivacaine 0.25%
arm group label: Morphine 10mg
arm group label: Morphine 15mg
other name: BUCAIN Sonar guided
intervention type: Drug
intervention name: Morphine 10mg
description: Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.
arm group label: Morphine 10mg
other name: Morphine injection
intervention type: Drug
intervention name: Morphine 15mg
description: Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.
arm group label: Morphine 15mg
other name: Morphine injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hala S Abdel-Ghaffar, MD
role: Principal Investigator
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hala Saad Abdel-Ghaffar
investigator title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
mesh term: Pain, Postoperative
mesh term: Morphine
mesh term: Bupivacaine
sharing ipd: No