<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/NCT03769818</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/181/18</org_study_id>
    <nct_id>NCT03769818</nct_id>
  </id_info>
  <brief_title>Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy</brief_title>
  <official_title>Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aswan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aswan University Hospital</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>
      The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine&#xD;
      0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing&#xD;
      total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg&#xD;
&#xD;
        -  Group 2: bupivacaine 0.25%&#xD;
&#xD;
        -  Group3: control group A prospective Randomized Interventional double-blind study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Optimal dynamic analgesia is recognized as the key to enhanced recovery following open&#xD;
      abdominal surgery. In the last decade, there has been a significant shift away from thoracic&#xD;
      epidural analgesia (TEA) that has been long considered as the gold standard. Various&#xD;
      techniques have tried to replicate the analgesic efficacy of TEA. They include transversus&#xD;
      abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI)&#xD;
      and trans muscular quadratus lumborum analgesia. However, each of these techniques has&#xD;
      specific limitations that prevent them from being the analgesic technique of choice for all&#xD;
      open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for&#xD;
      providing analgesia following ventral hernia repair. The unique feature of the&#xD;
      ultrasound-guided truncal blocks is that in all of these techniques, in contrast to&#xD;
      peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is&#xD;
      injected in a particular muscle plane, in which the injectate spreads and reaches the&#xD;
      intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 30, 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>
    <intervention_model_description>A prospective Randomized Interventional double-blind study.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analog score for pain during movement</measure>
    <time_frame>24 hours post operative</time_frame>
    <description>movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analog score for pain during rest</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>ranging from 0 to 10, where 0 no pain and 10 maximum pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients need Fentanyl consumption</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>calculation of the number of patients need Fentanyl consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of days patients stay in hospital</measure>
    <time_frame>4 weeks</time_frame>
    <description>calculation of number of days patients stay in hospital</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>bupivacaine and dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacaine and placebo to dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <description>Bilateral TAP block with 20 ml of 0.25% bupivacaine</description>
    <arm_group_label>bupivacaine and dexamethasone</arm_group_label>
    <arm_group_label>bupivacaine and placebo to dexamethasone</arm_group_label>
    <other_name>Active Comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone</intervention_name>
    <description>Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.</description>
    <arm_group_label>bupivacaine and dexamethasone</arm_group_label>
    <other_name>active comparator</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to dexamethasone</intervention_name>
    <description>Bilateral TAP block with placebo to dexamethasone.</description>
    <arm_group_label>bupivacaine and placebo to dexamethasone</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo to bupivacaine</intervention_name>
    <description>Bilateral TAP block with placebo to bupivacaine.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ranging age between 30-60 years a who undergoing elective total abdominal&#xD;
             hysterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants had known sensitivity to bupivacaine&#xD;
&#xD;
          -  Participants had difficulty in intubation&#xD;
&#xD;
          -  Participants were on chronic pain medication or already on long-term opioids&#xD;
&#xD;
          -  Participants smokers&#xD;
&#xD;
          -  Participants with disabilities who were unable to communicate pain levels&#xD;
&#xD;
          -  refuse to consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>patients undergoing total abdominal hysterectomy</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hany f sallam, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aswan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aswan University</name>
      <address>
        <city>Aswan</city>
        <zip>81528</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aswan University Hospital</investigator_affiliation>
    <investigator_full_name>hany farouk</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>erector spinae plane block</keyword>
  <keyword>total abdominal hysterectomy</keyword>
  <keyword>dexamethasone</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>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_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/NCT03769818
org study id: aswu/181/18
nct id: NCT03769818
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine
      0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing
      total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

        -  Group 2: bupivacaine 0.25%

        -  Group3: control group A prospective Randomized Interventional double-blind study.
Optimal dynamic analgesia is recognized as the key to enhanced recovery following open
      abdominal surgery. In the last decade, there has been a significant shift away from thoracic
      epidural analgesia (TEA) that has been long considered as the gold standard. Various
      techniques have tried to replicate the analgesic efficacy of TEA. They include transversus
      abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI)
      and trans muscular quadratus lumborum analgesia. However, each of these techniques has
      specific limitations that prevent them from being the analgesic technique of choice for all
      open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for
      providing analgesia following ventral hernia repair. The unique feature of the
      ultrasound-guided truncal blocks is that in all of these techniques, in contrast to
      peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is
      injected in a particular muscle plane, in which the injectate spreads and reaches the
      intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective Randomized Interventional double-blind study.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete for group 1 and 2.
measure: Visual analog score for pain during movement
time frame: 24 hours post operative
description: movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
measure: Visual analog score for pain during rest
time frame: 24 hours postoperative
description: ranging from 0 to 10, where 0 no pain and 10 maximum pain
measure: number of patients need Fentanyl consumption
time frame: 24 hours postoperative
description: calculation of the number of patients need Fentanyl consumption
measure: number of days patients stay in hospital
time frame: 4 weeks
description: calculation of number of days patients stay in hospital
arm group label: bupivacaine and dexamethasone
arm group type: Active Comparator
description: Bilateral ESP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.
arm group label: bupivacaine and placebo to dexamethasone
arm group type: Active Comparator
description: Bilateral ESP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
arm group label: control group
arm group type: Placebo Comparator
description: Bilateral ESP block with placebo to bupivacaine bilaterally plus placebo to dexamethasone
intervention type: Drug
intervention name: bupivacaine
description: Bilateral TAP block with 20 ml of 0.25% bupivacaine
arm group label: bupivacaine and dexamethasone
arm group label: bupivacaine and placebo to dexamethasone
other name: Active Comparator
intervention type: Drug
intervention name: dexamethasone
description: Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
arm group label: bupivacaine and dexamethasone
other name: active comparator
intervention type: Drug
intervention name: placebo to dexamethasone
description: Bilateral TAP block with placebo to dexamethasone.
arm group label: bupivacaine and placebo to dexamethasone
arm group label: control group
intervention type: Drug
intervention name: placebo to bupivacaine
description: Bilateral TAP block with placebo to bupivacaine.
arm group label: control group
criteria: 
gender: Female
gender based: Yes
gender description: patients undergoing total abdominal hysterectomy
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: hany f sallam, md
role: Principal Investigator
affiliation: Aswan University Hospital
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Aswan University Hospital
investigator full name: hany farouk
investigator title: Principal Investigator
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Bupivacaine
mesh term: BB 1101
sharing ipd: Undecided