<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/NCT03767920</url>
  </required_header>
  <id_info>
    <org_study_id>aswu/180/7/18</org_study_id>
    <nct_id>NCT03767920</nct_id>
  </id_info>
  <brief_title>Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section</brief_title>
  <official_title>Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine&#xD;
      0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in&#xD;
      patients undergoing an elective Caesarean section.&#xD;
&#xD;
        -  Group 1: bupivacaine 0.25% + dexamethasone 8 mg&#xD;
&#xD;
        -  Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pain and discomfort following cesarean delivery are mostly due to the abdominal wall&#xD;
      incision and dissection of muscles; it delays early ambulation and breastfeeding. This can&#xD;
      lead to postoperative complications such as thromboembolic disorders. So, providing an&#xD;
      effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia&#xD;
      remains the most effective means of relieving pain in a wide variety of conditions; however,&#xD;
      it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and&#xD;
      respiratory depression. As the analgesia and the side effects of opioids are dose-dependent,&#xD;
      a multimodal approach may enhance analgesia, which in turn would decrease the side effects .&#xD;
&#xD;
      Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can&#xD;
      decrease the postoperative pain following abdominal surgery. The landmarks of this block were&#xD;
      first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic&#xD;
      control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under&#xD;
      spinal anesthesia, and laparoscopic surgery.&#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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analog score for pain during movement</measure>
    <time_frame>6 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 during rest</measure>
    <time_frame>48 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>48 hours postoperative</time_frame>
    <description>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>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>bupivacaine and dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bilateral TAP 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>BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <description>TAP block with 20 ml of 0.25% bupivacaine bilaterally</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>TAP block with 4 mg dexamethasone bilaterally</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>TAP block with 4 mg placebo to dexamethasone bilaterally</description>
    <arm_group_label>bupivacaine and placebo to dexamethasone</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants had known sensitivity to bupivacaine&#xD;
&#xD;
          -  patient refusal,&#xD;
&#xD;
          -  localized infection over injection point&#xD;
&#xD;
          -  patients with significant coagulopathies and&#xD;
&#xD;
          -  with contraindications to regional anesthesia,&#xD;
&#xD;
          -  patients with heart diseases, altered renal or liver functions,&#xD;
&#xD;
          -  psychological disorders, patients with pregnancy-induced hypertension and&#xD;
&#xD;
          -  gestational diabetes, chronic use of pain medications,&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>healthy parturient scheduled to undergo LSCS under spinal anesthesia</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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 7, 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>dexamethasone</keyword>
  <keyword>transversus abdominis plane block</keyword>
  <keyword>cesarean section</keyword>
  <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>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/NCT03767920
org study id: aswu/180/7/18
nct id: NCT03767920
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine
      0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in
      patients undergoing an elective Caesarean section.

        -  Group 1: bupivacaine 0.25% + dexamethasone 8 mg

        -  Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.
The pain and discomfort following cesarean delivery are mostly due to the abdominal wall
      incision and dissection of muscles; it delays early ambulation and breastfeeding. This can
      lead to postoperative complications such as thromboembolic disorders. So, providing an
      effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia
      remains the most effective means of relieving pain in a wide variety of conditions; however,
      it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and
      respiratory depression. As the analgesia and the side effects of opioids are dose-dependent,
      a multimodal approach may enhance analgesia, which in turn would decrease the side effects .

      Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can
      decrease the postoperative pain following abdominal surgery. The landmarks of this block were
      first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic
      control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under
      spinal anesthesia, and laparoscopic surgery.
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.
measure: Visual analog score for pain during movement
time frame: 6 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 during rest
time frame: 48 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: 48 hours postoperative
description: 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 TAP 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: BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone
intervention type: Drug
intervention name: bupivacaine
description: TAP block with 20 ml of 0.25% bupivacaine bilaterally
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: TAP block with 4 mg dexamethasone bilaterally
arm group label: bupivacaine and dexamethasone
other name: active comparator
intervention type: Drug
intervention name: placebo to dexamethasone
description: TAP block with 4 mg placebo to dexamethasone bilaterally
arm group label: bupivacaine and placebo to dexamethasone
other name: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: healthy parturient scheduled to undergo LSCS under spinal anesthesia
minimum age: 18 Years
maximum age: 45 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: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Bupivacaine
mesh term: BB 1101
sharing ipd: No