<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/NCT03276325</url>
  </required_header>
  <id_info>
    <org_study_id>R/17.04.127</org_study_id>
    <nct_id>NCT03276325</nct_id>
  </id_info>
  <brief_title>Epidural Steroids With Intrathecal Nalbuphine for Lower Abdominal Oncologic Surgery</brief_title>
  <official_title>Epidural Steroids Combined With Intrathecal Nalbuphine: Analgesic and Side Effects Concept in Lower Abdominal Surgical Oncology Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during&#xD;
      lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory&#xD;
      block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine &amp;&#xD;
      IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8&#xD;
      mg nalbuphine compared with (IT) 0.4 mg nalbuphine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best&#xD;
      intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg&#xD;
      with the addition of epidural dexamethasone could augment the postoperative analgesia and&#xD;
      reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably&#xD;
      more effective than lower doses to control moderate to severe post-operative pain.&#xD;
      Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated&#xD;
      blood glucose level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">January 7, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Other</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Pain visual analog score (0: no pain, 100: worst imaginable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomiting</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>(0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory recovery</measure>
    <time_frame>For 5 hours after induction of anaesthesia</time_frame>
    <description>Regression to S1 spinal segment as tested with cold sensation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor recovery</measure>
    <time_frame>For 5 hours after induction of anaesthesia</time_frame>
    <description>The time until decreased a modified Bromage score of 0 (i.e. full leg movement)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First analgesic request</measure>
    <time_frame>For 12 hours after induction of anaesthesia</time_frame>
    <description>Time to first request of rescue analgesic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative heart rate changes</measure>
    <time_frame>For 3 hours after induction of anaesthesia</time_frame>
    <description>Changes in heart rate during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative mean arterial blood pressure changes</measure>
    <time_frame>For 3 hours after induction of anaesthesia</time_frame>
    <description>Changes in mean arterial blood pressure during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative heart rate changes</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Changes in heart rate after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mean arterial blood pressure changes</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Changes in mean arterial blood pressure after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative use of antiemetic</measure>
    <time_frame>for 24 hrs after surgery</time_frame>
    <description>Cumulative use of metoclopramide and ondansetron after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative use of rescue intravenous ketorolac</measure>
    <time_frame>for 24 hrs after surgery</time_frame>
    <description>Rescue use of ketorolac in case of severe pain conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative use of rescue intravenous nalbuphine</measure>
    <time_frame>For 24 hours after surgery</time_frame>
    <description>Rescue use of nalbuphine in case of severe pain conditions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Lower Abdominal Oncologic Surgery</condition>
  <arm_group>
    <arm_group_label>Placebo-nalbuphine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexamethasone-nalbuphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-nalbuphine</intervention_name>
    <description>Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%</description>
    <arm_group_label>Placebo-nalbuphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone-nalbuphine</intervention_name>
    <description>Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%</description>
    <arm_group_label>Dexamethasone-nalbuphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical class I or II.&#xD;
&#xD;
          -  Undergoing laparotomy&#xD;
&#xD;
          -  Undergoing oophorectomy&#xD;
&#xD;
          -  Undergoing hysterectomy&#xD;
&#xD;
          -  Undergoing rectal mass excision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Hypersensitivity to amide local anesthetics.&#xD;
&#xD;
          -  General contraindications to spinal anesthesia.&#xD;
&#xD;
          -  Cardiac diseases.&#xD;
&#xD;
          -  Hepatic failure.&#xD;
&#xD;
          -  Renal failure.&#xD;
&#xD;
          -  Respiratory failure.&#xD;
&#xD;
          -  Communication barriers.&#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>Mohamed A Ghanem, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistant Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University, Faculty of Medicine</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 7, 2018</last_update_submitted>
  <last_update_submitted_qc>January 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Nalbuphine</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/NCT03276325
org study id: R/17.04.127
nct id: NCT03276325
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Intraoperative pain, nausea, vomiting, hypotension, bradycardia are known side effects during
      lower abdominal surgery under spinal anesthesia, Time to 2 segment regression of sensory
      block and duration of effective analgesia prolonged with intrathecal (IT) 0.4 mg nalbuphine &
      IT 0.8 mg nalbuphine, but the incidence of side-effects was significantly higher with IT 0.8
      mg nalbuphine compared with (IT) 0.4 mg nalbuphine.
So, the hypothesis of using IT nalbuphine mid away dose 0.6 mg between the best
      intraoperative analgesic effective dose 0.8 mg and the least side effect producing dose 0.4mg
      with the addition of epidural dexamethasone could augment the postoperative analgesia and
      reduce the unwanted side effects. Epidural dexamethasone in a full dose of 8 mg is probably
      more effective than lower doses to control moderate to severe post-operative pain.
      Dexamethasone 8mg dose is surgically safe neither produced delayed wound healing nor elevated
      blood glucose level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Care Provider, Outcomes Assessor)
masking description: Double blind
measure: Pain score
time frame: For 24 hours after surgery
description: Pain visual analog score (0: no pain, 100: worst imaginable pain)
measure: Nausea and vomiting
time frame: For 24 hours after surgery
description: (0: no nausea, 1: nausea, 2: mild vomiting, 3: moderate vomiting, 4: severe vomiting)
measure: Sensory recovery
time frame: For 5 hours after induction of anaesthesia
description: Regression to S1 spinal segment as tested with cold sensation
measure: Motor recovery
time frame: For 5 hours after induction of anaesthesia
description: The time until decreased a modified Bromage score of 0 (i.e. full leg movement)
measure: First analgesic request
time frame: For 12 hours after induction of anaesthesia
description: Time to first request of rescue analgesic
measure: Intraoperative heart rate changes
time frame: For 3 hours after induction of anaesthesia
description: Changes in heart rate during surgery
measure: Intraoperative mean arterial blood pressure changes
time frame: For 3 hours after induction of anaesthesia
description: Changes in mean arterial blood pressure during surgery
measure: Postoperative heart rate changes
time frame: For 24 hours after surgery
description: Changes in heart rate after surgery
measure: Postoperative mean arterial blood pressure changes
time frame: For 24 hours after surgery
description: Changes in mean arterial blood pressure after surgery
measure: Cumulative use of antiemetic
time frame: for 24 hrs after surgery
description: Cumulative use of metoclopramide and ondansetron after surgery
measure: Cumulative use of rescue intravenous ketorolac
time frame: for 24 hrs after surgery
description: Rescue use of ketorolac in case of severe pain conditions
measure: Cumulative use of rescue intravenous nalbuphine
time frame: For 24 hours after surgery
description: Rescue use of nalbuphine in case of severe pain conditions
arm group label: Placebo-nalbuphine
arm group type: Placebo Comparator
description: Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
arm group label: Dexamethasone-nalbuphine
arm group type: Active Comparator
description: Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
intervention type: Drug
intervention name: Placebo-nalbuphine
description: Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
arm group label: Placebo-nalbuphine
intervention type: Drug
intervention name: Dexamethasone-nalbuphine
description: Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
arm group label: Dexamethasone-nalbuphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mohamed A Ghanem, MD
role: Study Chair
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Dexamethasone
mesh term: Nalbuphine
sharing ipd: Undecided