<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/NCT03786562</url>
  </required_header>
  <id_info>
    <org_study_id>01003060501</org_study_id>
    <nct_id>NCT03786562</nct_id>
  </id_info>
  <brief_title>The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.</brief_title>
  <official_title>The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic 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>No</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>
      How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal&#xD;
      administration of morphine in abdominoplastic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 8, 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative nausea and vomiting</measure>
    <time_frame>24 hours</time_frame>
    <description>A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10)&#xD;
by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating).&#xD;
A verbal descriptive scale (VDS) was used to assess the severity of PONV .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain and puririts.</measure>
    <time_frame>24 hours</time_frame>
    <description>Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Abdominal Obesity</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nalbuphine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Morphine</intervention_name>
    <description>Group 1</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal Morphine + Intravenous Nalbuphine</intervention_name>
    <description>Group 2</description>
    <arm_group_label>Nalbuphine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing abdominoplasty under spinal anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class I and II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to local anesthetics&#xD;
&#xD;
          -  bleeding diatheses&#xD;
&#xD;
          -  local infection or sepsis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female undergoing abdominoplasty</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Bakri, Prof</last_name>
    <phone>+20882413201</phone>
    <email>mhbakri@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eman Ismail, A professor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>March 13, 2020</last_update_submitted>
  <last_update_submitted_qc>March 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Eman A. Ismail</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Nalbuphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03786562
org study id: 01003060501
nct id: NCT03786562
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal
      administration of morphine in abdominoplastic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative nausea and vomiting
time frame: 24 hours
description: A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10)
by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating).
A verbal descriptive scale (VDS) was used to assess the severity of PONV .
measure: postoperative pain and puririts.
time frame: 24 hours
description: Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10).
arm group label: Placebo group
arm group type: Placebo Comparator
arm group label: Nalbuphine group
arm group type: Active Comparator
intervention type: Drug
intervention name: Intrathecal Morphine
description: Group 1
arm group label: Placebo group
intervention type: Drug
intervention name: Intrathecal Morphine + Intravenous Nalbuphine
description: Group 2
arm group label: Nalbuphine group
criteria: 
gender: Female
gender based: Yes
gender description: Female undergoing abdominoplasty
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Mohamed Bakri, Prof
phone: +20882413201
email: mhbakri@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Eman A. Ismail
investigator title: Clinical Professor
mesh term: Obesity, Abdominal
mesh term: Morphine
mesh term: Nalbuphine