<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/NCT03018301</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0000871238</org_study_id>
    <nct_id>NCT03018301</nct_id>
  </id_info>
  <brief_title>Intravenous Ketamine and Postoperative Pain Following Cesarean Section.</brief_title>
  <official_title>Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the analgesic effect of low-dose intravenous&#xD;
      ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  No premedication will be given, and patients will be monitored by electrocardiogram,&#xD;
           non-invasive arterial blood pressure, and pulse oximetry when they entered the operating&#xD;
           room.&#xD;
&#xD;
        -  18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of&#xD;
           lactate ringer over 20 min period.&#xD;
&#xD;
        -  All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as&#xD;
           well as the method of injection will be identical for all individuals; 10 mg (2 cc&#xD;
           0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting&#xD;
           position.&#xD;
&#xD;
        -  After administering bupivacaine, and prior to surgery the height of the sensory block&#xD;
           will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion&#xD;
           starting from T12 dermatome.&#xD;
&#xD;
        -  Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will&#xD;
           be allowed to begin. When systolic blood pressure decrease to &lt; 90 mmHg, or 30% of the&#xD;
           pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.&#xD;
&#xD;
        -  Patients will be asked to report any intraoperative pain using visual pain score(VPS)of&#xD;
           0(no pain) 10(worst pain).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 2</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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• Number of Subjects Requiring Supplemental Analgesia</measure>
    <time_frame>24 hours postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative morphine/paracetamol</measure>
    <time_frame>24 hours postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects reporting nausea, vomiting</measure>
    <time_frame>24 hours postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Ketamine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>will receive intravenous 20 ml of normal saline, delivered over 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.</description>
    <arm_group_label>Ketamine group</arm_group_label>
    <other_name>Ketalar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>will receive intravenous 20 ml of normal saline, delivered over 10 minutes.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for&#xD;
             elective cesarean section whose anesthetic plan is for spinal anesthesia with&#xD;
             Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Body mass index ≥40 kg/m2,&#xD;
&#xD;
               -  Known allergy to any of the study medications,&#xD;
&#xD;
               -  Contraindication to the spinal anesthesia,&#xD;
&#xD;
               -  History of substance abuse,&#xD;
&#xD;
               -  History of hallucinations,&#xD;
&#xD;
               -  Chronic opioid therapy,&#xD;
&#xD;
               -  Chronic pain.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Israa M Sayed</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdelrady S Ibrahim, MD</last_name>
    <phone>00201026249924</phone>
    <email>aradys2004@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hamdy A Yousef, MD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut university faculty of medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abdelrady S Ibrahim, MD</last_name>
      <phone>00201026249924</phone>
      <email>aradys2004@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.</citation>
    <PMID>17459695</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdelrady S Ibrahim, MD</investigator_full_name>
    <investigator_title>Assistant professor of anesthesia and ICU</investigator_title>
  </responsible_party>
  <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>Ketamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03018301
org study id: IRB0000871238
nct id: NCT03018301
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the analgesic effect of low-dose intravenous
      ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.
-  No premedication will be given, and patients will be monitored by electrocardiogram,
           non-invasive arterial blood pressure, and pulse oximetry when they entered the operating
           room.

        -  18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of
           lactate ringer over 20 min period.

        -  All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as
           well as the method of injection will be identical for all individuals; 10 mg (2 cc
           0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting
           position.

        -  After administering bupivacaine, and prior to surgery the height of the sensory block
           will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion
           starting from T12 dermatome.

        -  Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will
           be allowed to begin. When systolic blood pressure decrease to < 90 mmHg, or 30% of the
           pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.

        -  Patients will be asked to report any intraoperative pain using visual pain score(VPS)of
           0(no pain) 10(worst pain).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: • Number of Subjects Requiring Supplemental Analgesia
time frame: 24 hours postoperative
measure: Cumulative morphine/paracetamol
time frame: 24 hours postoperative
measure: Number of subjects reporting nausea, vomiting
time frame: 24 hours postoperative
arm group label: Ketamine group
arm group type: Active Comparator
description: will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
arm group label: Control group
arm group type: Placebo Comparator
description: will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
intervention type: Drug
intervention name: Ketamine
description: will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
arm group label: Ketamine group
other name: Ketalar
intervention type: Other
intervention name: Normal saline
description: will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
arm group label: Control group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Israa M Sayed
role: Study Chair
affiliation: Assiut University
last name: Abdelrady S Ibrahim, MD
phone: 00201026249924
email: aradys2004@gmail.com
last name: Hamdy A Yousef, MD
facility: 
status: Recruiting
contact: 
country: Egypt
citation: El-Tahan MR, Warda OM, Yasseen AM, Attallah MM, Matter MK. A randomized study of the effects of preoperative ketorolac on general anaesthesia for caesarean section. Int J Obstet Anesth. 2007 Jul;16(3):214-20. doi: 10.1016/j.ijoa.2007.01.012. Epub 2007 Apr 24.
PMID: 17459695
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrady S Ibrahim, MD
investigator title: Assistant professor of anesthesia and ICU
mesh term: Pain, Postoperative
mesh term: Ketamine
sharing ipd: Yes