<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/NCT03230227</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00009912</org_study_id>
    <nct_id>NCT03230227</nct_id>
  </id_info>
  <brief_title>Presternal Magnesium With Bupivacain Versus Bupivacain Only for Postoperative Pain Relief in Open Heart Surgery</brief_title>
  <official_title>Presternal Local Analgesia for Postoperative Pain Relief After Open Heart 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>
      Effective pain relief after cardiac surgery has assumed importance with the introduction of&#xD;
      fast track discharge protocols that requires early weaning from mechanical ventilation.&#xD;
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of&#xD;
      atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound&#xD;
      has shown to improve early postoperative pain in various surgical procedures.&#xD;
&#xD;
      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in&#xD;
      animal and human models of pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Effective pain relief after cardiac surgery has assumed importance with the introduction of&#xD;
      fast track discharge protocols that requires early weaning from mechanical ventilation.&#xD;
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of&#xD;
      atelectasis, and prolongs recovery.&#xD;
&#xD;
      A major cause of pain after cardiac surgery is the median sternotomy particularly on the&#xD;
      first two postoperative days.&#xD;
&#xD;
      The most often used analgesics in these patients are parenteral opioids which can lead to&#xD;
      undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.&#xD;
&#xD;
      Infiltration of local anesthetics near the surgical wound has shown to improve early&#xD;
      postoperative pain in various surgical procedures.&#xD;
&#xD;
      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in&#xD;
      animal and human models of pain.&#xD;
&#xD;
      It has been mentioned in a systematic review that it may be worthwhile to further study the&#xD;
      role of supplemental magnesium in providing perioperative analgesia, because this is a&#xD;
      relatively harmless molecule, is not expensive and also because the biological basis for its&#xD;
      potential antinociceptive effect is promising.&#xD;
&#xD;
      These effects are primarily based on physiological calcium antagonism, that is&#xD;
      voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism&#xD;
      of N-methyl-D-aspartate (NMDA) receptors.&#xD;
&#xD;
      there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to&#xD;
      bupivacain&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>post open heart surgery pain alleviation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>2 days</time_frame>
    <description>assessing VAS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemodynamics</measure>
    <time_frame>24 hours</time_frame>
    <description>mean arterial blood pressure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine magnesium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bupivacain only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine 0.125% infusion in the presternum , for 48 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine magnesium</intervention_name>
    <description>bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours</description>
    <arm_group_label>Bupivacaine magnesium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine only</intervention_name>
    <description>bupivacaine 0.125% infusion in the presternum , for 48 hours</description>
    <arm_group_label>bupivacain only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-60 years old&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status II and III&#xD;
&#xD;
          -  Patients scheduled for open heart surgery with sternotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Emergency surgery&#xD;
&#xD;
          -  Clinically significant kidney or liver disease&#xD;
&#xD;
          -  Patients allergic to local anesthetic&#xD;
&#xD;
          -  Patients with prolonged CPB time (&gt;120 min)&#xD;
&#xD;
          -  Patients required intra-aortic balloon pump&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Emad Zarief Kamel Said</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Emad Zarief , MD</investigator_full_name>
    <investigator_title>lecturer 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>Bupivacaine</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/NCT03230227
org study id: IRB00009912
nct id: NCT03230227
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effective pain relief after cardiac surgery has assumed importance with the introduction of
      fast track discharge protocols that requires early weaning from mechanical ventilation.
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of
      atelectasis, and prolongs recovery. Infiltration of local anesthetics near the surgical wound
      has shown to improve early postoperative pain in various surgical procedures.

      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in
      animal and human models of pain.
Effective pain relief after cardiac surgery has assumed importance with the introduction of
      fast track discharge protocols that requires early weaning from mechanical ventilation.
      Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of
      atelectasis, and prolongs recovery.

      A major cause of pain after cardiac surgery is the median sternotomy particularly on the
      first two postoperative days.

      The most often used analgesics in these patients are parenteral opioids which can lead to
      undesirable side-effects as sedation, respiratory depression, nausea, and vomiting.

      Infiltration of local anesthetics near the surgical wound has shown to improve early
      postoperative pain in various surgical procedures.

      Magnesium is the fourth most plentiful cation in our body. It has antinociceptive effects in
      animal and human models of pain.

      It has been mentioned in a systematic review that it may be worthwhile to further study the
      role of supplemental magnesium in providing perioperative analgesia, because this is a
      relatively harmless molecule, is not expensive and also because the biological basis for its
      potential antinociceptive effect is promising.

      These effects are primarily based on physiological calcium antagonism, that is
      voltage-dependent regulation of calcium influx into the cell, and noncompetitive antagonism
      of N-methyl-D-aspartate (NMDA) receptors.

      there is a need to evaluate and compare local magnesium with bupivacaine , in comparison to
      bupivacain
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: post open heart surgery pain alleviation
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: postoperative pain
time frame: 2 days
description: assessing VAS scale
measure: hemodynamics
time frame: 24 hours
description: mean arterial blood pressure
arm group label: Bupivacaine magnesium
arm group type: Active Comparator
description: ( bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
arm group label: bupivacain only
arm group type: Active Comparator
description: bupivacaine 0.125% infusion in the presternum , for 48 hours
intervention type: Drug
intervention name: Bupivacaine magnesium
description: bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
arm group label: Bupivacaine magnesium
intervention type: Drug
intervention name: Bupivacaine only
description: bupivacaine 0.125% infusion in the presternum , for 48 hours
arm group label: bupivacain only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Emad Zarief , MD
investigator title: lecturer of anesthesia and ICU
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: Undecided