<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/NCT04433624</url>
  </required_header>
  <id_info>
    <org_study_id>FMBSUREC/07062020/Abd El Badei</org_study_id>
    <nct_id>NCT04433624</nct_id>
  </id_info>
  <brief_title>Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery</brief_title>
  <official_title>Analgesic Efficacy of the Erector Spinae Plane Block Using Bupivacaine Versus Bupivacaine/Magnesium Sulphate in Patients Undergoing Lumbar Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beni-Suef University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beni-Suef University</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>
      Introduction:&#xD;
&#xD;
      Severe postoperative pain following spine surgery is a significant cause of morbidity,&#xD;
      extended length of facility stay, and marked opioid usage&#xD;
&#xD;
      The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids.&#xD;
      The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression,&#xD;
      constipation, delayed patient mobilization) has led perioperative physicians to find a way of&#xD;
      decreasing the use of opioids. Increasing the use of regional anesthesia is one of the&#xD;
      measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular,&#xD;
      interfascial regional technique that was initially described for the management of thoracic&#xD;
      neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to&#xD;
      the sacrum caudally, local anesthetic agents extend through several levels, and the block can&#xD;
      be effective over a large area The ESP block provides effective postoperative analgesic&#xD;
      effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a&#xD;
      noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect&#xD;
      and is essential for release of acetylcholine from the presynaptic terminals and, similar to&#xD;
      calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is&#xD;
      suggested that magnesium has many important roles to play in nociception&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using&#xD;
      bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      orthopedic and neurological patients undergoing posterior lumbar spine fusion [American&#xD;
      Society of Anesthesiologists (ASA) physical status 1 or 2.&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        1. -Contraindications for regional blocks (eg. Patient refusal Infection at the injection&#xD;
           site, coagulopathy)&#xD;
&#xD;
        2. allergic reaction to drugs.&#xD;
&#xD;
        3. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction&#xD;
           disturbance.&#xD;
&#xD;
        4. opium addiction, any drug or substance abuse and chronic treatment with opium,&#xD;
           non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).&#xD;
&#xD;
      The patients will be blinded to the study drugs and will be randomly assigned into two equal&#xD;
      groups by opaque sealed envelope as follows:&#xD;
&#xD;
      Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of&#xD;
      0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of&#xD;
      the erector spinae muscle and the transverse processes of the lumbar vertebrae&#xD;
&#xD;
      Group B MG (n=15): will receive bilateral ESP blocks performed by each side) and and 500 mg&#xD;
      magnesium sulphate into the fascial plane between the deep surface of the erector spinae&#xD;
      muscle and the transverse processes of the lumbar vertebrae for pain management after lumbar&#xD;
      spinal surgery injecting 40 mL of 0.25% bupivacaine(20 mL into each side)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 18, 2020</start_date>
  <completion_date type="Anticipated">December 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 10, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time to first request of analgesics in hours</measure>
    <time_frame>change from base line for 24 hours</time_frame>
    <description>time to first request of analgesics by the pateint in hours</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Group (B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive The bilateral ESP blocks before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B MG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>will receive bilateral ESP blocks performed by each side) before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group (B)</intervention_name>
    <description>Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae</description>
    <arm_group_label>Group (B)</arm_group_label>
    <arm_group_label>Group B MG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  orthopedic&#xD;
&#xD;
          -  neurological patients&#xD;
&#xD;
          -  undergoing posterior lumbar spine fusion&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status 1 or 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for regional blocks&#xD;
&#xD;
          -  allergic reaction to drugs.&#xD;
&#xD;
          -  Patients with a history of liver, renal, heart and vascular failure, cardiac&#xD;
             conduction disturbance.&#xD;
&#xD;
          -  opium addiction, any drug or substance abuse and chronic treatment with opium,&#xD;
             non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>doaa rashwan, md</last_name>
    <phone>00201011270763</phone>
    <email>doaa_rashwan@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Banī Suwayf, Egypt, 11391</name>
      <address>
        <city>Banī Suwayf</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doaa Rashwan, MD</last_name>
      <phone>01011270763</phone>
      <email>doaa_rashwan@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beni-Suef University</investigator_affiliation>
    <investigator_full_name>doaa rashwan</investigator_full_name>
    <investigator_title>Assistant professor Doaa Rashwan</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>
  <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/NCT04433624
org study id: FMBSUREC/07062020/Abd El Badei
nct id: NCT04433624
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Severe postoperative pain following spine surgery is a significant cause of morbidity,
      extended length of facility stay, and marked opioid usage

      The analgesic regime for postoperative pain usually includes paracetamol,NSAIDs and opioids.
      The opioid epidemic as well as the opioid side effects2 (sedation,respiratory depression,
      constipation, delayed patient mobilization) has led perioperative physicians to find a way of
      decreasing the use of opioids. Increasing the use of regional anesthesia is one of the
      measures to this end. Ultrasound-guided erector spinae plane block (ESP) is a-- popular,
      interfascial regional technique that was initially described for the management of thoracic
      neuropathic pain . As the erector spinae fascia extends from the nuchal fascia cranially to
      the sacrum caudally, local anesthetic agents extend through several levels, and the block can
      be effective over a large area The ESP block provides effective postoperative analgesic
      effect for 24 hours in patients undergoing lumbar spinal surgery Magnesium sulfate (MGS) is a
      noncompetitive antagonist of N-methyl, D-aspartate (NMDA) receptors with an analgesic effect
      and is essential for release of acetylcholine from the presynaptic terminals and, similar to
      calcium channel blockers (CCB), can prevent the entry of calcium into the cell It is
      suggested that magnesium has many important roles to play in nociception
The aim of this study is to evaluate the efficacy of the Erector Spinae Plane Block using
      bupivacaine versus bupivacaine/magnesium sulphate in Patients Undergoing Lumbar Spine surgery

      Inclusion criteria:

      orthopedic and neurological patients undergoing posterior lumbar spine fusion [American
      Society of Anesthesiologists (ASA) physical status 1 or 2.

      Exclusion Criteria:

        1. -Contraindications for regional blocks (eg. Patient refusal Infection at the injection
           site, coagulopathy)

        2. allergic reaction to drugs.

        3. Patients with a history of liver, renal, heart and vascular failure, cardiac conduction
           disturbance.

        4. opium addiction, any drug or substance abuse and chronic treatment with opium,
           non-steroidal anti-inflammatory drugs and calcium channel blockers (CCB).

      The patients will be blinded to the study drugs and will be randomly assigned into two equal
      groups by opaque sealed envelope as follows:

      Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of
      0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of
      the erector spinae muscle and the transverse processes of the lumbar vertebrae

      Group B MG (n=15): will receive bilateral ESP blocks performed by each side) and and 500 mg
      magnesium sulphate into the fascial plane between the deep surface of the erector spinae
      muscle and the transverse processes of the lumbar vertebrae for pain management after lumbar
      spinal surgery injecting 40 mL of 0.25% bupivacaine(20 mL into each side)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: time to first request of analgesics in hours
time frame: change from base line for 24 hours
description: time to first request of analgesics by the pateint in hours
arm group label: Group (B)
arm group type: Active Comparator
description: will receive The bilateral ESP blocks before surgery
arm group label: Group B MG
arm group type: Active Comparator
description: will receive bilateral ESP blocks performed by each side) before surgery
intervention type: Other
intervention name: Group (B)
description: Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
arm group label: Group (B)
arm group label: Group B MG
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: doaa rashwan, md
phone: 00201011270763
email: doaa_rashwan@hotmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Beni-Suef University
investigator full name: doaa rashwan
investigator title: Assistant professor Doaa Rashwan
mesh term: Pain, Postoperative
sharing ipd: Undecided