<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/NCT04411329</url>
  </required_header>
  <id_info>
    <org_study_id>R15/2020</org_study_id>
    <nct_id>NCT04411329</nct_id>
  </id_info>
  <brief_title>Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery</brief_title>
  <official_title>Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a&#xD;
      negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine&#xD;
      surgeries should be implemented to prevent CNS plasticity and to provide effective pain&#xD;
      relief.&#xD;
&#xD;
      The most common way to provide pain management after spine surgery is the intravenous&#xD;
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain&#xD;
      relief.&#xD;
&#xD;
      The most common way to provide pain management after spine surgery is the intravenous&#xD;
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain&#xD;
      relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid&#xD;
      adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine,&#xD;
      dexmedetomidine), or their combination. This study will compare adding different non opioid&#xD;
      adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine&#xD;
      surgery which can be a part of multimodal analgesia protocol.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patient will be enrolled in the study. They will be allocated randomly into 3 groups.&#xD;
      after induction of general anesthesia and changing the patient into prone position injection&#xD;
      of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of&#xD;
      the same mixture at the end of surgery) in all patients.&#xD;
&#xD;
      In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the&#xD;
      second group we will add 50µg dexmedetomidine to the previous mixture given to the first&#xD;
      group.&#xD;
&#xD;
      In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group&#xD;
&#xD;
      During the operation adjustment of sevoflurane concentration and fentanyl incremental doses&#xD;
      (0.5 μg/kg) will be according to hemodynamic measurements.&#xD;
&#xD;
      Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart&#xD;
      rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at&#xD;
      beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are&#xD;
      observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the&#xD;
      study.&#xD;
&#xD;
      In case of decrease in Blood Pressure greater than 20% from baseline, the patient will be&#xD;
      infused by 500 ml ringer lactate and if blood pressure is not responding, administration of&#xD;
      increments of 3 mg ephedrine will be given. Also If heart rate decreased to 45 beats/min,&#xD;
      atropine sulfate 0.01 mg/kg will be given. Muscle paralysis will be antagonized by sugmmadex&#xD;
      2mg/kg at the end of surgery after switching the patient to the supine position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Actual">May 6, 2021</completion_date>
  <primary_completion_date type="Actual">May 6, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The duration of analgesia</measure>
    <time_frame>postoerative 24 hours.</time_frame>
    <description>time from second dose caudal epidural block to first analgesic requirement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>VAS score from zero for (no pain) till 10 for ( the most severe intractable pain)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Caudal Analgesia for Lumosacral Spine Surgeries</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group c</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>local anesthetics, steriod, alpha 2 blockers</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group c</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>dexamethazone</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group c</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>dexmedetomidine</description>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyalouridinase</intervention_name>
    <description>hyalouridinase</description>
    <arm_group_label>group c</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are aged from 18-65 years , ASA I and II, scheduled for lumbar spine surgery&#xD;
             (laminectomy, discectomy, foraminotomy, fenestration or fusion) in a virgin back.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with multiple level fixation, revision surgery, complicated spinal canal&#xD;
             stenosis, traumatic lumbar surgeries were excluded, patients with addiction, allergy&#xD;
             to local anesthetics or to any drug used in the study and those with coagulation&#xD;
             abnormality are also excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sanaa Farag Mahmoud</name>
      <address>
        <city>Cairo</city>
        <state>New Cairo</state>
        <zip>11835</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ainshams hospitals</name>
      <address>
        <city>Cairo</city>
        <zip>11591</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.</citation>
    <PMID>23362890</PMID>
  </reference>
  <reference>
    <citation>Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.</citation>
    <PMID>20512512</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 16, 2021</last_update_submitted>
  <last_update_submitted_qc>May 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Sanaa Farag Mahmoud Wasfy</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04411329
org study id: R15/2020
nct id: NCT04411329
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lumbosacral spine surgeries are accompanied with severe postoperative pain which has a
      negative effect on patients' recovery. Preemptive analgesia before lumbosacral spine
      surgeries should be implemented to prevent CNS plasticity and to provide effective pain
      relief.

      The most common way to provide pain management after spine surgery is the intravenous
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain
      relief.

      The most common way to provide pain management after spine surgery is the intravenous
      analgesia. Caudal epidural analgesia can be a highly effective method for postoperative pain
      relief. acting drugs last from 4-8 hours,But this can be prolonged by adding non opioid
      adjuvants like steroid( dexamethazone,betamethasone), alpha2 agonists (clonidine,
      dexmedetomidine), or their combination. This study will compare adding different non opioid
      adjuvants to bupivacaine in caudal epidural for preventive analgesia in lumbosacral spine
      surgery which can be a part of multimodal analgesia protocol.

      .
60 patient will be enrolled in the study. They will be allocated randomly into 3 groups.
      after induction of general anesthesia and changing the patient into prone position injection
      of the study cocktail through caudal epidural route.(20 ml before skin incision and 10 ml of
      the same mixture at the end of surgery) in all patients.

      In the first group patients will receive 0.125% bupivacaine with 8 mg dexamethasone In the
      second group we will add 50µg dexmedetomidine to the previous mixture given to the first
      group.

      In the third group we will add 1500 IU hyalurodinase to the mixture given to the first group

      During the operation adjustment of sevoflurane concentration and fentanyl incremental doses
      (0.5 μg/kg) will be according to hemodynamic measurements.

      Clinical signs of inadequate analgesia is defined as an increase in blood pressure and heart
      rate more than 20% from baseline. Efficacy of the caudal epidural block will be tested at
      beginning of skin incision (15-20 minutes after block). If signs of inadequate analgesia are
      observed, fentanyl 0.5 µg/kg will be given and those patients will be excluded from the
      study.

      In case of decrease in Blood Pressure greater than 20% from baseline, the patient will be
      infused by 500 ml ringer lactate and if blood pressure is not responding, administration of
      increments of 3 mg ephedrine will be given. Also If heart rate decreased to 45 beats/min,
      atropine sulfate 0.01 mg/kg will be given. Muscle paralysis will be antagonized by sugmmadex
      2mg/kg at the end of surgery after switching the patient to the supine position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The duration of analgesia
time frame: postoerative 24 hours.
description: time from second dose caudal epidural block to first analgesic requirement
measure: postoperative pain
time frame: postoperative 24 hours
description: VAS score from zero for (no pain) till 10 for ( the most severe intractable pain)
arm group label: group A
arm group type: Active Comparator
description: patients will receive 30 ml of 0.125% bupivacaine with 8 mg dexamethasone (20 ml before skin incision and 10 ml at end of surgery
arm group label: group B
arm group type: Active Comparator
description: we will add 50µg dexmedetomidine to the previous mixture given to group A (20 ml before skin incision and 10 ml at end of surgery
arm group label: group c
arm group type: Active Comparator
description: we will add 1500 IU hyalurodinase to the mixture given to group A. (20 ml before skin incision and 10 ml at end of surgery
intervention type: Drug
intervention name: Bupivacaine
description: local anesthetics, steriod, alpha 2 blockers
arm group label: group A
arm group label: group B
arm group label: group c
intervention type: Drug
intervention name: Dexamethasone
description: dexamethazone
arm group label: group A
arm group label: group B
arm group label: group c
intervention type: Drug
intervention name: Dexmedetomidine
description: dexmedetomidine
arm group label: group B
intervention type: Drug
intervention name: Hyalouridinase
description: hyalouridinase
arm group label: group c
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Egypt
citation: Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.
PMID: 23362890
citation: Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.
PMID: 20512512
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Sanaa Farag Mahmoud Wasfy
investigator title: principal investigator
mesh term: Dexamethasone
mesh term: Dexmedetomidine
mesh term: Bupivacaine
sharing ipd: No