<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/NCT03231215</url>
  </required_header>
  <id_info>
    <org_study_id>17100211</org_study_id>
    <nct_id>NCT03231215</nct_id>
  </id_info>
  <brief_title>The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery</brief_title>
  <official_title>The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement 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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy of dexamethasone when added to&#xD;
      epidural bupivacaine on the duration of postoperative analgesia in patients underwent total&#xD;
      knee replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty patients underwent total knee replacement were included in the study. The patients (11&#xD;
      male and 39 female) were classified into two equal groups:- The patients received 15 mL plain&#xD;
      bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups&#xD;
      was 17 ml.&#xD;
&#xD;
      Postoperative records:&#xD;
&#xD;
        1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.&#xD;
&#xD;
        2. Frequency of rescue analgesia.&#xD;
&#xD;
        3. Postoperative side effects like nausea, vomiting, and over sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of postoperative analgesia (NRS)</measure>
    <time_frame>24 hrs postoperative</time_frame>
    <description>first patient request for analgesia or NRS 4 or more</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>controlled group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexamethasone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>dexamethasone + plain Bupivacaine injected epidurally.</description>
    <arm_group_label>controlled group</arm_group_label>
    <arm_group_label>dexamethasone group</arm_group_label>
    <other_name>Decadrone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients scheduled for total knee replacement surgery.&#xD;
&#xD;
          2. ASA Physical status I,II,III.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Patients' refusal.&#xD;
&#xD;
          2. Uncooperative patients / Not able to understand pain assessment test.&#xD;
&#xD;
          3. Patients with history of allergy to the used drugs.&#xD;
&#xD;
          4. Significant liver disease.&#xD;
&#xD;
          5. Pregnancy.&#xD;
&#xD;
          6. Any contraindication for epidural anesthesia&#xD;
&#xD;
          7. Failed technique.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed galal aly</investigator_full_name>
    <investigator_title>Assistant Professor</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>Dexamethasone</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/NCT03231215
org study id: 17100211
nct id: NCT03231215
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study was to evaluate the efficacy of dexamethasone when added to
      epidural bupivacaine on the duration of postoperative analgesia in patients underwent total
      knee replacement surgery.
Fifty patients underwent total knee replacement were included in the study. The patients (11
      male and 39 female) were classified into two equal groups:- The patients received 15 mL plain
      bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups
      was 17 ml.

      Postoperative records:

        1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.

        2. Frequency of rescue analgesia.

        3. Postoperative side effects like nausea, vomiting, and over sedation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: duration of postoperative analgesia (NRS)
time frame: 24 hrs postoperative
description: first patient request for analgesia or NRS 4 or more
arm group label: controlled group
arm group type: Placebo Comparator
description: Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).
arm group label: dexamethasone group
arm group type: Active Comparator
description: Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)
intervention type: Drug
intervention name: Dexamethasone
description: dexamethasone + plain Bupivacaine injected epidurally.
arm group label: controlled group
arm group label: dexamethasone group
other name: Decadrone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed galal aly
investigator title: Assistant Professor
mesh term: Pain, Postoperative
mesh term: Dexamethasone