<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/NCT04442906</url>
  </required_header>
  <id_info>
    <org_study_id>5355</org_study_id>
    <nct_id>NCT04442906</nct_id>
  </id_info>
  <brief_title>Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl</brief_title>
  <official_title>Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig 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>
      The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus&#xD;
      Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided&#xD;
      into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml&#xD;
      bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml&#xD;
      bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).&#xD;
&#xD;
      Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).&#xD;
      The time of first request of analgesia and analgesic effect by VAS during the first 24 hr.&#xD;
      postoperatively are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">November 1, 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>
    <intervention_model_description>analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>anesthetist not sharing in the study will assess patient</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of postoperative analgesia</measure>
    <time_frame>For 24 hours postoperative</time_frame>
    <description>start from intra-articular injection of the drug to the time of first request of analgesia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total dose of rescue analgesia ( pethidine)</measure>
    <time_frame>within 24 hours postoperative</time_frame>
    <description>total consumption of rescue analgesia (pethidine) postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of participants with bradycardia, itching and hypotension</measure>
    <time_frame>Within 24 hours postoperative</time_frame>
    <description>The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>within 24 hours postoperative</time_frame>
    <description>Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>measured immediately preoperative 0 minute ( admission receiving area)</time_frame>
    <description>measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 30 minutes postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 1 hour postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 2 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 4 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 6 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 8 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 12 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 18 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity at rest (static)</measure>
    <time_frame>at 24 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>measured immediately preoperative 0 minute ( admission receiving area)</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 30 minutes postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 1 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 2 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 4 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 6 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 8 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 12 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 18 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity on mobilization of operated knee (dynamic)</measure>
    <time_frame>at 24 hours postoperative</time_frame>
    <description>measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group BD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group BF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).</description>
    <arm_group_label>group BD</arm_group_label>
    <other_name>precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)</description>
    <arm_group_label>group BF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacain</intervention_name>
    <description>Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.</description>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group BD</arm_group_label>
    <arm_group_label>group BF</arm_group_label>
    <other_name>marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Either sex,&#xD;
&#xD;
          -  Age 21-45 years,&#xD;
&#xD;
          -  American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients with history of hepatic and renal diseases, psychiatric disorders,&#xD;
&#xD;
          -  Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),&#xD;
&#xD;
          -  Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery&#xD;
             were excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina Salem, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>faculty of medicine , Zagazig University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zagazig university</name>
      <address>
        <city>Zagazig</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 20, 2021</last_update_submitted>
  <last_update_submitted_qc>January 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Dina Abdelhameed Elsadek Salem</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>dexmedetomidine</keyword>
  <keyword>fentanyl</keyword>
  <keyword>bupivacaine</keyword>
  <keyword>knee arthroscopy</keyword>
  <keyword>postoperative analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</mesh_term>
    <mesh_term>Bupivacaine</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/NCT04442906
org study id: 5355
nct id: NCT04442906
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus
      Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic
      surgery.
Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided
      into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml
      bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml
      bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).

      Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
      The time of first request of analgesia and analgesic effect by VAS during the first 24 hr.
      postoperatively are recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: anesthetist not sharing in the study will assess patient
measure: Duration of postoperative analgesia
time frame: For 24 hours postoperative
description: start from intra-articular injection of the drug to the time of first request of analgesia
measure: total dose of rescue analgesia ( pethidine)
time frame: within 24 hours postoperative
description: total consumption of rescue analgesia (pethidine) postoperative
measure: The number of participants with bradycardia, itching and hypotension
time frame: Within 24 hours postoperative
description: The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )
measure: patient satisfaction
time frame: within 24 hours postoperative
description: Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)
measure: pain intensity at rest (static)
time frame: measured immediately preoperative 0 minute ( admission receiving area)
description: measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 30 minutes postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 1 hour postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 2 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 4 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 6 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 8 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 12 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 18 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity at rest (static)
time frame: at 24 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: measured immediately preoperative 0 minute ( admission receiving area)
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 30 minutes postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 1 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 2 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 4 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 6 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 8 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 12 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 18 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
measure: pain intensity on mobilization of operated knee (dynamic)
time frame: at 24 hours postoperative
description: measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)
arm group label: group B
arm group type: Active Comparator
description: IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline
arm group label: group BD
arm group type: Active Comparator
description: . Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
arm group label: group BF
arm group type: Active Comparator
description: Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).
intervention type: Drug
intervention name: Dexmedetomidine
description: Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
arm group label: group BD
other name: precedex
intervention type: Drug
intervention name: Fentanyl
description: Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)
arm group label: group BF
intervention type: Drug
intervention name: Bupivacain
description: Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
arm group label: group B
arm group label: group BD
arm group label: group BF
other name: marcaine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dina Salem, MD.
role: Principal Investigator
affiliation: faculty of medicine , Zagazig University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Dina Abdelhameed Elsadek Salem
investigator title: Principle investigator
mesh term: Agnosia
mesh term: Fentanyl
mesh term: Dexmedetomidine
mesh term: Bupivacaine