<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/NCT03785041</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH7923/16</org_study_id>
    <nct_id>NCT03785041</nct_id>
  </id_info>
  <brief_title>Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol</brief_title>
  <official_title>Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol</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>
      Comparison between preemptive and postoperative intraarticular injection of tramadol on pain&#xD;
      sensation after arthroscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in&#xD;
      this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine&#xD;
      alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or&#xD;
      divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25&#xD;
      % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain&#xD;
      sensation. Duration till request of rescue analgesia and number of requests were recorded.&#xD;
      Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa&#xD;
      Satisfaction with Anesthesia Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2016</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain control</measure>
    <time_frame>Pain assessment for 12 hours postoperative</time_frame>
    <description>Pain sensation after arthroscopy assessed by numeric rating scale depending upon patient facial appearance with severe patient expressing high score and no pain with lowest score</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Pain After Knee Arthroscop</condition>
  <arm_group>
    <arm_group_label>Levobupivacaine and tramadol Preemptive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tramadol and levobupivacaine postoperative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tramadol and levobupivacaine preemptive and postoperative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levobupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine Hydrochloride 2.5 MG/ML</intervention_name>
    <description>Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative</description>
    <arm_group_label>Levobupivacaine</arm_group_label>
    <arm_group_label>Levobupivacaine and tramadol Preemptive</arm_group_label>
    <arm_group_label>Tramadol and levobupivacaine postoperative</arm_group_label>
    <arm_group_label>Tramadol and levobupivacaine preemptive and postoperative</arm_group_label>
    <other_name>Tramadol 50 MG/ML</other_name>
    <other_name>Tramadol 100 MG/ML</other_name>
    <other_name>Levobupivacaine Hydrochloride 5MG/ML</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient physical status according to American Society of Anesthesiology (ASA) classes&#xD;
             I-II&#xD;
&#xD;
          -  Patients free of general diseases prohibiting the use of local anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients had allergy for local anesthetics or to tramadol&#xD;
&#xD;
          -  Patients have psychological or neurological disorders inducing difficulty for&#xD;
             evaluation of pain scoring.&#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>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 24, 2018</last_update_submitted>
  <last_update_submitted_qc>December 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Tramadol</keyword>
  <keyword>Intra-articular injection</keyword>
  <keyword>Preemptive</keyword>
  <keyword>post-arthroscopy pain</keyword>
  <keyword>Levobupivacaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
    <mesh_term>Levobupivacaine</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/NCT03785041
org study id: ASUH7923/16
nct id: NCT03785041
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison between preemptive and postoperative intraarticular injection of tramadol on pain
      sensation after arthroscopy
220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in
      this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine
      alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or
      divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25
      % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain
      sensation. Duration till request of rescue analgesia and number of requests were recorded.
      Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa
      Satisfaction with Anesthesia Scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pain control
time frame: Pain assessment for 12 hours postoperative
description: Pain sensation after arthroscopy assessed by numeric rating scale depending upon patient facial appearance with severe patient expressing high score and no pain with lowest score
arm group label: Levobupivacaine and tramadol Preemptive
arm group type: Active Comparator
description: 20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
arm group label: Tramadol and levobupivacaine postoperative
arm group type: Active Comparator
description: 20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.
arm group label: Tramadol and levobupivacaine preemptive and postoperative
arm group type: Active Comparator
description: 20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.
arm group label: Levobupivacaine
arm group type: Active Comparator
description: 20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.
intervention type: Drug
intervention name: Levobupivacaine Hydrochloride 2.5 MG/ML
description: Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative
arm group label: Levobupivacaine
arm group label: Levobupivacaine and tramadol Preemptive
arm group label: Tramadol and levobupivacaine postoperative
arm group label: Tramadol and levobupivacaine preemptive and postoperative
other name: Tramadol 50 MG/ML
other name: Tramadol 100 MG/ML
other name: Levobupivacaine Hydrochloride 5MG/ML
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Tramadol
mesh term: Levobupivacaine
sharing ipd: No