<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/NCT02247648</url>
  </required_header>
  <id_info>
    <org_study_id>unique Protocol ID</org_study_id>
    <nct_id>NCT02247648</nct_id>
  </id_info>
  <brief_title>Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy</brief_title>
  <official_title>Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre hospitalier de l'Université de Montréal (CHUM)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre hospitalier de l'Université de Montréal (CHUM)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that the use of tramadol will reduce pain and analgesic&#xD;
      consumption after arthroscopic shoulder surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study was to evaluate the efficacy of tramadol long acting for post&#xD;
      operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in&#xD;
      comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as&#xD;
      the quantity of hydromorphone taken by patients, and the side effects during the first 72&#xD;
      hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date type="Actual">June 2013</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quantity of hydromorphone consumed</measure>
    <time_frame>3 days</time_frame>
    <description>determination of the quantity of hydromorphone consumed at different laps</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of pain (The intensity of pain was evaluated on a visual analog scale)</measure>
    <time_frame>3 days</time_frame>
    <description>evaluation of the pain at different laps</description>
  </secondary_outcome>
  <other_outcome>
    <measure>nausea</measure>
    <time_frame>3 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>dizziness</measure>
    <time_frame>3 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>pruritus</measure>
    <time_frame>3 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Pain</condition>
  <condition>Vertigo</condition>
  <condition>Nausea</condition>
  <condition>Pruritus</condition>
  <arm_group>
    <arm_group_label>treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment: tramadol group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>control: placebo group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tramadol</intervention_name>
    <description>Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3</description>
    <arm_group_label>treatment</arm_group_label>
    <other_name>tridural</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients from control group received a &quot;shame&quot; tramadol pill on day one, two, and 3</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged more than 18 year old&#xD;
&#xD;
          -  arthroscopic shoulder surgery on interscalen block&#xD;
&#xD;
          -  able to understand the protocol&#xD;
&#xD;
          -  inform consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic pain or chronic used of narcotics&#xD;
&#xD;
          -  Use of IMAO&#xD;
&#xD;
          -  Use of ISRS&#xD;
&#xD;
          -  Pulmonary chronic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Denis Roy, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of the Anesthesia Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de chirurgie spécialisée de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>h3s 2w1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tramadol</keyword>
  <keyword>shoulder surgery</keyword>
  <keyword>pain</keyword>
  <keyword>interscalen block</keyword>
  <keyword>BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vertigo</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</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/NCT02247648
org study id: unique Protocol ID
nct id: NCT02247648
lead sponsor: 
has dmc: Yes
The investigators hypothesize that the use of tramadol will reduce pain and analgesic
      consumption after arthroscopic shoulder surgery.
The purpose of the study was to evaluate the efficacy of tramadol long acting for post
      operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in
      comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as
      the quantity of hydromorphone taken by patients, and the side effects during the first 72
      hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: quantity of hydromorphone consumed
time frame: 3 days
description: determination of the quantity of hydromorphone consumed at different laps
measure: evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
time frame: 3 days
description: evaluation of the pain at different laps
measure: nausea
time frame: 3 days
measure: dizziness
time frame: 3 days
measure: pruritus
time frame: 3 days
arm group label: treatment
arm group type: Experimental
description: treatment: tramadol group
arm group label: control
arm group type: Placebo Comparator
description: control: placebo group
intervention type: Drug
intervention name: tramadol
description: Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
arm group label: treatment
other name: tridural
intervention type: Drug
intervention name: Placebo
description: Patients from control group received a "shame" tramadol pill on day one, two, and 3
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Denis Roy, Doctor
role: Principal Investigator
affiliation: Head of the Anesthesia Department
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Vertigo
mesh term: Pruritus
mesh term: Tramadol