<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/NCT02238340</url>
  </required_header>
  <id_info>
    <org_study_id>Oxycodone</org_study_id>
    <nct_id>NCT02238340</nct_id>
  </id_info>
  <brief_title>Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery</brief_title>
  <official_title>Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Central Dr. Luis Ortega</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Central Dr. Luis Ortega</source>
  <brief_summary>
    <textblock>
      Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the&#xD;
      patient, including significant cardiovascular and respiratory complications. Apart from the&#xD;
      human suffering that is undeniable pain. Schemes oral analgesia with opioids for the&#xD;
      treatment of DAPO, have shown to be as or more effective than intravenous or epidural&#xD;
      regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone&#xD;
      sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)&#xD;
      undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone&#xD;
      metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at&#xD;
      rest and effort, requirement for rescue intravenous morphine and incidence of side effects to&#xD;
      the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and&#xD;
      patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percents of patients with EVA &lt; 4 to the alt of UCPA, and 6 , 18 postoperatory hours</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percents of patients with adverse events because of treatment</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extended-release oxycodone</intervention_name>
    <description>10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery</description>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Extended- release Oxycodone</intervention_name>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ketoprofen</intervention_name>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
    <other_name>Both groups received ketoprofen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dipirone</intervention_name>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
    <other_name>Both groups received dipirone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexametasone</intervention_name>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
    <other_name>Both groups received dexametasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine IV (rescue)</intervention_name>
    <arm_group_label>Extended-release oxycodone 10mgr</arm_group_label>
    <arm_group_label>Extended-release oxycodone 20 mgr</arm_group_label>
    <other_name>Both groups received Morphine IV (rescue)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II patients between 18 and 60 years old, both sexes, undergoing elective&#xD;
             orthopedic surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of psychotropic medication or illicit drug use&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Opioid use&#xD;
&#xD;
          -  History of postoperative nausea and vomiting&#xD;
&#xD;
          -  Ileus&#xD;
&#xD;
          -  Allergy or intolerance to any of the study drugs&#xD;
&#xD;
          -  Physical or mental inability to use the pain scale, or any surgical complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatriz S Arismendi Gomez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sociedad Venezolana de Anestesiologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Aestesiologia.Hospital &quot;Dr Luis Ortega&quot;</name>
      <address>
        <city>Porlamar</city>
        <state>Nueva Esparta</state>
        <zip>6301</zip>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Venezuela</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Central Dr. Luis Ortega</investigator_affiliation>
    <investigator_full_name>Beatriz Arismendi Gómez</investigator_full_name>
    <investigator_title>Medico Anestesiologo</investigator_title>
  </responsible_party>
  <keyword>Postoperatory pain</keyword>
  <keyword>Oxycodone</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketoprofen</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Oxycodone</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/NCT02238340
org study id: Oxycodone
nct id: NCT02238340
lead sponsor: 
Inadequate control of acute postoperative pain (DAPO) brings deleterious consequences for the
      patient, including significant cardiovascular and respiratory complications. Apart from the
      human suffering that is undeniable pain. Schemes oral analgesia with opioids for the
      treatment of DAPO, have shown to be as or more effective than intravenous or epidural
      regimes, and less expensive. Comparing the effectiveness of 10 to 20 mgs of oxycodone
      sustained release for 12 hours before surgery, into two groups of 20 patients (O-10, O-20)
      undergoing orthopedic surgery, in a scheme involving multimodal ketoprofen, dipyrone
      metoclopramide and dexamethasone. Values were recorded visual analog scale (VAS)for pain at
      rest and effort, requirement for rescue intravenous morphine and incidence of side effects to
      the entry and exit of the PACU (T0, TE) and at 6 and 18 hours postoperatively (T6, T18),and
      patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Percents of patients with EVA < 4 to the alt of UCPA, and 6 , 18 postoperatory hours
time frame: 24 hours
measure: Percents of patients with adverse events because of treatment
time frame: 24 hours
arm group label: Extended-release oxycodone 10mgr
arm group type: Experimental
description: Extended-release oxycodone 10 mgrs , started 12 hours before orthopaedic surgery
arm group label: Extended-release oxycodone 20 mgr
arm group type: Experimental
description: Extended-release oxycodone 20 mgr , started 12 hours before orthopaedic surgery
intervention type: Drug
intervention name: Extended-release oxycodone
description: 10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
intervention type: Drug
intervention name: Extended- release Oxycodone
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
intervention type: Drug
intervention name: ketoprofen
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
other name: Both groups received ketoprofen
intervention type: Drug
intervention name: dipirone
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
other name: Both groups received dipirone
intervention type: Drug
intervention name: dexametasone
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
other name: Both groups received dexametasone
intervention type: Drug
intervention name: Morphine IV (rescue)
arm group label: Extended-release oxycodone 10mgr
arm group label: Extended-release oxycodone 20 mgr
other name: Both groups received Morphine IV (rescue)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Beatriz S Arismendi Gomez, MD
role: Principal Investigator
affiliation: Sociedad Venezolana de Anestesiologia
facility: 
country: Venezuela
responsible party type: Principal Investigator
investigator affiliation: Hospital Central Dr. Luis Ortega
investigator full name: Beatriz Arismendi Gómez
investigator title: Medico Anestesiologo
mesh term: Ketoprofen
mesh term: Morphine
mesh term: Oxycodone