<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/NCT02240602</url>
  </required_header>
  <id_info>
    <org_study_id>OxyNorm</org_study_id>
    <nct_id>NCT02240602</nct_id>
  </id_info>
  <brief_title>Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery</brief_title>
  <official_title>Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postoperative pain control is required after major abdominal surgery, including laparoscopic&#xD;
      colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control&#xD;
      mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous&#xD;
      oxycodone for pain control after laparoscopic colorectal surgery in Korean.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxycodone is known to be effective in pain control and has less sedative effect than morphine&#xD;
      does. It has been described that distribution of cytochrome P450, which is associated with&#xD;
      metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone&#xD;
      after major abdominal surgery has not been well defined in Korean. The purpose of this study&#xD;
      is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic&#xD;
      colorectal surgery in Korean based on pain score and side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of internal resources&#xD;
  </why_stopped>
  <start_date>July 2015</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resting postoperative pain at 24hr</measure>
    <time_frame>24 hr after surgery</time_frame>
    <description>Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>24 hr after surgery</time_frame>
    <description>Secondary outcome includes any side effect at 24 hr after surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>sedation</measure>
    <time_frame>24 hr after surgery</time_frame>
    <description>sedation with Ramsay sedation score (1-6) at 24 hr after surgery</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Oxycodone, 1.00 mg dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone, 0.03 mg/kg dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone, 0.02 mg/kg dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone, 1.00 mg dose</intervention_name>
    <description>Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.</description>
    <arm_group_label>Oxycodone, 1.00 mg dose</arm_group_label>
    <other_name>OxyNorm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone, 0.03 mg/kg dose</intervention_name>
    <description>Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.</description>
    <arm_group_label>Oxycodone, 0.03 mg/kg dose</arm_group_label>
    <other_name>OxyNorm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone, 0.02 mg/kg dose</intervention_name>
    <description>intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.</description>
    <arm_group_label>Oxycodone, 0.02 mg/kg dose</arm_group_label>
    <other_name>OxyNorm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists class 1,2&#xD;
&#xD;
          -  Expected surgical time between 2 - 6 hours&#xD;
&#xD;
          -  Scheduled for laparoscopic colorectal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe dysfunction of liver, heart, kidney, or lung&#xD;
&#xD;
          -  Cannot understand numeric rating scale of pain&#xD;
&#xD;
          -  Known or suspected allergy to oxycodone&#xD;
&#xD;
          -  Previous history of postoperative nausea or vomiting&#xD;
&#xD;
          -  Medication of antidepressants&#xD;
&#xD;
          -  Postoperative long-term ICU care or prolonged mechanical ventilatory support&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Drug abuser&#xD;
&#xD;
          -  Hypersensitivity reaction to aspirin or NSAIDs&#xD;
&#xD;
          -  Refuse to enroll&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yunseok Jeon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <last_update_submitted>June 14, 2015</last_update_submitted>
  <last_update_submitted_qc>June 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute pain</keyword>
  <keyword>postoperative</keyword>
  <keyword>surgery</keyword>
  <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>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/NCT02240602
org study id: OxyNorm
nct id: NCT02240602
lead sponsor: 
has dmc: Yes
Postoperative pain control is required after major abdominal surgery, including laparoscopic
      colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control
      mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous
      oxycodone for pain control after laparoscopic colorectal surgery in Korean.
Oxycodone is known to be effective in pain control and has less sedative effect than morphine
      does. It has been described that distribution of cytochrome P450, which is associated with
      metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone
      after major abdominal surgery has not been well defined in Korean. The purpose of this study
      is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic
      colorectal surgery in Korean based on pain score and side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: resting postoperative pain at 24hr
time frame: 24 hr after surgery
description: Primary outcome is resting postoperative pain at 24 hr after surgery with numeric rating scale 0-10.
measure: side effects
time frame: 24 hr after surgery
description: Secondary outcome includes any side effect at 24 hr after surgery.
measure: sedation
time frame: 24 hr after surgery
description: sedation with Ramsay sedation score (1-6) at 24 hr after surgery
arm group label: Oxycodone, 1.00 mg dose
arm group type: Experimental
description: Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 1.00 mg with lock out time of 10 min without basal infusion.
arm group label: Oxycodone, 0.03 mg/kg dose
arm group type: Experimental
description: Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.03 mg/kg with lock out time of 10 min without basal infusion.
arm group label: Oxycodone, 0.02 mg/kg dose
arm group type: Experimental
description: Regimen of intravenous patient-controlled analgesia consists of bolus dose of oxycodone 0.02 mg/kg with lock out time of 10 min without basal infusion.
intervention type: Drug
intervention name: Oxycodone, 1.00 mg dose
description: Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
arm group label: Oxycodone, 1.00 mg dose
other name: OxyNorm
intervention type: Drug
intervention name: Oxycodone, 0.03 mg/kg dose
description: Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
arm group label: Oxycodone, 0.03 mg/kg dose
other name: OxyNorm
intervention type: Drug
intervention name: Oxycodone, 0.02 mg/kg dose
description: intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.
arm group label: Oxycodone, 0.02 mg/kg dose
other name: OxyNorm
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yunseok Jeon, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Oxycodone