<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/NCT03019562</url>
  </required_header>
  <id_info>
    <org_study_id>KHUH 2016-09-047</org_study_id>
    <nct_id>NCT03019562</nct_id>
  </id_info>
  <brief_title>Oxycodone vs. Fentanyl in Early Postoperative Pain After Total Hip Replacement</brief_title>
  <official_title>Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oxycodone is one of the most widely used opioids for pain treatment. Many studies&#xD;
      demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the&#xD;
      efficacy and side effects of bolus intravenous of oxycodone injection compared to those of&#xD;
      fentanyl in patients after total hip replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxycodone is one of the most widely used opioids for pain treatment. There have been several&#xD;
      studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the&#xD;
      same potency with morphine. Many studies demonstrated good efficacy of oxycodone on&#xD;
      postoperative pain. In this study, we designed a prospective, randomized, and double-blind&#xD;
      study to assess the efficacy and side effects of bolus intravenous of oxycodone injection&#xD;
      compared to those of fentanyl in patients who underwent the total hip replacement surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain measurement using Numeric Rating Scale(NRS)</measure>
    <time_frame>Immediately after surgery</time_frame>
    <description>Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Additional doses of fentanyl for pain management</measure>
    <time_frame>From immediately after surgery to 2 days after surgery</time_frame>
    <description>0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse effect</measure>
    <time_frame>From immediately after surgery to 2 days after surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Oxycodone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4mg of oxycodone iv bolus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50ug of fentanyl iv bolus</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)</description>
    <arm_group_label>Oxycodone</arm_group_label>
    <other_name>Oxynorm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),</description>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  19-65 years of age&#xD;
&#xD;
          -  ASA physical status classification I or II&#xD;
&#xD;
          -  Scheduled for total hip replacement surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to study drugs&#xD;
&#xD;
          -  Patient with asthma or COPD, patient who is severely respiratory depressed&#xD;
&#xD;
          -  Renal of hepatic insufficiency&#xD;
&#xD;
          -  Epileptic status&#xD;
&#xD;
          -  Intracranial lesion associated with increased intracranial pressure&#xD;
&#xD;
          -  Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mi Kyeong Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyunghee University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Youngsoon Kim, MD, PhD</last_name>
    <phone>+82-2-958-8598</phone>
    <email>ys.kim@khu.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hee Yong Kang, MD</last_name>
    <phone>+82-2-958-8589</phone>
    <email>ujuabba@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youngsoon Kim</last_name>
      <phone>958-8589</phone>
      <email>ys.kim@khu.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Mi Kyeong Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>postoperative pain</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>Fentanyl</mesh_term>
    <mesh_term>Oxycodone</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/NCT03019562
org study id: KHUH 2016-09-047
nct id: NCT03019562
lead sponsor: 
has dmc: Yes
Oxycodone is one of the most widely used opioids for pain treatment. Many studies
      demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the
      efficacy and side effects of bolus intravenous of oxycodone injection compared to those of
      fentanyl in patients after total hip replacement surgery.
Oxycodone is one of the most widely used opioids for pain treatment. There have been several
      studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the
      same potency with morphine. Many studies demonstrated good efficacy of oxycodone on
      postoperative pain. In this study, we designed a prospective, randomized, and double-blind
      study to assess the efficacy and side effects of bolus intravenous of oxycodone injection
      compared to those of fentanyl in patients who underwent the total hip replacement surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Postoperative pain measurement using Numeric Rating Scale(NRS)
time frame: Immediately after surgery
description: Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)
measure: Additional doses of fentanyl for pain management
time frame: From immediately after surgery to 2 days after surgery
description: 0-6 hours, 6-12 hours, 12-24 hours, 24-48 hours after surgery
measure: Adverse effect
time frame: From immediately after surgery to 2 days after surgery
arm group label: Oxycodone
arm group type: Experimental
description: 4mg of oxycodone iv bolus
arm group label: Fentanyl
arm group type: Active Comparator
description: 50ug of fentanyl iv bolus
intervention type: Drug
intervention name: Oxycodone
description: 4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)
arm group label: Oxycodone
other name: Oxynorm
intervention type: Drug
intervention name: Fentanyl
description: 50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),
arm group label: Fentanyl
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mi Kyeong Kim, MD, PhD
role: Principal Investigator
affiliation: Kyunghee University Medical Center
last name: Youngsoon Kim, MD, PhD
phone: +82-2-958-8598
email: ys.kim@khu.ac.kr
last name: Hee Yong Kang, MD
phone: +82-2-958-8589
email: ujuabba@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Mi Kyeong Kim
investigator title: Associate Professor
mesh term: Pain, Postoperative
mesh term: Fentanyl
mesh term: Oxycodone
sharing ipd: No