<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/NCT02204878</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-Liver-Dynastat</org_study_id>
    <nct_id>NCT02204878</nct_id>
  </id_info>
  <brief_title>Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy</brief_title>
  <official_title>A Randomized, Phase IV Study Exploring the Role of Parecoxib Sodium for Postoperative Pain Management in Open Hepatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To searching the role of parecoxib sodium for postoperative pain management in open&#xD;
      hepatectomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">August 2015</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS scores change</measure>
    <time_frame>at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>liver function change</measure>
    <time_frame>befor and 42hrs and 66hrs after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>kidney function change</measure>
    <time_frame>befor and 42hrs and 66hrs after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood ammonia level change</measure>
    <time_frame>before and 42hrs, 66hrs after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>ESR change</measure>
    <time_frame>before and 42hrs and 66hrs after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>portal blood flow change</measure>
    <time_frame>before and after surgery</time_frame>
    <description>Ultrasound evaluation</description>
  </other_outcome>
  <other_outcome>
    <measure>CRP change</measure>
    <time_frame>before and 42hrs and 66hrs after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>IL4 change</measure>
    <time_frame>before and 42hrs and 66hrs after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>IL6 change</measure>
    <time_frame>before and 42hrs and 66hrs after surgery</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>portal blood pressure change</measure>
    <time_frame>before and after surgery</time_frame>
    <description>Ultrasound evaluation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hepatic Hemangioma Located in the Right Liver</condition>
  <condition>Laparotomy Surgery</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1ml of saline was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. 1ml saline Q12h will be given within 72 hours after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parecoxib Sodium</intervention_name>
    <description>Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery</description>
    <arm_group_label>AT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-70 years old;&#xD;
&#xD;
          -  Hepatic hemangioma patients who will undergo laparotomy surgery: diameter of hepatic&#xD;
             hemangioma between 5-15cm, located in the right liver;&#xD;
&#xD;
          -  Child score 5-6;&#xD;
&#xD;
          -  BMI: 19-25;&#xD;
&#xD;
          -  ASA: Ⅰ ~ Ⅱ grade;&#xD;
&#xD;
          -  No comorbidities such as diabetes, hypertension, cardio renal or respiratory&#xD;
             dysfunction, mental illness;&#xD;
&#xD;
          -  No known allergies;&#xD;
&#xD;
          -  No participation in other clinical trials within 2 months;&#xD;
&#xD;
          -  Have been informed consent.&#xD;
&#xD;
          -  Surgery-related: right subcostal incision, surgical time&lt; 4 hours, hepatic pedicle&#xD;
             occlusion time&lt; 20 minutes, bleeding&lt; 1000ml, no blood transfusions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chronic pain，long-term use of analgesic drugs or alcohol abuse;&#xD;
&#xD;
          -  Allergic to NSAIDs, opioids or sulfa drugs;&#xD;
&#xD;
          -  Coagulopathy or other hematological disorder；&#xD;
&#xD;
          -  Active peptic ulcer, gastrointestinal bleeding, inflammatory bowel disease;&#xD;
&#xD;
          -  Pregnant or lactating;&#xD;
&#xD;
          -  Mentally unstable to use PCA;&#xD;
&#xD;
          -  Preoperative pain caused by other disease;&#xD;
&#xD;
          -  Analgesic drugs or NSAIDs intake one week before surgery;&#xD;
&#xD;
          -  Preoperative systemic inflammatory response syndrome;&#xD;
&#xD;
          -  Preoperative chemotherapy or radiotherapy;&#xD;
&#xD;
          -  Preoperative or postoperative use of steroids;&#xD;
&#xD;
          -  Operative time&gt; 4 hours, hepatic pedicle occlusion time&gt; 20 minutes, blood loss&gt;&#xD;
             1000ml, or intraoperative blood transfusion;&#xD;
&#xD;
          -  TBil&gt; 34 umol/L、PT prolongation&gt; 3S、ALB&lt; 30 g/L、or Child score&gt; 7 within 42 hours&#xD;
             after surgery；&#xD;
&#xD;
          -  Bleeding、biliary fistula, intra-abdominal infections or other postoperative&#xD;
             complications.&#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_contact>
    <last_name>Shunda Du, Doctor</last_name>
    <phone>86-010-69156042</phone>
    <email>shundadu@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking union medical college hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shunda Du, Doctor</last_name>
      <phone>8613911832900</phone>
      <email>shundadu@sina.com</email>
    </contact>
    <investigator>
      <last_name>Shunda Du, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 30, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parecoxib</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/NCT02204878
org study id: PUMCH-Liver-Dynastat
nct id: NCT02204878
lead sponsor: 
has dmc: Yes
To searching the role of parecoxib sodium for postoperative pain management in open
      hepatectomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: VAS scores change
time frame: at rest and after activity befor and 6hrs, 18hrs, 30hrs, 42hrs, 54hrs and 66hrs after surgery
measure: liver function change
time frame: befor and 42hrs and 66hrs after surgery
measure: kidney function change
time frame: befor and 42hrs and 66hrs after surgery
measure: blood ammonia level change
time frame: before and 42hrs, 66hrs after surgery
measure: ESR change
time frame: before and 42hrs and 66hrs after surgery
measure: portal blood flow change
time frame: before and after surgery
description: Ultrasound evaluation
measure: CRP change
time frame: before and 42hrs and 66hrs after surgery
measure: IL4 change
time frame: before and 42hrs and 66hrs after surgery
measure: IL6 change
time frame: before and 42hrs and 66hrs after surgery
measure: portal blood pressure change
time frame: before and after surgery
description: Ultrasound evaluation
arm group label: A
arm group type: Placebo Comparator
description: 1ml of saline was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. 1ml saline Q12h will be given within 72 hours after surgery
arm group label: AT
arm group type: Experimental
description: Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
intervention type: Drug
intervention name: Parecoxib Sodium
description: Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
arm group label: AT
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shunda Du, Doctor
phone: 86-010-69156042
email: shundadu@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Hemangioma
mesh term: Pain, Postoperative
mesh term: Parecoxib