<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/NCT03275207</url>
  </required_header>
  <id_info>
    <org_study_id>20170819</org_study_id>
    <nct_id>NCT03275207</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine for Prevention of Chronic Postoperative Pain</brief_title>
  <official_title>a Randomized Controlled Trial of Dexmedetomidine on Chronic Postoperative Pain After Breast and Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhongda Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously&#xD;
      affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can&#xD;
      improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after&#xD;
      surgery. It is most common in patients who undergoing breast or thoracic surgery.&#xD;
      Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after&#xD;
      surgery. In our study, patients were randomly assigned to one of the two group to receive&#xD;
      0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The&#xD;
      pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">October 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</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>
    <intervention_model_description>paitents undergoing breast or thoracic surgery</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the pain intensity measure</measure>
    <time_frame>12 months</time_frame>
    <description>Self reported pain intensity in rest and activity will be recorded at day 1 before sugery, month 3, month 6, month 12 after sugery. The intensity of pain was measured by numeric rating scale (0=no pain, 10=worst possible pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>anxiety</measure>
    <time_frame>12 months</time_frame>
    <description>The anxiety will be self reported by patents at day 1 before surgery, month 3, month 6, month 12 after surgery.The anxiety will be scored by a Visual Analogue Scale of anxiety (0=no anxiety, 10=worst possible anxiety)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>12 months</time_frame>
    <description>The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep disturbance</measure>
    <time_frame>12 months</time_frame>
    <description>Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Chronic Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>an equal volume of saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline</intervention_name>
    <description>an equal volume of saline</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexmedetomidine</intervention_name>
    <description>dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative</description>
    <arm_group_label>dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have been 18 to 65 yr old, and been scheduled for breast or thoracic&#xD;
             surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with limitations of self-expression or visual dysfunction or having emergency&#xD;
             surgery, a severe psychiatric illness, or chronic pain problems in the chest area for&#xD;
             longer than 2 months before the surgery,or patients who could not provide informed&#xD;
             consent were excluded.&#xD;
&#xD;
          -  Pregnant women and prisoners were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Jian-jun, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongda Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Jian-jun, PhD</last_name>
    <phone>13357739238</phone>
    <email>yjyangjj@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wang Xing-ming</last_name>
    <phone>18205185859</phone>
    <email>mingxingwang2011@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>December 3, 2017</last_update_submitted>
  <last_update_submitted_qc>December 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
    <investigator_full_name>Jian-jun Yang</investigator_full_name>
    <investigator_title>director, department of anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Chronic pain</keyword>
  <keyword>CPSP</keyword>
  <keyword>Dexmedetomidine</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>Dexmedetomidine</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/NCT03275207
org study id: 20170819
nct id: NCT03275207
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Chronic postoperative pain (CPSP) is common symptom in patients after surgery, seriously
      affected the quality of life. Accumulating evidences have demonstrated dexmedetomidine can
      improve chronic pain. However, the prevention of dexmedetomidine on CPSP remain uncertain.
Chronic postoperative pain (CPSP) is defined as pain persisting at least 3 months after
      surgery. It is most common in patients who undergoing breast or thoracic surgery.
      Dexmedetomidine, a adrenergic α2 agonists, can alleviate the postoperative pain 24 h after
      surgery. In our study, patients were randomly assigned to one of the two group to receive
      0.5mg/kg/h infusion dexmedetomidine (Group D, n=57) or normal saline (Group C, n=57). The
      pain scales were evaluated day 1, day 2, day 3, month 3, month 6 after surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: paitents undergoing breast or thoracic surgery
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: the pain intensity measure
time frame: 12 months
description: Self reported pain intensity in rest and activity will be recorded at day 1 before sugery, month 3, month 6, month 12 after sugery. The intensity of pain was measured by numeric rating scale (0=no pain, 10=worst possible pain)
measure: anxiety
time frame: 12 months
description: The anxiety will be self reported by patents at day 1 before surgery, month 3, month 6, month 12 after surgery.The anxiety will be scored by a Visual Analogue Scale of anxiety (0=no anxiety, 10=worst possible anxiety)
measure: depression
time frame: 12 months
description: The depression will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by a questionnaire
measure: sleep disturbance
time frame: 12 months
description: Sleep disturbance will be evaluated at day 1 before surgery, month 3, month 6, month 12 after sugery by questionnaires.
arm group label: control group
arm group type: Placebo Comparator
description: an equal volume of saline
arm group label: dexmedetomidine
arm group type: Experimental
description: dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
intervention type: Drug
intervention name: saline
description: an equal volume of saline
arm group label: control group
intervention type: Drug
intervention name: dexmedetomidine
description: dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
arm group label: dexmedetomidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yang Jian-jun, PhD
role: Principal Investigator
affiliation: Zhongda Hospital
last name: Yang Jian-jun, PhD
phone: 13357739238
email: yjyangjj@126.com
last name: Wang Xing-ming
phone: 18205185859
email: mingxingwang2011@163.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Zhongda Hospital
investigator full name: Jian-jun Yang
investigator title: director, department of anesthesiology
mesh term: Pain, Postoperative
mesh term: Dexmedetomidine
sharing ipd: No