<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/NCT03823846</url>
  </required_header>
  <id_info>
    <org_study_id>2017-084</org_study_id>
    <nct_id>NCT03823846</nct_id>
  </id_info>
  <brief_title>the Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain</brief_title>
  <official_title>The Effect of Doctor-nurse-patient Cooperative Analgesic Linkage Program on Movement Evoked Pain After Laparotomy for Patients With Hepatobiliary and Pancreatic Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To establish doctor-nurse-patient cooperative analgesic linkage program.&#xD;
&#xD;
        2. Evaluate the effect of doctor-nurse-patient cooperative analgesic linkage program on&#xD;
           movement evoked pain after laparotomy for patients with hepatobiliary and pancreatic&#xD;
           disease through quasi-experimental study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part I The establishment of doctor-nurse-patient cooperative analgesic linkage program&#xD;
&#xD;
        1. Based on literature review and clinical investigation results, initially make a&#xD;
           doctor-nurse-patient cooperative analgesic linkage program through discussion in experts&#xD;
           consensus meeting.&#xD;
&#xD;
        2. Using Delphi method, determine the doctor-nurse-patient cooperative analgesic linkage&#xD;
           program after two rounds consultation.&#xD;
&#xD;
      Part II Clinical application study of doctor-nurse-patient cooperative analgesic linkage&#xD;
      program.&#xD;
&#xD;
      Conduct non-randomized control study in corresponding period. 80 patients from two wards&#xD;
      which managed by the same medical and nursing team were divided into experimental and control&#xD;
      group. Patients in the control group were received routine post-operative analgesia pump and&#xD;
      analgesics, and functional rehabilitation, while ones in the experimental group were received&#xD;
      doctor-nurse-patient cooperative analgesic linkage program. Evaluate the effect of pain&#xD;
      control during rehabilitation, adverse events during rehabilitation, patients' satisfaction&#xD;
      of pain control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>movement evoked pain (Numerical rating scale)</measure>
    <time_frame>Each rehabilitation within 3 days after surgery</time_frame>
    <description>Assess movement evoked pain during rehabilitation. Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain at rest (Numerical rating scale)</measure>
    <time_frame>Each rehabilitation within 3 days after surgery</time_frame>
    <description>Assess pain at rest before rehabilitation.Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>satisfaction questionare of pain control</measure>
    <time_frame>three days after surgery</time_frame>
    <description>Patients answer the questionare and rate the satisfaction of pain control. The questionnaire includes 7 items indicating different aspect of pain control. Patients rate their satisfaction using score. The score ranges from 1 to 5. 1 is extremely not satisfied, 5 is extremely satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time of first bowel movement</measure>
    <time_frame>three days after surgery</time_frame>
    <description>Record the time of first bowel movement after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total dose of analgesics</measure>
    <time_frame>three days after surgery</time_frame>
    <description>record and calculate the total dose of analgesics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain at night (Numerical rating scale)</measure>
    <time_frame>three days after surgery</time_frame>
    <description>Asess the pain at rest during night.Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events during rehabilitation</measure>
    <time_frame>three days after surgery</time_frame>
    <description>adverse events during rehabilitation, such as nausea, vomiting, headache, falls</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Anaplasia</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the control group were received routine analgesic and functional rehabilitation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Routine Dezocine injection</intervention_name>
    <description>Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>Dezocine 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjusted Dezocine injection</intervention_name>
    <description>Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Dezocine 2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Routine Dynastat or Flurbiprofen Axetil jinjection</intervention_name>
    <description>Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>Dynastat or Flurbiprofen Axetil 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adjusted Dynastat or Flurbiprofen Axetil jinjection</intervention_name>
    <description>Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>Dynastat or Flurbiprofen Axetil 2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>postoperative rehabilitation</intervention_name>
    <description>Rehabilitation was conducted at 8:00am and 2:00pm.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <other_name>rehabilitation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal analgesia pump administration</intervention_name>
    <description>Dose of analgesia pump was added if needed.</description>
    <arm_group_label>control group</arm_group_label>
    <other_name>analgesia pump 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>adjusted analgesia pump administration</intervention_name>
    <description>Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <other_name>analgesia pump 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consent to the study.&#xD;
&#xD;
          -  Normal cognitive ability and speak Chinese&#xD;
&#xD;
          -  Patients received selective laparotomy under general anesthesia.&#xD;
&#xD;
          -  Length of stay is longer than three days.&#xD;
&#xD;
          -  Patients who are allowed to do rehabilitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with Severe organic disease, chronic pain, history of brain injury, history&#xD;
             of drug or alcohol addiction.&#xD;
&#xD;
          -  Psychiatric patients&#xD;
&#xD;
          -  Consciousness disorder&#xD;
&#xD;
          -  Patients contradict to opioid medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caijuan Xu, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caijuan Xu, master</last_name>
    <phone>057187783887</phone>
    <email>xucaijuan@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caijuan Xu, master</last_name>
      <phone>057187783887</phone>
      <email>zrhlb@zju.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yuping Zhang, master</last_name>
      <phone>057187783568</phone>
      <email>zhangyuping@zju.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>movement evoked pain</keyword>
  <keyword>analgesia</keyword>
  <keyword>general surgery</keyword>
  <keyword>hepatobiliary and pancreatic disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anaplasia</mesh_term>
    <mesh_term>Pancreatic Diseases</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>Flurbiprofen</mesh_term>
    <mesh_term>Flurbiprofen axetil</mesh_term>
    <mesh_term>Parecoxib</mesh_term>
    <mesh_term>Dezocine</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/NCT03823846
org study id: 2017-084
nct id: NCT03823846
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
1. To establish doctor-nurse-patient cooperative analgesic linkage program.

        2. Evaluate the effect of doctor-nurse-patient cooperative analgesic linkage program on
           movement evoked pain after laparotomy for patients with hepatobiliary and pancreatic
           disease through quasi-experimental study.
Part I The establishment of doctor-nurse-patient cooperative analgesic linkage program

        1. Based on literature review and clinical investigation results, initially make a
           doctor-nurse-patient cooperative analgesic linkage program through discussion in experts
           consensus meeting.

        2. Using Delphi method, determine the doctor-nurse-patient cooperative analgesic linkage
           program after two rounds consultation.

      Part II Clinical application study of doctor-nurse-patient cooperative analgesic linkage
      program.

      Conduct non-randomized control study in corresponding period. 80 patients from two wards
      which managed by the same medical and nursing team were divided into experimental and control
      group. Patients in the control group were received routine post-operative analgesia pump and
      analgesics, and functional rehabilitation, while ones in the experimental group were received
      doctor-nurse-patient cooperative analgesic linkage program. Evaluate the effect of pain
      control during rehabilitation, adverse events during rehabilitation, patients' satisfaction
      of pain control.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: movement evoked pain (Numerical rating scale)
time frame: Each rehabilitation within 3 days after surgery
description: Assess movement evoked pain during rehabilitation. Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.
measure: pain at rest (Numerical rating scale)
time frame: Each rehabilitation within 3 days after surgery
description: Assess pain at rest before rehabilitation.Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.
measure: satisfaction questionare of pain control
time frame: three days after surgery
description: Patients answer the questionare and rate the satisfaction of pain control. The questionnaire includes 7 items indicating different aspect of pain control. Patients rate their satisfaction using score. The score ranges from 1 to 5. 1 is extremely not satisfied, 5 is extremely satisfied.
measure: the time of first bowel movement
time frame: three days after surgery
description: Record the time of first bowel movement after surgery
measure: total dose of analgesics
time frame: three days after surgery
description: record and calculate the total dose of analgesics
measure: pain at night (Numerical rating scale)
time frame: three days after surgery
description: Asess the pain at rest during night.Numerical rating scale is a common pain rating scale. The score ranges from 0 to 10. 0 is no pain, 10 is the most severe pain.
measure: adverse events during rehabilitation
time frame: three days after surgery
description: adverse events during rehabilitation, such as nausea, vomiting, headache, falls
arm group label: Experimental Group
arm group type: Experimental
description: Patients in the experimental group were received doctor-nurse-patient cooperative analgesic linkage program.
arm group label: control group
arm group type: Active Comparator
description: Patients in the control group were received routine analgesic and functional rehabilitation.
intervention type: Drug
intervention name: Routine Dezocine injection
description: Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
arm group label: control group
other name: Dezocine 1
intervention type: Drug
intervention name: Adjusted Dezocine injection
description: Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
arm group label: Experimental Group
other name: Dezocine 2
intervention type: Drug
intervention name: Routine Dynastat or Flurbiprofen Axetil jinjection
description: Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
arm group label: control group
other name: Dynastat or Flurbiprofen Axetil 1
intervention type: Drug
intervention name: Adjusted Dynastat or Flurbiprofen Axetil jinjection
description: Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.
arm group label: Experimental Group
other name: Dynastat or Flurbiprofen Axetil 2
intervention type: Other
intervention name: postoperative rehabilitation
description: Rehabilitation was conducted at 8:00am and 2:00pm.
arm group label: Experimental Group
arm group label: control group
other name: rehabilitation
intervention type: Drug
intervention name: normal analgesia pump administration
description: Dose of analgesia pump was added if needed.
arm group label: control group
other name: analgesia pump 1
intervention type: Drug
intervention name: adjusted analgesia pump administration
description: Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.
arm group label: Experimental Group
other name: analgesia pump 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caijuan Xu, master
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Caijuan Xu, master
phone: 057187783887
email: xucaijuan@zju.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Anaplasia
mesh term: Pancreatic Diseases
mesh term: Pain, Postoperative
mesh term: Flurbiprofen
mesh term: Flurbiprofen axetil
mesh term: Parecoxib
mesh term: Dezocine
sharing ipd: No