<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/NCT03761550</url>
  </required_header>
  <id_info>
    <org_study_id>2018PHB054-01</org_study_id>
    <nct_id>NCT03761550</nct_id>
  </id_info>
  <brief_title>pMDT in Thoracic Surgery--The Process Implementation Stage</brief_title>
  <official_title>Perioperative Pain Management With Multi-discipline Team(pMDT) in Thoracic Surgery: a Multi-center，Prospective, Observational Study--The Process Implementation Stage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Tumor Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Shenyang Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Xinjiang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Lanzhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming General Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Renmin Hospital of Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henan Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The People's Hospital of Gaozhou</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shaanxi Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liaoning Tumor Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University People's 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>
      The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary&#xD;
      postoperative pain management strategy is the best way to control postoperative pain in&#xD;
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the&#xD;
      thoracic surgery department of Peking University People's Hospital, the investigators have&#xD;
      summarized the experience in multidisciplinary pain management and promoted this study in&#xD;
      multi-centers across the country, hoping that this study can improve the current situation of&#xD;
      acute pain management in patients after thoracic surgery, and at the same time, the&#xD;
      deficiencies of this clinical protocol can be found out and improved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that&#xD;
      occurs immediately after surgery, and its nature is traumatic pain. It may develop into a&#xD;
      chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at&#xD;
      the initial state. It will seriously impact the physiology and psychology of a patient.&#xD;
      According to the study, the postoperative acute pain is one of the risks for postoperative&#xD;
      complications, and it may result in the death of a patient. However, the alleviation of a&#xD;
      postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall&#xD;
      cost for treatment of a patient.&#xD;
&#xD;
      The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary&#xD;
      postoperative pain management strategy is the best way to control postoperative pain in&#xD;
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the&#xD;
      thoracic surgery department of Peking University People's Hospital, the investigators have&#xD;
      summarized the experience in multidisciplinary pain management and promoted this study in&#xD;
      multi-centers across the country, hoping that this study can improve the current situation of&#xD;
      acute pain management in patients after thoracic surgery, and at the same time, the&#xD;
      deficiencies of this clinical protocol can be found out and improved.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of postoperative pain</measure>
    <time_frame>Up to 90 days after surgery.</time_frame>
    <description>The percentage of patients with numerical rating scale（NRS）score greater than 3. The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of patients' satisfaction</measure>
    <time_frame>3 days after surgery.</time_frame>
    <description>The degree of patients' satisfaction on pain managements. Patients were asked to give a score from 0-10 (0 means dissatisfied, 10 means very satisfied).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative duration of stay in hospital</measure>
    <time_frame>Up to 90 days after surgery.</time_frame>
    <description>The duration when patients stay in hospital after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalization rate</measure>
    <time_frame>Up to 90 days after surgery.</time_frame>
    <description>The percentage of patients who are rehospitalized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication incidence rate</measure>
    <time_frame>Up to 90 days after surgery.</time_frame>
    <description>The percentage of patients with complications after surgery.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">480</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Stage 2</arm_group_label>
    <description>The Process Implementation Stage</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>pMDT(Process Implementation)</intervention_name>
    <description>The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.</description>
    <arm_group_label>Stage 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing thoracic surgery in Peking University People's Hospital and other&#xD;
        multi-centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 75, ASA I-II;&#xD;
&#xD;
          -  Patients undergoing thoracoscopic surgery;&#xD;
&#xD;
          -  Patients who can understand and fill in the self-evaluation;&#xD;
&#xD;
          -  Patients who signed the Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women;&#xD;
&#xD;
          -  Patients with preoperative chronic pain and long-term opioid use;&#xD;
&#xD;
          -  Patients with advanced tumors who have received preoperative chemotherapy or who are&#xD;
             expected to receive postoperative chemotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Feng Yi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.</citation>
    <PMID>26329661</PMID>
  </reference>
  <reference>
    <citation>Kelley BP, Shauver MJ, Chung KC. Management of Acute Postoperative Pain in Hand Surgery: A Systematic Review. J Hand Surg Am. 2015 Aug;40(8):1610-9, 1619.e1. doi: 10.1016/j.jhsa.2015.05.024.</citation>
    <PMID>26213198</PMID>
  </reference>
  <reference>
    <citation>Lesin M, Domazet Bugarin J, Puljak L. Factors associated with postoperative pain and analgesic consumption in ophthalmic surgery: a systematic review. Surv Ophthalmol. 2015 May-Jun;60(3):196-203. doi: 10.1016/j.survophthal.2014.10.003. Epub 2014 Nov 5.</citation>
    <PMID>25890623</PMID>
  </reference>
  <reference>
    <citation>Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152.</citation>
    <PMID>26512441</PMID>
  </reference>
  <reference>
    <citation>Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.</citation>
    <PMID>26600464</PMID>
  </reference>
  <reference>
    <citation>Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.</citation>
    <PMID>26509324</PMID>
  </reference>
  <reference>
    <citation>Yun XD, Yin XL, Jiang J, Teng YJ, Dong HT, An LP, Xia YY. Local infiltration analgesia versus femoral nerve block in total knee arthroplasty: a meta-analysis. Orthop Traumatol Surg Res. 2015 Sep;101(5):565-9. doi: 10.1016/j.otsr.2015.03.015. Epub 2015 May 16.</citation>
    <PMID>25987449</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>March 27, 2022</last_update_submitted>
  <last_update_submitted_qc>March 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Yi Feng, MD</investigator_full_name>
    <investigator_title>Director of department of anesthesiology and pain management</investigator_title>
  </responsible_party>
  <keyword>pMDT</keyword>
  <keyword>Pain</keyword>
  <keyword>Thoracic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03761550
org study id: 2018PHB054-01
nct id: NCT03761550
lead sponsor: 
collaborator: 
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is fda regulated drug: No
is fda regulated device: No
The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary
      postoperative pain management strategy is the best way to control postoperative pain in
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the
      thoracic surgery department of Peking University People's Hospital, the investigators have
      summarized the experience in multidisciplinary pain management and promoted this study in
      multi-centers across the country, hoping that this study can improve the current situation of
      acute pain management in patients after thoracic surgery, and at the same time, the
      deficiencies of this clinical protocol can be found out and improved.
The postoperative acute pain refers to the acute pain (usually lasting less than 7 days) that
      occurs immediately after surgery, and its nature is traumatic pain. It may develop into a
      chronic pain, such as a neuropathic pain or a mixed pain, if it is not fully controlled at
      the initial state. It will seriously impact the physiology and psychology of a patient.
      According to the study, the postoperative acute pain is one of the risks for postoperative
      complications, and it may result in the death of a patient. However, the alleviation of a
      postoperative acute pain can shorten the duration of stay in hospital, and reduce the overall
      cost for treatment of a patient.

      The risk of acute and chronic pain after thoracic surgery is high. The multi-disciplinary
      postoperative pain management strategy is the best way to control postoperative pain in
      thoracic surgery. Through nearly one year of experience in implementation of the pMDT in the
      thoracic surgery department of Peking University People's Hospital, the investigators have
      summarized the experience in multidisciplinary pain management and promoted this study in
      multi-centers across the country, hoping that this study can improve the current situation of
      acute pain management in patients after thoracic surgery, and at the same time, the
      deficiencies of this clinical protocol can be found out and improved.
observational model: Case-Only
time perspective: Prospective
measure: Incidence rate of postoperative pain
time frame: Up to 90 days after surgery.
description: The percentage of patients with numerical rating scale（NRS）score greater than 3. The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.
measure: The degree of patients' satisfaction
time frame: 3 days after surgery.
description: The degree of patients' satisfaction on pain managements. Patients were asked to give a score from 0-10 (0 means dissatisfied, 10 means very satisfied).
measure: Postoperative duration of stay in hospital
time frame: Up to 90 days after surgery.
description: The duration when patients stay in hospital after surgery.
measure: Rehospitalization rate
time frame: Up to 90 days after surgery.
description: The percentage of patients who are rehospitalized.
measure: Postoperative complication incidence rate
time frame: Up to 90 days after surgery.
description: The percentage of patients with complications after surgery.
arm group label: Stage 2
description: The Process Implementation Stage
intervention type: Combination Product
intervention name: pMDT(Process Implementation)
description: The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.
arm group label: Stage 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Feng Yi, MD
role: Study Director
affiliation: Peking University People's Hospital
facility: 
country: China
citation: Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.
PMID: 26329661
citation: Kelley BP, Shauver MJ, Chung KC. Management of Acute Postoperative Pain in Hand Surgery: A Systematic Review. J Hand Surg Am. 2015 Aug;40(8):1610-9, 1619.e1. doi: 10.1016/j.jhsa.2015.05.024.
PMID: 26213198
citation: Lesin M, Domazet Bugarin J, Puljak L. Factors associated with postoperative pain and analgesic consumption in ophthalmic surgery: a systematic review. Surv Ophthalmol. 2015 May-Jun;60(3):196-203. doi: 10.1016/j.survophthal.2014.10.003. Epub 2014 Nov 5.
PMID: 25890623
citation: Sharp HT. Management of Postoperative Abdominal Wall Pain. Clin Obstet Gynecol. 2015 Dec;58(4):798-804. doi: 10.1097/GRF.0000000000000152.
PMID: 26512441
citation: Pogatzki-Zahn E, Kutschar P, Nestler N, Osterbrink J. A Prospective Multicentre Study to Improve Postoperative Pain: Identification of Potentialities and Problems. PLoS One. 2015 Nov 24;10(11):e0143508. doi: 10.1371/journal.pone.0143508. eCollection 2015.
PMID: 26600464
citation: Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
PMID: 26509324
citation: Yun XD, Yin XL, Jiang J, Teng YJ, Dong HT, An LP, Xia YY. Local infiltration analgesia versus femoral nerve block in total knee arthroplasty: a meta-analysis. Orthop Traumatol Surg Res. 2015 Sep;101(5):565-9. doi: 10.1016/j.otsr.2015.03.015. Epub 2015 May 16.
PMID: 25987449
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Yi Feng, MD
investigator title: Director of department of anesthesiology and pain management
mesh term: Pain, Postoperative
sharing ipd: Undecided