<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/NCT03808220</url>
  </required_header>
  <id_info>
    <org_study_id>UW 18-660</org_study_id>
    <nct_id>NCT03808220</nct_id>
  </id_info>
  <brief_title>Prospective Observational Study on Postoperative Pain and Side Effect</brief_title>
  <acronym>Pain Out</acronym>
  <official_title>Improvement in Postoperative Pain Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing&#xD;
      and analysing clinical and patient-reported outcome data of postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome&#xD;
      quality and decision support in acute pain conditions. It collects demographic, clinical and&#xD;
      outcome data, using a validated assessment tool available in multiple languages.&#xD;
&#xD;
      The registry part of the project aims at performing population-based research. Furthermore,&#xD;
      its infrastructure allows for the conduct of prospective studies comparing the effectiveness&#xD;
      of processes of care.&#xD;
&#xD;
      The benchmark part of the project provides the medical community with a unique, user-friendly&#xD;
      system to improve treatment of patients with postoperative pain. A web-based information&#xD;
      system, featuring two main functions, was developed:&#xD;
&#xD;
      a feedback and benchmarking system which provides participating sites with continuously&#xD;
      updating data and analyses about the quality of care they provide compared to other&#xD;
      institutions and allows identification of best clinical practice.&#xD;
&#xD;
      a knowledge library which provides clinicians with easily accessible and regularly updated&#xD;
      summaries of evidence-based recommendations tailored to specific post-operative situations.&#xD;
&#xD;
      From 2016 on, sub-projects in Mexico, China and several European countries have started. This&#xD;
      programs take place over a period of two years during which collaborators carry out a Quality&#xD;
      Improvement project in their hospital using methodology provided by PAIN OUT. This includes&#xD;
      collection of baseline data in a first phase, analysis of findings according to a protocol&#xD;
      provided by PAIN OUT, review of findings and developement of improvement measures,&#xD;
      implementation of the improvements and assessment of outcomes after a second phase of data&#xD;
      collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Questionnaire on postoperative pain treatment</measure>
    <time_frame>first postoperative day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire on patients' perception of pain treatment outcome</measure>
    <time_frame>first postoperative day</time_frame>
    <description>questions related to worst pain since surgery, least pain since surgery, time in pain, interference of pain with activities, affect of pain on mood and emotions, pain therapy side effects, pain relief, wish for more treatment, information on treatment, participation in decisions, satisfaction, non-medical treatment methods and pre-hospital existence of pain.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>post-surgical patients</arm_group_label>
    <description>post-surgical patients &gt; 18 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pediatric patients post-op day 1</arm_group_label>
    <description>pediatric patients &gt; 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>postoperative pain intensity</intervention_name>
    <description>estimate the postoperative pain intensity by using a scaling system via questionnaire</description>
    <arm_group_label>pediatric patients post-op day 1</arm_group_label>
    <arm_group_label>post-surgical patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>preoperative pain frequency</intervention_name>
    <description>estimate the preoperative pain intensity by using a scaling system via questionnaire</description>
    <arm_group_label>pediatric patients post-op day 1</arm_group_label>
    <arm_group_label>post-surgical patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Side effect</intervention_name>
    <description>investigate the presence of any side effect</description>
    <arm_group_label>pediatric patients post-op day 1</arm_group_label>
    <arm_group_label>post-surgical patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult post-surgical patients in hospitals on post-op day 1&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;= 18 years or &gt;= 4 years for sub-project QUIPSI/PAIN OUTinfant&#xD;
&#xD;
          -  patient is post-op day 1&#xD;
&#xD;
          -  patient is at least 6 hours on the ward&#xD;
&#xD;
          -  patient has given consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient cannot communicate&#xD;
&#xD;
          -  patient is cognitively impaired&#xD;
&#xD;
          -  patient is asleep&#xD;
&#xD;
          -  patient is too ill&#xD;
&#xD;
          -  patient does not want to fill in the questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Winfried Meissner</last_name>
    <role>Study Director</role>
    <affiliation>Jena University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chi Wai Cheung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Chi-Wai Cheung</investigator_full_name>
    <investigator_title>Professor Cheung Chi Wai</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT03808220
org study id: UW 18-660
nct id: NCT03808220
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing
      and analysing clinical and patient-reported outcome data of postoperative pain.
PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome
      quality and decision support in acute pain conditions. It collects demographic, clinical and
      outcome data, using a validated assessment tool available in multiple languages.

      The registry part of the project aims at performing population-based research. Furthermore,
      its infrastructure allows for the conduct of prospective studies comparing the effectiveness
      of processes of care.

      The benchmark part of the project provides the medical community with a unique, user-friendly
      system to improve treatment of patients with postoperative pain. A web-based information
      system, featuring two main functions, was developed:

      a feedback and benchmarking system which provides participating sites with continuously
      updating data and analyses about the quality of care they provide compared to other
      institutions and allows identification of best clinical practice.

      a knowledge library which provides clinicians with easily accessible and regularly updated
      summaries of evidence-based recommendations tailored to specific post-operative situations.

      From 2016 on, sub-projects in Mexico, China and several European countries have started. This
      programs take place over a period of two years during which collaborators carry out a Quality
      Improvement project in their hospital using methodology provided by PAIN OUT. This includes
      collection of baseline data in a first phase, analysis of findings according to a protocol
      provided by PAIN OUT, review of findings and developement of improvement measures,
      implementation of the improvements and assessment of outcomes after a second phase of data
      collection.
observational model: Cohort
time perspective: Prospective
measure: Questionnaire on postoperative pain treatment
time frame: first postoperative day
measure: Questionnaire on patients' perception of pain treatment outcome
time frame: first postoperative day
description: questions related to worst pain since surgery, least pain since surgery, time in pain, interference of pain with activities, affect of pain on mood and emotions, pain therapy side effects, pain relief, wish for more treatment, information on treatment, participation in decisions, satisfaction, non-medical treatment methods and pre-hospital existence of pain.
arm group label: post-surgical patients
description: post-surgical patients > 18 years
arm group label: pediatric patients post-op day 1
description: pediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)
intervention type: Behavioral
intervention name: postoperative pain intensity
description: estimate the postoperative pain intensity by using a scaling system via questionnaire
arm group label: pediatric patients post-op day 1
arm group label: post-surgical patients
intervention type: Behavioral
intervention name: preoperative pain frequency
description: estimate the preoperative pain intensity by using a scaling system via questionnaire
arm group label: pediatric patients post-op day 1
arm group label: post-surgical patients
intervention type: Behavioral
intervention name: Side effect
description: investigate the presence of any side effect
arm group label: pediatric patients post-op day 1
arm group label: post-surgical patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: No
last name: Winfried Meissner
role: Study Director
affiliation: Jena University Hospital
last name: Chi Wai Cheung, MD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Chi-Wai Cheung
investigator title: Professor Cheung Chi Wai
mesh term: Pain, Postoperative