<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/NCT02230865</url>
  </required_header>
  <id_info>
    <org_study_id>MIRPEX-3</org_study_id>
    <nct_id>NCT02230865</nct_id>
  </id_info>
  <brief_title>Prediction of Acute Postoperative Pain and Analgesic Consumption</brief_title>
  <acronym>MIRPEX-3</acronym>
  <official_title>Prediction of Acute Postoperative Pain and Analgesic Consumption by Preoperative Responses to Experimental Pain in Patients Undergoing Chest Wall Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasper Grosen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain is an expected part of surgical recovery but effective pain management remains&#xD;
      challenging. The high variability in postoperative pain experience and analgesic treatment&#xD;
      response between patients is part of the challenge. Few studies have yet combined&#xD;
      preoperative assessment of responses to experimental pain with measurements of cognitive and&#xD;
      emotional processes in the prediction of postoperative pain.&#xD;
&#xD;
      We hypothesize, that preoperative evoked brain potentials (using standard&#xD;
      electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain&#xD;
      modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related&#xD;
      catastrophic thinking are useful clinical predictors of postoperative pain and analgesic&#xD;
      consumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preselected preoperative predictor variables/individual patient characteristics include the&#xD;
      following:&#xD;
&#xD;
        -  Evoked brain potentials (using standard electroencephalographic brain imaging)&#xD;
&#xD;
        -  Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)&#xD;
&#xD;
        -  Pressure pain detection and tolerance thresholds in muscle (m.quadriceps)&#xD;
&#xD;
        -  Pressure pain tolerance thresholds in bone (sternum and tibia)&#xD;
&#xD;
        -  Heat pain tolerance threshold in skin (forearm)&#xD;
&#xD;
        -  Responses to the Situational and Dispositional Pain Catastrophizing Scale&#xD;
&#xD;
        -  Response to the State-Trait and Anxiety Inventory&#xD;
&#xD;
        -  Response to the Beck's Depression Inventory&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Postoperative pain intensity</measure>
    <time_frame>Within the first 5 days after surgery</time_frame>
    <description>11-point (0-10) numerical rating scale of pain intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain unpleasantness</measure>
    <time_frame>Within the first 5 days after surgery</time_frame>
    <description>11-point (0-10) numerical rating scale of pain unpleasantness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative consumption of analgesics</measure>
    <time_frame>Within the first 5 days after surgery</time_frame>
    <description>The use of all pain-related treatments, including rescue analgesics and any other concomitant pain treatments.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <description>Minimally invasive repair of pectus excavatum</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with funnel chest (pectus excavatum) undergoing corrective chest wall surgery at&#xD;
        Aarhus University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective minimally invasive surgical correction of funnel chest (pectus excavatum&#xD;
&#xD;
          -  age ≥15 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous thoracic surgical interventions&#xD;
&#xD;
          -  Presence of diseases affecting the central and/or peripheral nervous system&#xD;
&#xD;
          -  Presence of chronic pain conditions&#xD;
&#xD;
          -  Inability to speak and/or understand Danish&#xD;
&#xD;
          -  Inability to understand and participate in the experimental pain session&#xD;
&#xD;
          -  Presence of psychiatric disorders&#xD;
&#xD;
          -  History of frostbite in the non-dominant upper limb&#xD;
&#xD;
          -  Presence of sores or cuts on non-dominant upper limb&#xD;
&#xD;
          -  Presence of cardiovascular disease&#xD;
&#xD;
          -  History of fainting and/or seizures&#xD;
&#xD;
          -  Presence of fractures of the non-dominant upper limb&#xD;
&#xD;
          -  Presence of Reynaud's phenomenon.&#xD;
&#xD;
        Secondary exclusions included:&#xD;
&#xD;
          -  Insensitivity to experimental cold pressor pain&#xD;
&#xD;
          -  Lack of epidural catheter placement&#xD;
&#xD;
          -  Re-operation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asbjørn M Drewes, MD, PhD, DMSci</last_name>
    <role>Study Director</role>
    <affiliation>Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kasper Grosen, MHSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans K Pilegaard, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lene Vase, MSc (Psychology), PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Psychology, Aarhus University, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mogens Pfeiffer-Jensen, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vibeke E Hjortdal, MD, PhD, DMSci</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anne E Olesen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikkel Gram, MScEE</last_name>
    <role>Study Chair</role>
    <affiliation>Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kasper Grosen, MHSc, PhD</last_name>
    <phone>78464224</phone>
    <email>kasper.grosen@rm.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Asbjørn M Drewes, MD, PhD, DMSci</last_name>
    <phone>97660000</phone>
    <email>amd@rn.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Deparment of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <link>
    <url>http://www.mech-sense.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Grosen K, Vase L, Pilegaard HK, Pfeiffer-Jensen M, Drewes AM. Conditioned pain modulation and situational pain catastrophizing as preoperative predictors of pain following chest wall surgery: a prospective observational cohort study. PLoS One. 2014 Feb 26;9(2):e90185. doi: 10.1371/journal.pone.0090185. eCollection 2014.</citation>
    <PMID>24587268</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 29, 2015</last_update_submitted>
  <last_update_submitted_qc>May 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Kasper Grosen</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Funnel chest (Pectus excavatum)</keyword>
  <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/NCT02230865
org study id: MIRPEX-3
nct id: NCT02230865
lead sponsor: 
has dmc: No
Pain is an expected part of surgical recovery but effective pain management remains
      challenging. The high variability in postoperative pain experience and analgesic treatment
      response between patients is part of the challenge. Few studies have yet combined
      preoperative assessment of responses to experimental pain with measurements of cognitive and
      emotional processes in the prediction of postoperative pain.

      We hypothesize, that preoperative evoked brain potentials (using standard
      electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain
      modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related
      catastrophic thinking are useful clinical predictors of postoperative pain and analgesic
      consumption.
Preselected preoperative predictor variables/individual patient characteristics include the
      following:

        -  Evoked brain potentials (using standard electroencephalographic brain imaging)

        -  Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)

        -  Pressure pain detection and tolerance thresholds in muscle (m.quadriceps)

        -  Pressure pain tolerance thresholds in bone (sternum and tibia)

        -  Heat pain tolerance threshold in skin (forearm)

        -  Responses to the Situational and Dispositional Pain Catastrophizing Scale

        -  Response to the State-Trait and Anxiety Inventory

        -  Response to the Beck's Depression Inventory
observational model: Cohort
time perspective: Prospective
measure: Postoperative pain intensity
time frame: Within the first 5 days after surgery
description: 11-point (0-10) numerical rating scale of pain intensity
measure: Postoperative pain unpleasantness
time frame: Within the first 5 days after surgery
description: 11-point (0-10) numerical rating scale of pain unpleasantness
measure: Postoperative consumption of analgesics
time frame: Within the first 5 days after surgery
description: The use of all pain-related treatments, including rescue analgesics and any other concomitant pain treatments.
arm group label: Surgery
description: Minimally invasive repair of pectus excavatum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Asbjørn M Drewes, MD, PhD, DMSci
role: Study Director
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
last name: Kasper Grosen, MHSc, PhD
role: Principal Investigator
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
last name: Hans K Pilegaard, MD
role: Study Chair
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
last name: Lene Vase, MSc (Psychology), PhD
role: Study Chair
affiliation: Department of Psychology, Aarhus University, Denmark
last name: Mogens Pfeiffer-Jensen, MD, PhD
role: Study Chair
affiliation: Aarhus University Hospital
last name: Vibeke E Hjortdal, MD, PhD, DMSci
role: Study Chair
affiliation: Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark
last name: Anne E Olesen, PhD
role: Study Chair
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
last name: Mikkel Gram, MScEE
role: Study Chair
affiliation: Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Denmark
last name: Kasper Grosen, MHSc, PhD
phone: 78464224
email: kasper.grosen@rm.dk
last name: Asbjørn M Drewes, MD, PhD, DMSci
phone: 97660000
email: amd@rn.dk
facility: 
status: Recruiting
country: Denmark
url: http://www.mech-sense.com
description: Related Info
citation: Grosen K, Vase L, Pilegaard HK, Pfeiffer-Jensen M, Drewes AM. Conditioned pain modulation and situational pain catastrophizing as preoperative predictors of pain following chest wall surgery: a prospective observational cohort study. PLoS One. 2014 Feb 26;9(2):e90185. doi: 10.1371/journal.pone.0090185. eCollection 2014.
PMID: 24587268
responsible party type: Sponsor-Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Kasper Grosen
investigator title: PhD
mesh term: Pain, Postoperative