<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/NCT02982109</url>
  </required_header>
  <id_info>
    <org_study_id>REGSKANE-625361</org_study_id>
    <nct_id>NCT02982109</nct_id>
  </id_info>
  <brief_title>Pain Evaluation of Venous Cannulation to Predict Postoperative Pain</brief_title>
  <official_title>Prediction of Postoperative Pain From Individually Assessed Pain Intensity Levels Associated With Venous Cannulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have recently reported a relationship between pain induced by peripheral&#xD;
      venous cannulation and postoperative pain. The purpose of this study is to validate this&#xD;
      method of postoperative pain prediction in a larger cohort subjected to different types of&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The investigators will study all adult (&gt;18 years old) patients going through surgery at&#xD;
           the site during a defined period of time. Before induction of anesthesia participants&#xD;
           will be asked to assess (in VAS units) the pain intensity associated with peripheral&#xD;
           venous cannulation. The maximum level of postoperative pain intensity will be recorded&#xD;
           in the post-anesthesia care unit.&#xD;
&#xD;
        -  After the endpoint of the study, the patient records will be reviewed, and de-identified&#xD;
           relevant data be recorded and analyzed in the Statistical Package for the Social&#xD;
           Sciences (SPSS) software.&#xD;
&#xD;
        -  Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation&#xD;
           assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those&#xD;
           scoring &lt; 2.0 - corresponding to a difference in maximum postoperative pain intensity of&#xD;
           almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80&#xD;
           % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain&#xD;
           intensity level between patients scoring above or below 2.0 VAS units, respectively,&#xD;
           would require 55 patients in each group subjected to the same kind of surgery. With 4&#xD;
           groups of cases and controls 440 patients would need to be included. As the study is&#xD;
           strictly observational, 600 patients will be included to make up for possible missing&#xD;
           data.&#xD;
&#xD;
        -  Statistics: The Mann-Whitney U- test will be used to compare differences in&#xD;
           postoperative pain intensity levels, and the Pearson Chi-square test to compare&#xD;
           proportions of patients with moderate or severe postoperative pain, in patients&#xD;
           differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic&#xD;
           regression analysis will be used to adjust for gender and age and to evaluate the&#xD;
           predictive ability of proposed method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">May 22, 2017</completion_date>
  <primary_completion_date type="Actual">May 22, 2017</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>Maximum postoperative pain intensity (0.0-10.0 VAS units)</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Patients scoring their pain associated with venous cannulation to &lt;2 VAS units will be compared to patients scoring ≥2 VAS units considering median level of maximum postoperative pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk of developing moderate to severe postoperative pain</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>Proportion of patients with moderate or severe (≥4 VAS units) postoperative pain will be compared between groups of patients scoring &lt;/≥ 2 VAS units on peripheral venous cannulation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of gender</measure>
    <time_frame>2 hours after surgery</time_frame>
    <description>With logistic regression analysis investigate the potential influence of gender on the predictive ability of this test.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Postop pain level 1</arm_group_label>
    <description>Minor postoperative pain anticipated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postop pain level 2</arm_group_label>
    <description>Might experience postoperative pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postop pain level 3</arm_group_label>
    <description>Moderate pain/substantial surgery performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Postop pain level 4</arm_group_label>
    <description>Severe postoperative pain expected/major surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective surgery at Hallands Hospital Halmstad&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-80 years old&#xD;
&#xD;
          -  Scheduled for surgery in Halmstad&#xD;
&#xD;
          -  Prepared for surgery in the preoperative ward or ward 71 (day-case or direct&#xD;
             admittance)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to handle the Visual Analog Scale&#xD;
&#xD;
          -  Hospitalized already before surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna KM Persson, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lund University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hallands Hospital Halmstad</name>
      <address>
        <city>Halmstad</city>
        <state>Halland</state>
        <zip>30581</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lund University</investigator_affiliation>
    <investigator_full_name>Anna P Persson</investigator_full_name>
    <investigator_title>M.D.</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>
  <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/NCT02982109
org study id: REGSKANE-625361
nct id: NCT02982109
lead sponsor: 
has dmc: No
The investigators have recently reported a relationship between pain induced by peripheral
      venous cannulation and postoperative pain. The purpose of this study is to validate this
      method of postoperative pain prediction in a larger cohort subjected to different types of
      surgery.
-  The investigators will study all adult (>18 years old) patients going through surgery at
           the site during a defined period of time. Before induction of anesthesia participants
           will be asked to assess (in VAS units) the pain intensity associated with peripheral
           venous cannulation. The maximum level of postoperative pain intensity will be recorded
           in the post-anesthesia care unit.

        -  After the endpoint of the study, the patient records will be reviewed, and de-identified
           relevant data be recorded and analyzed in the Statistical Package for the Social
           Sciences (SPSS) software.

        -  Sample size assessment: In a previous study patients scoring ≥ 2.0 on venous cannulation
           assessed their median pain postoperatively at 5.8 VAS units compared with 2.9 in those
           scoring < 2.0 - corresponding to a difference in maximum postoperative pain intensity of
           almost three VAS units. To statistically confirm, with unpaired non-parametric tests, 80
           % power (β), and 95% probability (1- α), half of that difference (1.5 VAS units) in pain
           intensity level between patients scoring above or below 2.0 VAS units, respectively,
           would require 55 patients in each group subjected to the same kind of surgery. With 4
           groups of cases and controls 440 patients would need to be included. As the study is
           strictly observational, 600 patients will be included to make up for possible missing
           data.

        -  Statistics: The Mann-Whitney U- test will be used to compare differences in
           postoperative pain intensity levels, and the Pearson Chi-square test to compare
           proportions of patients with moderate or severe postoperative pain, in patients
           differing in pain scores (above or below 2.0 VAS units) on venous cannulation. Logistic
           regression analysis will be used to adjust for gender and age and to evaluate the
           predictive ability of proposed method.
observational model: Cohort
time perspective: Prospective
measure: Maximum postoperative pain intensity (0.0-10.0 VAS units)
time frame: 2 hours after surgery
description: Patients scoring their pain associated with venous cannulation to <2 VAS units will be compared to patients scoring ≥2 VAS units considering median level of maximum postoperative pain intensity.
measure: Risk of developing moderate to severe postoperative pain
time frame: 2 hours after surgery
description: Proportion of patients with moderate or severe (≥4 VAS units) postoperative pain will be compared between groups of patients scoring </≥ 2 VAS units on peripheral venous cannulation.
measure: Influence of gender
time frame: 2 hours after surgery
description: With logistic regression analysis investigate the potential influence of gender on the predictive ability of this test.
arm group label: Postop pain level 1
description: Minor postoperative pain anticipated
arm group label: Postop pain level 2
description: Might experience postoperative pain
arm group label: Postop pain level 3
description: Moderate pain/substantial surgery performed
arm group label: Postop pain level 4
description: Severe postoperative pain expected/major surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anna KM Persson, M.D
role: Principal Investigator
affiliation: Lund University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Lund University
investigator full name: Anna P Persson
investigator title: M.D.
mesh term: Pain, Postoperative
sharing ipd: No