<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/NCT03011359</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0903</org_study_id>
    <nct_id>NCT03011359</nct_id>
  </id_info>
  <brief_title>The Comparison of Postoperative Pain After Colon Resection in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment</brief_title>
  <official_title>The Comparison of Postoperative Pain After Colon Resection in Intravenous</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</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>
      Colon resection is one of the major surgery, the postoperative pain is so severe that it is&#xD;
      necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The&#xD;
      most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively&#xD;
      insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce&#xD;
      the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,&#xD;
      which leads to the adverse effects in patients who are very sensitive to narcotic analgesics.&#xD;
      And the patient's satisfaction to the PCA may be low.&#xD;
&#xD;
      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode&#xD;
      setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out&#xD;
      time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a&#xD;
      new mode, so that the administered rate and amount of drug can be increased or decreased&#xD;
      according to the patient's use of bolus button. Therefore, this PCA device can be implemented&#xD;
      to the conventional mode, and added the function of automatically controlling the basal rate&#xD;
      and administered amount of drug according to the use demand of the patient. However, since&#xD;
      there are few studies related to this new mode of PCA, more research is needed in patients&#xD;
      with postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 17, 2018</start_date>
  <completion_date type="Actual">December 7, 2018</completion_date>
  <primary_completion_date type="Actual">December 7, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain</measure>
    <time_frame>At postoperative 6 hours</time_frame>
    <description>At 6 hours after surgery, the pain scores will be measured by numeric rating scale range from 0 to 10.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>1) Conventional PCA mode</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2) Optimizing B.I PCA mode</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Optimizing Basal Infusion (New) PCA mode(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optimizing B.I (New) PCA mode</intervention_name>
    <description>In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: ~ 6 hr: 1.5 - 3.5 ml, 6-24 hr: 1 - 3 ml, 24 hr ~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 3.5 ml (or 0.5 ml).</description>
    <arm_group_label>2) Optimizing B.I PCA mode</arm_group_label>
    <other_name>(Mode setting; total volume: 150 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 10 minutes)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional PCA mode</intervention_name>
    <description>(Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes)</description>
    <arm_group_label>1) Conventional PCA mode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subjects who undergoing colon resection due to colon cancer&#xD;
&#xD;
          2. ASA class Ⅰ-Ⅲ&#xD;
&#xD;
          3. Written consents obtained to participate voluntarily in this clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sudden change of surgical plan&#xD;
&#xD;
          2. Patients who have the hypersensitivity to the pain killers including narcotics&#xD;
&#xD;
          3. Patients who are unable to express the degree of pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colon resection</keyword>
  <keyword>Patient Controlled Analgesia</keyword>
  <keyword>Optimizing Basal Infusion Mode</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>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/NCT03011359
org study id: 4-2016-0903
nct id: NCT03011359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colon resection is one of the major surgery, the postoperative pain is so severe that it is
      necessary to use additional analgesics as well as a patient controlled analgesia (PCA). The
      most common pain management of this surgery is the intravenous (IV) PCA. If it is relatively
      insufficient amount of narcotic analgesics ,in the case of IV PCA, may be failed to reduce
      the pain effectively. Consequently, it may result in the a lot of rescue analgesics use,
      which leads to the adverse effects in patients who are very sensitive to narcotic analgesics.
      And the patient's satisfaction to the PCA may be low.

      For the recently released PCA instrument 'PAINSTOP', the investigators can specify the mode
      setting including total volume, flow rate (basal rate) per hour, bolus dose, and lock out
      time (LOT). Furthermore, this device can be set to optimize basal infusion (B.I), which is a
      new mode, so that the administered rate and amount of drug can be increased or decreased
      according to the patient's use of bolus button. Therefore, this PCA device can be implemented
      to the conventional mode, and added the function of automatically controlling the basal rate
      and administered amount of drug according to the use demand of the patient. However, since
      there are few studies related to this new mode of PCA, more research is needed in patients
      with postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: pain
time frame: At postoperative 6 hours
description: At 6 hours after surgery, the pain scores will be measured by numeric rating scale range from 0 to 10.
arm group label: 1) Conventional PCA mode
arm group type: Experimental
description: (Mode setting; total volume: 140 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 15 minutes)
arm group label: 2) Optimizing B.I PCA mode
arm group type: Active Comparator
description: Optimizing Basal Infusion (New) PCA mode(Mode setting; total volume: 140 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 15 minutes)
intervention type: Other
intervention name: Optimizing B.I (New) PCA mode
description: In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: ~ 6 hr: 1.5 - 3.5 ml, 6-24 hr: 1 - 3 ml, 24 hr ~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 3.5 ml (or 0.5 ml).
arm group label: 2) Optimizing B.I PCA mode
other name: (Mode setting; total volume: 150 ml, flow rate: changable by patients' requirement, bolus volume: 0.5 ml, and LOT: 10 minutes)
intervention type: Other
intervention name: Conventional PCA mode
description: (Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes)
arm group label: 1) Conventional PCA mode
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No