<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/NCT03252977</url>
  </required_header>
  <id_info>
    <org_study_id>H-1707-078-869</org_study_id>
    <nct_id>NCT03252977</nct_id>
  </id_info>
  <brief_title>Tailored PCA Based on Preoperative Pain Sensitivity</brief_title>
  <official_title>The Effectiveness of Tailored Patient Controlled Analgesia Based on Preoperative Pain Sensitivity in Gynecological Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for&#xD;
      postoperative pain control. However, effective pain control with minimized side effects of&#xD;
      analgesic agents is still challenging. Several studies reported that preoperative pain&#xD;
      sensitivity measured by quantitative sensory test could predict postoperative pain.&#xD;
      Therefore, the investigators planned this trial to evaluate the effectiveness of tailored&#xD;
      patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain&#xD;
      threshold in patients undergoing gynecological surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">November 24, 2017</completion_date>
  <primary_completion_date type="Actual">November 21, 2017</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative nausea</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>Incidence of postoperative nausea</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain scores</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of postoperative vomiting</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>incidence of postoperative vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of postoperative nausea</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>numeric rating scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of other postoperative adverse effects</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative dose of drug that infused via IV PCA</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>cumulative dose of drug that infused via IV PCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of IV PCA clamping</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>Incidence of IV PCA clamping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rescue analgesics</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>amount of administered rescue analgesics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antiemetic agents</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>amount of administered antiemetic agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction score</measure>
    <time_frame>during the postoperative 3 days</time_frame>
    <description>Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Analgesia, Patient-Controlled</condition>
  <arm_group>
    <arm_group_label>Tailored group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tailored regimen of IV PCA according to pain sensitivity</intervention_name>
    <description>In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.</description>
    <arm_group_label>Tailored group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Regimen of IV PCA without considering pain sensitivity</intervention_name>
    <description>In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled to undergo elective gynecological surgery under general anesthesia&#xD;
&#xD;
          -  patients scheduled to use IV PCA for postoperative analgesia&#xD;
&#xD;
          -  patients with American Society of Anesthesiologists (ASA) physical status&#xD;
             classification I, II, III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to fentanyl use&#xD;
&#xD;
          -  inability to communication&#xD;
&#xD;
          -  age less than 18 years, or more than 80 years&#xD;
&#xD;
          -  body weight less than 40kg, or more than 90kg&#xD;
&#xD;
          -  morbid cardiovascular disease&#xD;
&#xD;
          -  pregnancy&#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>Jin-Tae Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Ahmad S, De Oliveira GS Jr, Bialek JM, McCarthy RJ. Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. 2014 May;15(5):857-64. doi: 10.1111/pme.12374. Epub 2014 Feb 12.</citation>
    <PMID>24517836</PMID>
  </reference>
  <reference>
    <citation>Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.</citation>
    <PMID>16129988</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>fentanyl</keyword>
  <keyword>Pain Threshold</keyword>
  <keyword>predicted</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</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/NCT03252977
org study id: H-1707-078-869
nct id: NCT03252977
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Opioids via intravenous patient-controlled analgesia (IV PCA) are widely used for
      postoperative pain control. However, effective pain control with minimized side effects of
      analgesic agents is still challenging. Several studies reported that preoperative pain
      sensitivity measured by quantitative sensory test could predict postoperative pain.
      Therefore, the investigators planned this trial to evaluate the effectiveness of tailored
      patient-controlled analgesia based on preoperative pain sensitivity measured by pressure pain
      threshold in patients undergoing gynecological surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative nausea
time frame: during the postoperative 3 days
description: Incidence of postoperative nausea
measure: postoperative pain scores
time frame: during the postoperative 3 days
description: numeric rating scale
measure: incidence of postoperative vomiting
time frame: during the postoperative 3 days
description: incidence of postoperative vomiting
measure: Severity of postoperative nausea
time frame: during the postoperative 3 days
description: numeric rating scale
measure: Incidence of other postoperative adverse effects
time frame: during the postoperative 3 days
description: itching sense, urinary retention, drowsiness, dry mouth, sweating, respiratory depression
measure: cumulative dose of drug that infused via IV PCA
time frame: during the postoperative 3 days
description: cumulative dose of drug that infused via IV PCA
measure: Incidence of IV PCA clamping
time frame: during the postoperative 3 days
description: Incidence of IV PCA clamping
measure: rescue analgesics
time frame: during the postoperative 3 days
description: amount of administered rescue analgesics
measure: antiemetic agents
time frame: during the postoperative 3 days
description: amount of administered antiemetic agents
measure: satisfaction score
time frame: during the postoperative 3 days
description: Patient's satisfaction with postoperative analgesia (0:totally unsatisfied and 100: totally satisfied)
arm group label: Tailored group
arm group type: Experimental
description: Tailored regimen of IV PCA according to pain sensitivity The regimen of IV PCA will be determined according to preoperative pain sensitivity of patients. Pressure pain threshold will be measured preoperatively in these patients using pressure algometer. Patients with low pain threshold will use high dose IV PCA containing fentanyl 1500mcg, while patients with high pain threshold will use low dose IV PCA containing fentanyl 1000mcg.
arm group label: control group
arm group type: Sham Comparator
description: Regimen of IV PCA without considering pain sensitivity The regimen of IV PCA will be determined according to experimental group patient assignments. Pressure pain threshold will not be measured in these patients. Patients will use IV PCA with fentanyl 1000mcg or fentanyl 1500mcg. The determination will be paired to assignment of experimental group.
intervention type: Other
intervention name: Tailored regimen of IV PCA according to pain sensitivity
description: In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.
arm group label: Tailored group
intervention type: Other
intervention name: Regimen of IV PCA without considering pain sensitivity
description: In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jin-Tae Kim
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Ahmad S, De Oliveira GS Jr, Bialek JM, McCarthy RJ. Thermal quantitative sensory testing to predict postoperative pain outcomes following gynecologic surgery. Pain Med. 2014 May;15(5):857-64. doi: 10.1111/pme.12374. Epub 2014 Feb 12.
PMID: 24517836
citation: Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.
PMID: 16129988
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Associate professor
mesh term: Hypersensitivity
sharing ipd: No