<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/NCT02235506</url>
  </required_header>
  <id_info>
    <org_study_id>apsj0901</org_study_id>
    <nct_id>NCT02235506</nct_id>
  </id_info>
  <brief_title>A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty</brief_title>
  <official_title>A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeungnam University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeungnam University College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators compared continuous epidural infusion with combined continuous femoral and&#xD;
      single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and&#xD;
      secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation&#xD;
      indices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The parcicipants were randomly assingned to epidural infusion group and femoral sciatic&#xD;
      block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level&#xD;
      using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a&#xD;
      rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic&#xD;
      nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to&#xD;
      femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral&#xD;
      catheter at a rate of 5ml/hr. The incidence of side effects is measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the incidence of side effects</measure>
    <time_frame>during 5 days after the end of operation</time_frame>
    <description>Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>during 5 days after the end of operation</time_frame>
    <description>Pain according to visual analogue scale at rest and on mobilization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade at rest and on mobilization</measure>
    <time_frame>during 5 days after the end of operation</time_frame>
    <description>Motor blockade is estimated using a modified Bromage scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>epidural infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>femoral sciatic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>epidural infusion</intervention_name>
    <description>Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.</description>
    <arm_group_label>epidural infusion</arm_group_label>
    <other_name>continuous lumbar epidural block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>femoral sciatic</intervention_name>
    <description>After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.</description>
    <arm_group_label>femoral sciatic</arm_group_label>
    <other_name>femoral nerve block and sciatic nerve block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>epidural infusion</intervention_name>
    <description>Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.</description>
    <arm_group_label>epidural infusion</arm_group_label>
    <other_name>perifix epidural catheter, B-Braoun</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>femoral sciatic</intervention_name>
    <description>After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.</description>
    <arm_group_label>femoral sciatic</arm_group_label>
    <other_name>contiplex catheter and stimuplex needle; B-Braun</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Classification I-II&#xD;
&#xD;
          -  total knee arthroplasty&#xD;
&#xD;
          -  18-90 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to the local anesthetics&#xD;
&#xD;
          -  cognitive impairment such as dementia&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  motor and sensory impairment&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  BMI &gt;39&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangjin Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sangjin Park, M.D.</last_name>
    <phone>82-53-620-3366</phone>
    <email>apsj0718@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Yeungnam University hospital</name>
      <address>
        <city>Daegu</city>
        <zip>705-035</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Duckhee Lee, M.D.</last_name>
      <phone>82-53-620-3365</phone>
      <email>apsj0718@naver.com</email>
    </contact>
    <investigator>
      <last_name>Sangjin Park, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>July 14, 2015</last_update_submitted>
  <last_update_submitted_qc>July 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeungnam University College of Medicine</investigator_affiliation>
    <investigator_full_name>Sangjin Park</investigator_full_name>
    <investigator_title>assistant professor</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/NCT02235506
org study id: apsj0901
nct id: NCT02235506
lead sponsor: 
has dmc: Yes
The investigators compared continuous epidural infusion with combined continuous femoral and
      single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and
      secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation
      indices.
The parcicipants were randomly assingned to epidural infusion group and femoral sciatic
      block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level
      using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a
      rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic
      nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to
      femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral
      catheter at a rate of 5ml/hr. The incidence of side effects is measured.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: the incidence of side effects
time frame: during 5 days after the end of operation
description: Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.
measure: Pain
time frame: during 5 days after the end of operation
description: Pain according to visual analogue scale at rest and on mobilization.
measure: Motor blockade at rest and on mobilization
time frame: during 5 days after the end of operation
description: Motor blockade is estimated using a modified Bromage scale
arm group label: epidural infusion
arm group type: Experimental
description: In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation,
arm group label: femoral sciatic
arm group type: Experimental
description: In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr.
intervention type: Procedure
intervention name: epidural infusion
description: Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
arm group label: epidural infusion
other name: continuous lumbar epidural block
intervention type: Procedure
intervention name: femoral sciatic
description: After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
arm group label: femoral sciatic
other name: femoral nerve block and sciatic nerve block
intervention type: Device
intervention name: epidural infusion
description: Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
arm group label: epidural infusion
other name: perifix epidural catheter, B-Braoun
intervention type: Device
intervention name: femoral sciatic
description: After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
arm group label: femoral sciatic
other name: contiplex catheter and stimuplex needle; B-Braun
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sangjin Park, M.D.
role: Principal Investigator
affiliation: Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
last name: Sangjin Park, M.D.
phone: 82-53-620-3366
email: apsj0718@naver.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yeungnam University College of Medicine
investigator full name: Sangjin Park
investigator title: assistant professor
mesh term: Pain, Postoperative