<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/NCT04400708</url>
  </required_header>
  <id_info>
    <org_study_id>2004-253-11</org_study_id>
    <nct_id>NCT04400708</nct_id>
  </id_info>
  <brief_title>Single-injection Adductor Canal Block for Total Knee Arthroplasty Under Spinal Anesthesia</brief_title>
  <official_title>The Effect of Postoperative Single-injection Adductor Canal Block for Multimodal Pain Control in Patients Receiving Total Knee Arthroplasty Under Spinal Anesthesia</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>
    <has_dmc>Yes</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>
      This study evaluates the effect of the single-injection adductor canal block in patients&#xD;
      receiving total knee arthroplasty under spinal anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the effect of the single-injection adductor canal block in&#xD;
      patients receiving total knee arthroplasty under spinal anesthesia. The effect of the&#xD;
      single-injection adductor canal and continuous adductor canal block in patients receiving&#xD;
      total knee arthroplasty under general anesthesia has been well established. However, due to&#xD;
      the residual effect of spinal anesthesia, the effect of the single-injection adductor canal&#xD;
      block needs to be determined. The investigators hypothesize that the single-injection&#xD;
      adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Anticipated">May 26, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 29, 2021</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the sum of pain score</measure>
    <time_frame>2 hours, 6 hours, 12 hours, and 24 hours after intervention</time_frame>
    <description>VAS pain score (0 to 10) is measured using numeric pain rating scale at 2 hours, 6 hours, 12 hours, and 24 hours 0: no pain, 10: worst pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>2 hours, 6 hours, 12 hours, and 24 hours after intervention</time_frame>
    <description>degree of postoperative nausea and vomiting (0 to 3) 0: no nausea, no vomiting, 1: nausea present, but no vomiting, 2: nausea present, vomiting once, 3: vomiting repeatedly within 30 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative opioid consumption</measure>
    <time_frame>2 hours, 6 hours, 12 hours, and 24 hours intervention</time_frame>
    <description>amount of postoperative opioid consumption based on oral morphine equivalent daily dose</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>normal saline injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% ropivacaine injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>adductor canal block</intervention_name>
    <description>After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.</description>
    <arm_group_label>test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients receiving total-knee arthroplasty under spinal anesthesia&#xD;
&#xD;
          -  ASA class 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection at the needle injection site&#xD;
&#xD;
          -  hard for pain evaluation&#xD;
&#xD;
          -  CRPS patient with lower extremity symptom&#xD;
&#xD;
          -  chronic opioid user&#xD;
&#xD;
          -  those with side effect to local anesthetics&#xD;
&#xD;
          -  those getting revision total-knee arthroplasty or with the previous operation at the&#xD;
             same knee area&#xD;
&#xD;
          -  those getting the surgery under general anesthesia due to the failed spinal anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin-Tae Kim, MD. PhD.</last_name>
      <phone>82-2-2072-3664</phone>
      <email>jintae73@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 14, 2021</last_update_submitted>
  <last_update_submitted_qc>March 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</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>professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04400708
org study id: 2004-253-11
nct id: NCT04400708
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of the single-injection adductor canal block in patients
      receiving total knee arthroplasty under spinal anesthesia.
This study aims to evaluate the effect of the single-injection adductor canal block in
      patients receiving total knee arthroplasty under spinal anesthesia. The effect of the
      single-injection adductor canal and continuous adductor canal block in patients receiving
      total knee arthroplasty under general anesthesia has been well established. However, due to
      the residual effect of spinal anesthesia, the effect of the single-injection adductor canal
      block needs to be determined. The investigators hypothesize that the single-injection
      adductor canal block will decrease the total sum of 2h, 6h, 12h, and 24h pain score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: the sum of pain score
time frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
description: VAS pain score (0 to 10) is measured using numeric pain rating scale at 2 hours, 6 hours, 12 hours, and 24 hours 0: no pain, 10: worst pain
measure: Postoperative nausea and vomiting
time frame: 2 hours, 6 hours, 12 hours, and 24 hours after intervention
description: degree of postoperative nausea and vomiting (0 to 3) 0: no nausea, no vomiting, 1: nausea present, but no vomiting, 2: nausea present, vomiting once, 3: vomiting repeatedly within 30 minutes.
measure: Postoperative opioid consumption
time frame: 2 hours, 6 hours, 12 hours, and 24 hours intervention
description: amount of postoperative opioid consumption based on oral morphine equivalent daily dose
arm group label: control group
arm group type: Sham Comparator
description: normal saline injection
arm group label: test group
arm group type: Experimental
description: 0.5% ropivacaine injection
intervention type: Procedure
intervention name: adductor canal block
description: After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.
arm group label: test group
intervention type: Procedure
intervention name: control group
description: After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.
arm group label: control group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: professor