<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/NCT04457557</url>
  </required_header>
  <id_info>
    <org_study_id>MED-INT-20-140</org_study_id>
    <nct_id>NCT04457557</nct_id>
  </id_info>
  <brief_title>Local Anesthetic Concentration and Rebound Pain</brief_title>
  <official_title>Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</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>
      The rebound pain after nerve block could interfere with patient's recovery and&#xD;
      rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The&#xD;
      aim of this study is evaluation of the effect of local anesthetic concentration on rebound&#xD;
      pain after interscalene block for shoulder surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve&#xD;
      block could reduce the postoperative pain effectively. When the effect of nerve block ends,&#xD;
      however, rebound pain could appear. The rebound pain could interfere with patient's recovery&#xD;
      and rehabilitation.&#xD;
&#xD;
      The mechanism of rebound pain is not well known. One of possible mechanism is that the pain&#xD;
      stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The&#xD;
      strength of the block may vary depending on the concentration of the local anesthetic.&#xD;
      Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this&#xD;
      study is evaluation of the effect of local anesthetic concentration on rebound pain after&#xD;
      interscalene block for shoulder surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>
    <intervention_model_description>Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rebound pain score</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared.&#xD;
VAS of pain: 0=no pain ~ 10=very severe pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total postoperative fentanyl dose</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fentanyl bolus injection time</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Number of bolus injection times using patient controlled analgesia (PCA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective satisfaction</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Rebound Pain</condition>
  <arm_group>
    <arm_group_label>Low concentration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interscalene block with 0.15% ropivacaine 15 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual concentration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interscalene block with 0.5% ropivacaine 15 ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reduced concentration of local anesthetic (ropivacaine)</intervention_name>
    <description>Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml</description>
    <arm_group_label>Low concentration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual concentration of local anesthetic (ropivacaine)</intervention_name>
    <description>0.5% ropivacaine 15ml</description>
    <arm_group_label>Usual concentration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective shoulder surgery under general anesthesia and interscalene block for&#xD;
             postoperative pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication of interscalene block: pulmonary disease, lung resection history,&#xD;
             brachial nerve injury&#xD;
&#xD;
          -  Diabetic neuropathy&#xD;
&#xD;
          -  Adverse drug reaction history to ropivacaine, fentanyl&#xD;
&#xD;
          -  Impaired coagulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In Kyong Yi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>In Kyong Yi, MD</last_name>
    <phone>+82-31-219-7522</phone>
    <email>lyrin01@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ajou university school of medicine</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>In Kyong Yi, MD</last_name>
      <phone>+82-10-3012-6972</phone>
      <email>lyrin01@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Yoon Jung Chae, MD</last_name>
      <phone>+82-31-219-5689</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>In-kyong Yi</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will provide it when we have a reasonable request.</ipd_description>
  </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/NCT04457557
org study id: MED-INT-20-140
nct id: NCT04457557
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The rebound pain after nerve block could interfere with patient's recovery and
      rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The
      aim of this study is evaluation of the effect of local anesthetic concentration on rebound
      pain after interscalene block for shoulder surgery.
Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve
      block could reduce the postoperative pain effectively. When the effect of nerve block ends,
      however, rebound pain could appear. The rebound pain could interfere with patient's recovery
      and rehabilitation.

      The mechanism of rebound pain is not well known. One of possible mechanism is that the pain
      stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The
      strength of the block may vary depending on the concentration of the local anesthetic.
      Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this
      study is evaluation of the effect of local anesthetic concentration on rebound pain after
      interscalene block for shoulder surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.
measure: Rebound pain score
time frame: 48 hours after surgery
description: It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared.
VAS of pain: 0=no pain ~ 10=very severe pain
measure: total postoperative fentanyl dose
time frame: 48 hours after surgery
description: Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery
measure: fentanyl bolus injection time
time frame: 48 hours after surgery
description: Number of bolus injection times using patient controlled analgesia (PCA)
measure: Subjective satisfaction
time frame: 48 hours after surgery
description: Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)
arm group label: Low concentration
arm group type: Experimental
description: Interscalene block with 0.15% ropivacaine 15 ml
arm group label: Usual concentration
arm group type: Active Comparator
description: Interscalene block with 0.5% ropivacaine 15 ml
intervention type: Other
intervention name: Reduced concentration of local anesthetic (ropivacaine)
description: Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml
arm group label: Low concentration
intervention type: Other
intervention name: Usual concentration of local anesthetic (ropivacaine)
description: 0.5% ropivacaine 15ml
arm group label: Usual concentration
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: In Kyong Yi, MD
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: In Kyong Yi, MD
phone: +82-31-219-7522
email: lyrin01@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: In-kyong Yi
investigator title: Assistant professor
mesh term: Ropivacaine
mesh term: Anesthetics, Local
mesh term: Anesthetics
sharing ipd: No
ipd description: We will provide it when we have a reasonable request.