<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/NCT04453462</url>
  </required_header>
  <id_info>
    <org_study_id>MTU-EC-OT-6-227/61</org_study_id>
    <nct_id>NCT04453462</nct_id>
  </id_info>
  <brief_title>Efficacy of Local Direct Median Nerve Block</brief_title>
  <official_title>Efficacy of Local Direct Median Nerve Block VS Brachial Plexus Block in Endoscopic Carpal Tunnel Release</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thammasat University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thammasat University</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>
      Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is&#xD;
      indicated when failed conservative treatment. Although it can be done either with local&#xD;
      anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The&#xD;
      study is conducted to compare the efficacy of two methods and we hypothesized that the local&#xD;
      direct median nerve block has effectiveness in intraoperative pain control not inferior to&#xD;
      brachial plexus block in endoscopic carpal tunnel release.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is randomized-control trial conducted in single center (Orthopaedic department,&#xD;
      Faculty of medicine, Thammasat university) The patients with failed conservative treatment of&#xD;
      carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized&#xD;
      block-of-4 method.The local direct median nerve block is done by the surgeon and brachial&#xD;
      plexus block in done by single anesthesiologist after that the patient will be operated with&#xD;
      1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate&#xD;
      postoperative the blinded observer will ask the patient about interaoperative pain in visual&#xD;
      analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative&#xD;
      pain in case record form.The patient will return the case record form at 2-week and also&#xD;
      stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional&#xD;
      outcome (Thai version Bonton questionaire)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative pain measured as visual analog scale (VAS)</measure>
    <time_frame>Immediate postoperative period</time_frame>
    <description>Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain&#xD;
Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain measured as visual analog scale (VAS)</measure>
    <time_frame>2 hours, 4 hours, 6 hours and 12 hours postoperative period</time_frame>
    <description>Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain&#xD;
The pateint is asked to record the 2 hours, 4 hours, 6 hours and 12 hours postoperative pain in case record form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome of the hand measured as Thai Version Boston Questionnaire</measure>
    <time_frame>2, 4, 12, 24 weeks postoperative period</time_frame>
    <description>There are 2 parts of Thai Version Boston Questionnaire&#xD;
Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome)&#xD;
Functional severity scores (FSS) 8 items (total score 0-40; hign score means worse outcome)&#xD;
The follow up will be 1, 4, 12, 24 weeks to assess functional outcome with Thai Version Boston Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Local direct median nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brachial plexus block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic carpal tunnel release under local direct median nerve block</intervention_name>
    <description>local direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)</description>
    <arm_group_label>Local direct median nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic carpal tunnel release under brachial plexus block</intervention_name>
    <description>brachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)</description>
    <arm_group_label>Brachial plexus block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with carpal tunnel syndrome, confirmed by EMG&#xD;
&#xD;
          2. Failed conservative treatment 3 months&#xD;
&#xD;
          3. Age ≥18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic history of xylocaine&#xD;
&#xD;
          2. Any other condition that can cause carpal tunnel syndrome or peripheral neuropathy&#xD;
             e.g. DM, hypothyroidism, pregnancy, tumor&#xD;
&#xD;
          3. Any patient that has been coverted to open carpal tunnel release&#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>Chinnakart Boonyasirikool, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics, Faculty of Medicine Thammasat University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thammasat University hospital</name>
      <address>
        <city>Khlong Luang</city>
        <state>Pathumthani</state>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>April 30, 2023</last_update_submitted>
  <last_update_submitted_qc>April 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Thammasat University</investigator_affiliation>
    <investigator_full_name>Kittipong Siriboonpipattana</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <keyword>Endoscopic carpal tunnel release</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</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/NCT04453462
org study id: MTU-EC-OT-6-227/61
nct id: NCT04453462
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Carpal tunnel syndrome is the most common compressive neuropathy. Carpal tunnel release is
      indicated when failed conservative treatment. Although it can be done either with local
      anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. The
      study is conducted to compare the efficacy of two methods and we hypothesized that the local
      direct median nerve block has effectiveness in intraoperative pain control not inferior to
      brachial plexus block in endoscopic carpal tunnel release.
The study is randomized-control trial conducted in single center (Orthopaedic department,
      Faculty of medicine, Thammasat university) The patients with failed conservative treatment of
      carpal tunnel syndrome confirmed by EMG are enrolled and ramdomized with computerized
      block-of-4 method.The local direct median nerve block is done by the surgeon and brachial
      plexus block in done by single anesthesiologist after that the patient will be operated with
      1-portal endoscopic carpal tunnel release (Agee technque) by single surgeon. Immediate
      postoperative the blinded observer will ask the patient about interaoperative pain in visual
      analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative
      pain in case record form.The patient will return the case record form at 2-week and also
      stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional
      outcome (Thai version Bonton questionaire)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Intraoperative pain measured as visual analog scale (VAS)
time frame: Immediate postoperative period
description: Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain
Immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale
measure: Postoperative pain measured as visual analog scale (VAS)
time frame: 2 hours, 4 hours, 6 hours and 12 hours postoperative period
description: Visual analog scale (VAS) from 0-10 0 means no pain 5 means moderate pain 10 means worst possible pain
The pateint is asked to record the 2 hours, 4 hours, 6 hours and 12 hours postoperative pain in case record form.
measure: Functional outcome of the hand measured as Thai Version Boston Questionnaire
time frame: 2, 4, 12, 24 weeks postoperative period
description: There are 2 parts of Thai Version Boston Questionnaire
Symptom severity scores (SSS) 11 items (total score 0-55; hign score means worse outcome)
Functional severity scores (FSS) 8 items (total score 0-40; hign score means worse outcome)
The follow up will be 1, 4, 12, 24 weeks to assess functional outcome with Thai Version Boston Questionnaire
arm group label: Local direct median nerve block
arm group type: Active Comparator
description: The local anesthetic technique is proposed by Wood SH and Logan AM in 1999 by using the plastic catheter to inject the anesthetic 4 cm proximally to the incision site direct over the median and ulna nerve
arm group label: Brachial plexus block
arm group type: Active Comparator
description: The brachial plexus block technique is axillary block performed under ultrasound-guided by the well-trained anesthesiologist.
intervention type: Procedure
intervention name: Endoscopic carpal tunnel release under local direct median nerve block
description: local direct median nerve block is performed by surgeon using the 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
arm group label: Local direct median nerve block
intervention type: Procedure
intervention name: Endoscopic carpal tunnel release under brachial plexus block
description: brachial plexus block under ultrasound-guided is performed by experienced single anesthesiologist using the 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before the endoscopic carpal tunnel release(1-portal Agee technique)
arm group label: Brachial plexus block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Chinnakart Boonyasirikool, MD
role: Principal Investigator
affiliation: Department of Orthopaedics, Faculty of Medicine Thammasat University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Thammasat University
investigator full name: Kittipong Siriboonpipattana
investigator title: Resident
mesh term: Carpal Tunnel Syndrome