xml: <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/NCT06015204</url>
    </required_header>
    <id_info>
      <org_study_id>2023-02</org_study_id>
      <nct_id>NCT06015204</nct_id>
    </id_info>
    <brief_title>Assessment of the C8 Dermatomal Block With Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block</brief_title>
    <official_title>Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>JongHae Kim</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Research Institute of Medical Science, Daegu Catholic University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Daegu Catholic University Medical Center</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this clinical trial is to investigate the effectiveness of photoplethysmographic&#xD;
        amplitude in assessing the extent of anesthesia in the 8th cervical dermatome in patients&#xD;
        undergoing interscalene brachial plexus block (ISBPB). The main question it aims to answer is&#xD;
  &#xD;
          -  Is there any difference in the post-block changes in photoplethysmographic amplitude&#xD;
             measured from the ipsilateral 5th finger (supplied by the 8th cervical nerve root)&#xD;
             between ISBPBs targeting the C5-to-C6 nerve roots and the C5-to-C8 nerve roots?&#xD;
  &#xD;
          -  Do the changes in photoplethysmographic amplitude represent the extent of anesthesia in&#xD;
             the 8th cervical dermatome? Participants will receive either ISBPB targeting the&#xD;
             C5-to-C6 nerve roots or the C5-to-C8 nerve roots, and then the changes in&#xD;
             photoplethysmographic amplitude will be measured from the 5th finger ipsilateral to&#xD;
             ISBPB.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 13, 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Diagnostic</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 50% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 5% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 10% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 90% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 95% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 99% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 5% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 10% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 50% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 90% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 95% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 99% of maximum photoplethysmographic amplitude is achieved, can be derived.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>15 minutes before the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>15 minutes before the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>15 minutes before the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>25 minutes after the introduction of a block needle</time_frame>
      <description>The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory blockade of the C5 dermatome</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory blockade of the C6 dermatome</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory blockade of the C7 dermatome</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory blockade of the C8 dermatome</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensory blockade of the T1 dermatome</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of shoulder abduction</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of elbow flexion</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of forearm supination</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of forearm pronation</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of finger abduction</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of thumb abduction</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of thumb adduction</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Motor blockade of thumb opposition</measure>
      <time_frame>30 minutes after the introduction of a block needle</time_frame>
      <description>Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline pupil diameter ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>5 minutes before the introduction of a block needle</time_frame>
      <description>Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline pupil diameter contralateral to interscalene brachial plexus block</measure>
      <time_frame>5 minutes before the introduction of a block needle</time_frame>
      <description>Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-block pupil diameter ipsilateral to interscalene brachial plexus block</measure>
      <time_frame>35 minutes after the introduction of a block needle</time_frame>
      <description>Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-block pupil diameter contralateral to interscalene brachial plexus block</measure>
      <time_frame>35 minutes after the introduction of a block needle</time_frame>
      <description>Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain upon a pinch at the skin area for posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)</measure>
      <time_frame>1 minute before the surgical incision</time_frame>
      <description>The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)</measure>
      <time_frame>An average of 1 hour after the introduction of a block needle</time_frame>
      <description>The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)</measure>
      <time_frame>1 minute after surgical incision</time_frame>
      <description>The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Complications related to interscalene brachial plexus block</measure>
      <time_frame>35 minutes after the introduction of a block needle</time_frame>
      <description>Accidental puncture of the common carotid, subclavian, or vertebral artery, pneumo/hemothorax, epidural or intrathecal injection of local anesthetic, local anesthetic systemic toxicity, and other neurological complications</description>
    </other_outcome>
    <other_outcome>
      <measure>Baseline systolic blood pressure</measure>
      <time_frame>5 minutes before the introduction of a block needle</time_frame>
      <description>Measured with a non-invasive blood pressure cuff</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-block systolic blood pressure</measure>
      <time_frame>35 minutes after the introduction of a block needle</time_frame>
      <description>Measured with a non-invasive blood pressure cuff</description>
    </other_outcome>
    <other_outcome>
      <measure>Baseline heart rate</measure>
      <time_frame>5 minutes before the introduction of a block needle</time_frame>
      <description>Measured from electrocardiogram</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-block heart rate</measure>
      <time_frame>35 minutes after the introduction of a block needle</time_frame>
      <description>Measured from electrocardiogram</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">98</enrollment>
    <condition>Brachial Plexus Block</condition>
    <condition>Oximetry</condition>
    <arm_group>
      <arm_group_label>C5-C6 group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The C5-to-C6 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>C5-C8 group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The C5-to-C8 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Interscalene brachial plexus block targeting the C5-to-C6 nerve roots</intervention_name>
      <description>With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C6 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).</description>
      <arm_group_label>C5-C6 group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Interscalene brachial plexus block targeting the C5-to-C8 nerve roots</intervention_name>
      <description>With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C8 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).</description>
      <arm_group_label>C5-C8 group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status 1 or 2&#xD;
  &#xD;
            -  Schedule to receive interscalene brachial plexus block for arthroscopic shoulder&#xD;
               surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Coagulopathy&#xD;
  &#xD;
            -  Peripheral vascular diseases&#xD;
  &#xD;
            -  Arrhythmias&#xD;
  &#xD;
            -  Cardiac conduction abnormalities&#xD;
  &#xD;
            -  A history of medication affecting cardiac conduction&#xD;
  &#xD;
            -  Ischemic heart disease&#xD;
  &#xD;
            -  Hypertension&#xD;
  &#xD;
            -  Diabetes mellitus&#xD;
  &#xD;
            -  Thyroid dysfunction&#xD;
  &#xD;
            -  Other medical conditions affecting autonomic nervous activity&#xD;
  &#xD;
            -  Infection at the skin area for interscalene brachial plexus block&#xD;
  &#xD;
            -  Peripheral neuropathy or neurologic sequelae in the upper limb ipsilateral to the&#xD;
               surgery&#xD;
  &#xD;
            -  Allergy to local anesthetics or a history of allergic shock&#xD;
  &#xD;
            -  Contralateral vocal cord palsy, hemidiaphragmatic paresis/paralysis or pneumo/hemo&#xD;
               thorax&#xD;
  &#xD;
            -  Severe restrictive pulmonary disorder&#xD;
  &#xD;
            -  Electrolyte imbalance&#xD;
  &#xD;
            -  Difficulty in communicating with medical personnel&#xD;
  &#xD;
            -  Patients refusal&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jonghae Kim, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Daegu Catholic University School of Medicine, Daegu, Republic of Korea</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jonghae Kim, M.D.</last_name>
      <phone>+82-10-3360-4885</phone>
      <email>usmed12@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Daegu Catholic University Medical Center</name>
        <address>
          <city>Daegu</city>
          <zip>42472</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jonghae Kim, M.D.</last_name>
        <phone>+82-10-3360-4885</phone>
        <email>usmed12@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Daegu Catholic University Medical Center</investigator_affiliation>
      <investigator_full_name>JongHae Kim</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data will be provided upon reasonable requests to the principal investigator.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015204
  org study id: 2023-02
  nct id: NCT06015204
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to investigate the effectiveness of photoplethysmographic
        amplitude in assessing the extent of anesthesia in the 8th cervical dermatome in patients
        undergoing interscalene brachial plexus block (ISBPB). The main question it aims to answer is
  
          -  Is there any difference in the post-block changes in photoplethysmographic amplitude
             measured from the ipsilateral 5th finger (supplied by the 8th cervical nerve root)
             between ISBPBs targeting the C5-to-C6 nerve roots and the C5-to-C8 nerve roots?
  
          -  Do the changes in photoplethysmographic amplitude represent the extent of anesthesia in
             the 8th cervical dermatome? Participants will receive either ISBPB targeting the
             C5-to-C6 nerve roots or the C5-to-C8 nerve roots, and then the changes in
             photoplethysmographic amplitude will be measured from the 5th finger ipsilateral to
             ISBPB.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 50% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 5% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 10% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 90% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 95% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 99% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 5% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 10% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 50% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 90% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 95% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger
  time frame: 25 minutes after the introduction of a block needle
  description: During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 99% of maximum photoplethysmographic amplitude is achieved, can be derived.
  measure: Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block
  time frame: 15 minutes before the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block
  time frame: 15 minutes before the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block
  time frame: 15 minutes before the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block
  time frame: 25 minutes after the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block
  time frame: 25 minutes after the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block
  time frame: 25 minutes after the introduction of a block needle
  description: The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).
  measure: Sensory blockade of the C5 dermatome
  time frame: 30 minutes after the introduction of a block needle
  description: Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).
  measure: Sensory blockade of the C6 dermatome
  time frame: 30 minutes after the introduction of a block needle
  description: Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).
  measure: Sensory blockade of the C7 dermatome
  time frame: 30 minutes after the introduction of a block needle
  description: Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).
  measure: Sensory blockade of the C8 dermatome
  time frame: 30 minutes after the introduction of a block needle
  description: Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).
  measure: Sensory blockade of the T1 dermatome
  time frame: 30 minutes after the introduction of a block needle
  description: Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).
  measure: Motor blockade of shoulder abduction
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of elbow flexion
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of forearm supination
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of forearm pronation
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of finger abduction
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of thumb abduction
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of thumb adduction
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Motor blockade of thumb opposition
  time frame: 30 minutes after the introduction of a block needle
  description: Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).
  measure: Baseline pupil diameter ipsilateral to interscalene brachial plexus block
  time frame: 5 minutes before the introduction of a block needle
  description: Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.
  measure: Baseline pupil diameter contralateral to interscalene brachial plexus block
  time frame: 5 minutes before the introduction of a block needle
  description: Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.
  measure: Post-block pupil diameter ipsilateral to interscalene brachial plexus block
  time frame: 35 minutes after the introduction of a block needle
  description: Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.
  measure: Post-block pupil diameter contralateral to interscalene brachial plexus block
  time frame: 35 minutes after the introduction of a block needle
  description: Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.
  measure: Pain upon a pinch at the skin area for posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)
  time frame: 1 minute before the surgical incision
  description: The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
  measure: Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)
  time frame: An average of 1 hour after the introduction of a block needle
  description: The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
  measure: Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)
  time frame: 1 minute after surgical incision
  description: The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
  measure: Complications related to interscalene brachial plexus block
  time frame: 35 minutes after the introduction of a block needle
  description: Accidental puncture of the common carotid, subclavian, or vertebral artery, pneumo/hemothorax, epidural or intrathecal injection of local anesthetic, local anesthetic systemic toxicity, and other neurological complications
  measure: Baseline systolic blood pressure
  time frame: 5 minutes before the introduction of a block needle
  description: Measured with a non-invasive blood pressure cuff
  measure: Post-block systolic blood pressure
  time frame: 35 minutes after the introduction of a block needle
  description: Measured with a non-invasive blood pressure cuff
  measure: Baseline heart rate
  time frame: 5 minutes before the introduction of a block needle
  description: Measured from electrocardiogram
  measure: Post-block heart rate
  time frame: 35 minutes after the introduction of a block needle
  description: Measured from electrocardiogram
  arm group label: C5-C6 group
  arm group type: Active Comparator
  description: The C5-to-C6 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.
  arm group label: C5-C8 group
  arm group type: Experimental
  description: The C5-to-C8 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.
  intervention type: Procedure
  intervention name: Interscalene brachial plexus block targeting the C5-to-C6 nerve roots
  description: With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C6 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).
  arm group label: C5-C6 group
  intervention type: Procedure
  intervention name: Interscalene brachial plexus block targeting the C5-to-C8 nerve roots
  description: With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C8 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).
  arm group label: C5-C8 group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jonghae Kim, M.D.
  role: Principal Investigator
  affiliation: Daegu Catholic University School of Medicine, Daegu, Republic of Korea
  last name: Jonghae Kim, M.D.
  phone: +82-10-3360-4885
  email: usmed12@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor-Investigator
  investigator affiliation: Daegu Catholic University Medical Center
  investigator full name: JongHae Kim
  investigator title: Professor
  sharing ipd: No
  ipd description: The data will be provided upon reasonable requests to the principal investigator.