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/NCT06005480</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001767</org_study_id>
      <nct_id>NCT06005480</nct_id>
    </id_info>
    <brief_title>Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers</brief_title>
    <official_title>Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Regional anesthesia decreases postoperative pain scores and opioid consumption, and may&#xD;
        prevent chronic pain after surgery in patients undergoing surgery. However, some patients&#xD;
        experience an increase of pain into the severe range when the nerve block wears off, also&#xD;
        known as rebound pain. The investigators are studying if a nerve block (numbing injection) in&#xD;
        the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, randomized study in healthy volunteers who will undergo sensory&#xD;
        testing using quantitative sensory testing (QST), complete psychosocial and pain&#xD;
        questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve&#xD;
        block) in a supervised, monitored setting (BWH Clinical Investigation Center). The&#xD;
        investigators plan to assess the association between different QST modalities at different&#xD;
        time points pre- and post-nerve block resolution. Semi-structured interviews and qualitative&#xD;
        analysis will be used to explore patient's experiences with nerve block placement.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <phase>Phase 1</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>Participants will be randomized to which arm will receive a nerve block.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heat pain detection threshold at time 1 hr</measure>
      <time_frame>1 hour after nerve block resolution</time_frame>
      <description>Heat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heat pain detection threshold and tolerance</measure>
      <time_frame>0-3 hours after nerve block resolution</time_frame>
      <description>Heat pain detection threshold and tolerance (°C) between block arm and control arm using a heat probe at different time points up to 3 hours nerve block resolution</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pressure pain threshold and tolerance</measure>
      <time_frame>0-3 hours after nerve block resolution</time_frame>
      <description>Pressure pain threshold and tolerance (N of force) between block arm and control arm using an algometer at different time points up to 3 hours nerve block resolution</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Temporal summation and sharp pain</measure>
      <time_frame>0-3 hours after nerve block resolution</time_frame>
      <description>Temporal summation and sharp pain (evaluated by numerical rating scale 0-10 pain score) between block arm and control arm using a pinprick device at different time points up to 3 hours nerve block</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Light touch detection</measure>
      <time_frame>0-3 hours after nerve block resolution</time_frame>
      <description>Light touch detection (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Light touch pain threshold</measure>
      <time_frame>0-3 hours after nerve block resolution</time_frame>
      <description>Light touch pain threshold (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Temperature change</measure>
      <time_frame>6-8 hours</time_frame>
      <description>To observe the change in temperature between block arm and control arm (°C) pre, during, and post nerve block</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient's experiences with nerve block</measure>
      <time_frame>6-8 hours</time_frame>
      <description>Semi-structured interviews will be used to explore patient's experiences with nerve block placement using an immersion/crystallization approach to identify emergent themes</description>
    </other_outcome>
    <other_outcome>
      <measure>Pain catastrophizing and gender differences</measure>
      <time_frame>6-8 hours</time_frame>
      <description>Correlation between situational pain catastrophizing (0-24 scale) and gender</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Regional Anesthesia Morbidity</condition>
    <condition>Pain, Acute</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Block upper extremity (arm)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Upper extremity with a nerve block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control upper extremity (arm)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Upper extremity without a nerve block</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mepivacaine</intervention_name>
      <description>Injection of 1.5% Mepivacaine in nerve block</description>
      <arm_group_label>Block upper extremity (arm)</arm_group_label>
      <other_name>Prilocaine</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old, ≤ 65 years old&#xD;
  &#xD;
            -  BMI &gt;18, &lt; 35&#xD;
  &#xD;
            -  Able to speak and understand English&#xD;
  &#xD;
            -  Willingness to undergo psychophysical testing (e.g., QST, pain questionnaires)&#xD;
  &#xD;
            -  Willingness to have nerve block performed&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ongoing acute or chronic pain in upper extremities&#xD;
  &#xD;
            -  Skin or tissue infection affecting upper extremities&#xD;
  &#xD;
            -  Previous hypersensitivity to mepivacaine or lidocaine&#xD;
  &#xD;
            -  Previous neuropathy (numbness, paresthesia, or motor weakness) in either upper&#xD;
               extremity&#xD;
  &#xD;
            -  Loss of any limb&#xD;
  &#xD;
            -  Bleeding issues or bleeding disorder&#xD;
  &#xD;
            -  History of alcohol or drug abuse&#xD;
  &#xD;
            -  Currently pregnant or breastfeeding&#xD;
  &#xD;
            -  History of seizure or epilepsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yun-Yun K Chen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Brigham and Women's Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yun-Yun K Chen, MD</last_name>
      <phone>6176510932</phone>
      <email>ykchen@mgb.org</email>
    </overall_contact>
    <link>
      <url>https://rally.massgeneralbrigham.org/study/rebound_pain_nerve_block</url>
      <description>Mass General Brigham Rally Flyer</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Yun-Yun K. Chen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Healthy volunteer</keyword>
    <keyword>Regional anesthesia</keyword>
    <keyword>Rebound pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prilocaine</mesh_term>
      <mesh_term>Mepivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06005480
  org study id: 2023P001767
  nct id: NCT06005480
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Regional anesthesia decreases postoperative pain scores and opioid consumption, and may
        prevent chronic pain after surgery in patients undergoing surgery. However, some patients
        experience an increase of pain into the severe range when the nerve block wears off, also
        known as rebound pain. The investigators are studying if a nerve block (numbing injection) in
        the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.
  This is a prospective, randomized study in healthy volunteers who will undergo sensory
        testing using quantitative sensory testing (QST), complete psychosocial and pain
        questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve
        block) in a supervised, monitored setting (BWH Clinical Investigation Center). The
        investigators plan to assess the association between different QST modalities at different
        time points pre- and post-nerve block resolution. Semi-structured interviews and qualitative
        analysis will be used to explore patient's experiences with nerve block placement.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to which arm will receive a nerve block.
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Heat pain detection threshold at time 1 hr
  time frame: 1 hour after nerve block resolution
  description: Heat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution
  measure: Heat pain detection threshold and tolerance
  time frame: 0-3 hours after nerve block resolution
  description: Heat pain detection threshold and tolerance (°C) between block arm and control arm using a heat probe at different time points up to 3 hours nerve block resolution
  measure: Pressure pain threshold and tolerance
  time frame: 0-3 hours after nerve block resolution
  description: Pressure pain threshold and tolerance (N of force) between block arm and control arm using an algometer at different time points up to 3 hours nerve block resolution
  measure: Temporal summation and sharp pain
  time frame: 0-3 hours after nerve block resolution
  description: Temporal summation and sharp pain (evaluated by numerical rating scale 0-10 pain score) between block arm and control arm using a pinprick device at different time points up to 3 hours nerve block
  measure: Light touch detection
  time frame: 0-3 hours after nerve block resolution
  description: Light touch detection (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block
  measure: Light touch pain threshold
  time frame: 0-3 hours after nerve block resolution
  description: Light touch pain threshold (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block
  measure: Temperature change
  time frame: 6-8 hours
  description: To observe the change in temperature between block arm and control arm (°C) pre, during, and post nerve block
  measure: Patient's experiences with nerve block
  time frame: 6-8 hours
  description: Semi-structured interviews will be used to explore patient's experiences with nerve block placement using an immersion/crystallization approach to identify emergent themes
  measure: Pain catastrophizing and gender differences
  time frame: 6-8 hours
  description: Correlation between situational pain catastrophizing (0-24 scale) and gender
  arm group label: Block upper extremity (arm)
  arm group type: Experimental
  description: Upper extremity with a nerve block
  arm group label: Control upper extremity (arm)
  arm group type: No Intervention
  description: Upper extremity without a nerve block
  intervention type: Drug
  intervention name: Mepivacaine
  description: Injection of 1.5% Mepivacaine in nerve block
  arm group label: Block upper extremity (arm)
  other name: Prilocaine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yun-Yun K Chen, MD
  role: Principal Investigator
  affiliation: Brigham and Women's Hospital
  last name: Yun-Yun K Chen, MD
  phone: 6176510932
  email: ykchen@mgb.org
  url: https://rally.massgeneralbrigham.org/study/rebound_pain_nerve_block
  description: Mass General Brigham Rally Flyer
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Yun-Yun K. Chen
  investigator title: Principal Investigator
  mesh term: Acute Pain
  mesh term: Prilocaine
  mesh term: Mepivacaine
  sharing ipd: No