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/NCT06042322</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000514</org_study_id>
      <nct_id>NCT06042322</nct_id>
    </id_info>
    <brief_title>Retrospective Analysis of Pain After Nerve Block in Surgical Patients</brief_title>
    <official_title>Retrospective Analysis of Pain in Patients Who Receive a Nerve Block for Surgery</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a retrospective study looking at patients who received a nerve block for surgery and&#xD;
        assessing pain after the nerve block resolves, with or without an educational intervention,&#xD;
        over two periods of time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Regional anesthesia (RA) is a vital tool that can serve as the primary anesthetic or as part&#xD;
        of a multimodal perioperative pain regimen. RA is strongly associated with decreased acute&#xD;
        and persistent pain and opioid consumption postoperatively. However, some patients experience&#xD;
        an acute worsening of pain into the severe range around the time of RA resolution, also known&#xD;
        as &quot;rebound pain&quot; (RP). The incidence of RP has been reported as high as 40-50% after a&#xD;
        single shot nerve block for patients undergoing ambulatory surgery.&#xD;
  &#xD;
        This retrospective study aims to look at patients who received a nerve block for surgery and&#xD;
        assessing pain after the nerve block resolves in the presence and absence of certain&#xD;
        interventions, such as a multidisciplinary educational intervention.&#xD;
  &#xD;
        The investigators will assess patients who received a primary total knee arthroplasty who&#xD;
        received a single shot adductor canal nerve block, received pericapsular injection by the&#xD;
        surgeon, and had a length of stay &gt; 16 hours.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">January 1, 2017</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall pain score</measure>
      <time_frame>8-16 hours</time_frame>
      <description>Difference in area under the curve of pain scores, numerical pain rating scale 0-10, 8-16 hours after nerve block between the two cohorts (educational intervention and non-educational intervention time periods)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Difference in maximum pain score post-nerve block</measure>
      <time_frame>8-16 hours</time_frame>
      <description>Difference in maximum pain score, numerical pain rating scale 0-10, 8-16 hours after nerve block between the two cohorts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference in incidence of rebound pain</measure>
      <time_frame>8-16 hours</time_frame>
      <description>Difference in incidence pain score ≥ 7 between 8-16 hours post nerve block between the two cohorts</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Comparison of evening opioids given</measure>
      <time_frame>8-16 hours</time_frame>
      <description>Comparison of if evening opioids were or were not given (yes/no) between the two cohorts</description>
    </other_outcome>
    <other_outcome>
      <measure>Difference in total opioids given</measure>
      <time_frame>8-16 hours</time_frame>
      <description>Difference in total opioids given (mEq of morphine) between the two cohorts</description>
    </other_outcome>
    <other_outcome>
      <measure>Difference in length of stay</measure>
      <time_frame>0-30 days</time_frame>
      <description>Difference in length of stay (days) between the two cohorts</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">166</enrollment>
    <condition>Regional Anesthesia Morbidity</condition>
    <condition>Acute Pain</condition>
    <condition>Knee Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>TKA with nerve block no intervention</arm_group_label>
      <description>Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery January 2017-December 2017</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TKA with nerve block with intervention</arm_group_label>
      <description>Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery during March 2019-March 2020, and received an educational intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Educational intervention</intervention_name>
      <description>Multidisciplinary educational intervention was performed by orthopedic, anesthesia, and nursing team. This included a discussion of the patient's pain plan and a patient visit.</description>
      <arm_group_label>TKA with nerve block with intervention</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Using the Mass General Brigham Enterprise Data Warehouse, electronic health record data&#xD;
          will be retrieved: adult patients, 18 years of age or older, who received a primary total&#xD;
          knee arthroplasty, an adductor canal nerve block, pericapsular injection, and admitted to&#xD;
          stay overnight (&gt;16 hours post nerve block).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  primary total knee arthroplasty&#xD;
  &#xD;
            -  received an adductor canal nerve block&#xD;
  &#xD;
            -  received pericapsular injection by surgeon intraoperatively&#xD;
  &#xD;
            -  admitted for overnight stay and &gt; 16 hours post-nerve block&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  age &lt; 18&#xD;
  &#xD;
            -  prior total knee arthroplasty on ipsilateral knee&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </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>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <!-- 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/NCT06042322
  org study id: 2023P000514
  nct id: NCT06042322
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a retrospective study looking at patients who received a nerve block for surgery and
        assessing pain after the nerve block resolves, with or without an educational intervention,
        over two periods of time.
  Regional anesthesia (RA) is a vital tool that can serve as the primary anesthetic or as part
        of a multimodal perioperative pain regimen. RA is strongly associated with decreased acute
        and persistent pain and opioid consumption postoperatively. However, some patients experience
        an acute worsening of pain into the severe range around the time of RA resolution, also known
        as "rebound pain" (RP). The incidence of RP has been reported as high as 40-50% after a
        single shot nerve block for patients undergoing ambulatory surgery.
  
        This retrospective study aims to look at patients who received a nerve block for surgery and
        assessing pain after the nerve block resolves in the presence and absence of certain
        interventions, such as a multidisciplinary educational intervention.
  
        The investigators will assess patients who received a primary total knee arthroplasty who
        received a single shot adductor canal nerve block, received pericapsular injection by the
        surgeon, and had a length of stay > 16 hours.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall pain score
  time frame: 8-16 hours
  description: Difference in area under the curve of pain scores, numerical pain rating scale 0-10, 8-16 hours after nerve block between the two cohorts (educational intervention and non-educational intervention time periods)
  measure: Difference in maximum pain score post-nerve block
  time frame: 8-16 hours
  description: Difference in maximum pain score, numerical pain rating scale 0-10, 8-16 hours after nerve block between the two cohorts
  measure: Difference in incidence of rebound pain
  time frame: 8-16 hours
  description: Difference in incidence pain score ≥ 7 between 8-16 hours post nerve block between the two cohorts
  measure: Comparison of evening opioids given
  time frame: 8-16 hours
  description: Comparison of if evening opioids were or were not given (yes/no) between the two cohorts
  measure: Difference in total opioids given
  time frame: 8-16 hours
  description: Difference in total opioids given (mEq of morphine) between the two cohorts
  measure: Difference in length of stay
  time frame: 0-30 days
  description: Difference in length of stay (days) between the two cohorts
  arm group label: TKA with nerve block no intervention
  description: Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery January 2017-December 2017
  arm group label: TKA with nerve block with intervention
  description: Patients who received a single shot adductor canal nerve block prior to total knee arthroplasty surgery during March 2019-March 2020, and received an educational intervention
  intervention type: Other
  intervention name: Educational intervention
  description: Multidisciplinary educational intervention was performed by orthopedic, anesthesia, and nursing team. This included a discussion of the patient's pain plan and a patient visit.
  arm group label: TKA with nerve block with intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Yun-Yun K Chen, MD
  role: Principal Investigator
  affiliation: Brigham and Women's Hospital
  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