<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/NCT02186795</url>
  </required_header>
  <id_info>
    <org_study_id>THA Retrospective Analysis</org_study_id>
    <nct_id>NCT02186795</nct_id>
  </id_info>
  <brief_title>Total Hip Arthroplasty Outcomes With Regional and Multimodal Analgesia</brief_title>
  <acronym>THA</acronym>
  <official_title>Improvement in Total Hip Arthroplasty Patient Outcomes With Regional Anesthesia and Multimodal Analgesia: A Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this retrospective chart review is to evaluate if the implementation of lumbar&#xD;
      plexus block placement for postoperative pain and administration of multimodal oral analgesia&#xD;
      have improved conditions in the postoperative period for patients undergoing total hip&#xD;
      arthroplasty when compared to the placement of epidurals for postoperative pain management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome:&#xD;
      Time to first ambulation, assitstance needed with ambulation, opiate and regional related&#xD;
      side effects, time to discharge orders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Opiate Consumption</measure>
    <time_frame>48 hours postoperative</time_frame>
    <description>Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">117</enrollment>
  <condition>Arthroplasty</condition>
  <condition>Replacement, Hip</condition>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Lumbar plexus</arm_group_label>
    <description>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lumbar Epidural</arm_group_label>
    <description>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing primary total hip arthroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary total hip arthroplasty, (identified by current procedural terminology (CPT)&#xD;
             code 27130) and&#xD;
&#xD;
          2. Either a) Epidural or b) Lumbar plexus peripheral nerve block with the administration&#xD;
             of multimodal medication after July 2012.&#xD;
&#xD;
             -&#xD;
&#xD;
             Exclusion Criteria:Exclusion criteria include THA Revision, ICU admission&#xD;
             postoperatively, and dementia, not allowing pain score communication.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvia Wilson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>June 4, 2018</results_first_submitted>
  <results_first_submitted_qc>December 19, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2019</results_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Sylvia Wilson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Arthroplasty</keyword>
  <keyword>Replacement, Hip</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Inclusion criteria consisted of primary elective THA surgery with either (1) a lumbar epidural (n = 51) or (2) a lumbar plexus peripheral nerve block (n = 312) for postoperative analgaesia. Exclusion criteria were THA revision, traumatic fractures, nonelective surgery, general anaesthesia, and post-operative intensive care unit (ICU) admission.</recruitment_details>
      <pre_assignment_details>Of the charts reviewed, 31 lumbar epidural and 153 lumbar plexus patients met inclusion criteria and were assigned a chronological number based on the date of their operation (Epidural 1-31; Lumbar plexus 1-153). These numbered lists were then randomised and data collected on the first 24 randomised patients for each block type.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lumbar Plexus</title>
          <description>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.</description>
        </group>
        <group group_id="P2">
          <title>Lumbar Epidural</title>
          <description>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lumbar Plexus</title>
          <description>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.</description>
        </group>
        <group group_id="B2">
          <title>Lumbar Epidural</title>
          <description>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="2.32"/>
                    <measurement group_id="B2" value="61.2" spread="2.55"/>
                    <measurement group_id="B3" value="61.65" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Opiate Consumption</title>
        <description>Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)</description>
        <time_frame>48 hours postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus</title>
            <description>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.</description>
          </group>
          <group group_id="O2">
            <title>Lumbar Epidural</title>
            <description>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.</description>
          </group>
        </group_list>
        <measure>
          <title>Opiate Consumption</title>
          <description>Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)</description>
          <units>IV MME</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.6" spread="5.21"/>
                    <measurement group_id="O2" value="53.9" spread="6.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>48 hours after surgery or hospital discharge, whichever came first.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lumbar Plexus</title>
          <description>Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.</description>
        </group>
        <group group_id="E2">
          <title>Lumbar Epidural</title>
          <description>Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sylvia Wilson, MD</name_or_title>
      <organization>MUSC</organization>
      <phone>843-732-2322</phone>
      <email>wilsosh@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02186795
org study id: THA Retrospective Analysis
nct id: NCT02186795
lead sponsor: 
has dmc: No
The goal of this retrospective chart review is to evaluate if the implementation of lumbar
      plexus block placement for postoperative pain and administration of multimodal oral analgesia
      have improved conditions in the postoperative period for patients undergoing total hip
      arthroplasty when compared to the placement of epidurals for postoperative pain management.
Primary outcome: 48 hour opiate consumption in patients following THA. ' Secondary outcome:
      Time to first ambulation, assitstance needed with ambulation, opiate and regional related
      side effects, time to discharge orders.
observational model: Case-Control
time perspective: Retrospective
measure: Opiate Consumption
time frame: 48 hours postoperative
description: Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)
arm group label: Lumbar plexus
description: Patients received a preoperative lumbar plexus nerve block (20 ml, ropivacaine 0.5%) for postoperative pain management with one to four multimodal oral pain medications (acetaminophen, celecoxib, oxycodone ER, gabapentin, pregabalin) administered preoperatively or in the first 48 hours postoperatively.
arm group label: Lumbar Epidural
description: Patients received a lumbar epidural preoperatively for postoperative pain management. Epidural infusions of ropivacaine 0.2% were initiated intraoperatively, administered until the morning of postoperative day 1, and titrated to patient comfort.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvia Wilson, M.D.
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Sylvia Wilson
investigator title: Assistant Professor
mesh term: Arthritis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 