<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/NCT03244631</url>
  </required_header>
  <id_info>
    <org_study_id>20171307</org_study_id>
    <nct_id>NCT03244631</nct_id>
  </id_info>
  <brief_title>Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection</brief_title>
  <official_title>Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington Orthopaedics and Sports Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington Orthopaedics and Sports Medicine</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>
      Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during&#xD;
      hip arthroscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare two different methods of pain control during and&#xD;
      after hip arthroscopy surgery. It is not clear which of many different pain control methods&#xD;
      are ideal to reduce pain for patients; consequently, the investigators are performing this&#xD;
      study to compare the two main choices for pain control commonly used in order to identify if&#xD;
      either is superior to the other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</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>
    <intervention_model_description>Prospective randomized</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>At the one hour point in the PACU</time_frame>
    <description>Compare post-operative pain scores in the immediate post-operative period as defined by visual-analog pain scale at the time point of one hour spent in the post-anesthesia care unit (PACU).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine equivalents</measure>
    <time_frame>At the two hour point in the PACU</time_frame>
    <description>Compare the total morphine equivalents of opioids provided in the PACU within the first two hours of time spent in the PACU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in PACU</measure>
    <time_frame>Immediately after surgery</time_frame>
    <description>Compare the overall time spent in the PACU as defined by time to arrival to time to discharge vitals.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Nerve Block</condition>
  <condition>Hip Arthroscopy</condition>
  <arm_group>
    <arm_group_label>Lumbar Plexus Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A lumbar plexus 'nerve block' is a procedure in which local anesthetic (&quot;numbing medicine&quot;) is injected around a specific group of nerves to provide pain relief directly to the nerves supplying the area of the body undergoing surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pericapsular Injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The pericapsular injection is a procedure in which local anesthetic (&quot;numbing medicine&quot;) is injected around the hip joint to provide direct pain relief to the area undergoing surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar Plexus BLock</intervention_name>
    <description>Peripheral nerve block</description>
    <arm_group_label>Lumbar Plexus Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pericapsular injection</intervention_name>
    <description>Injection around the area undergoing surgery</description>
    <arm_group_label>Pericapsular Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient scheduled to undergo hip arthroscopy with Dr. Wolff&#xD;
&#xD;
          2. Patient age between 25 and 60 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has known allergy to ropivicaine or morphine.&#xD;
&#xD;
          2. Patient unable to speak/read English (No translators available in clinic site).&#xD;
&#xD;
          3. Pregnant female.&#xD;
&#xD;
          4. Patient has a pre-operative narcotic use for hip pain&#xD;
&#xD;
          5. Patient has pre-existing chronic pain disorder (i.e. fibromyalgia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Wolff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington Orthopaedics and Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington Orthopedics and Sports Medicine</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington Orthopaedics and Sports Medicine</investigator_affiliation>
    <investigator_full_name>Andrew B. Wolff, MD</investigator_full_name>
    <investigator_title>Attending Surgeon</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244631
org study id: 20171307
nct id: NCT03244631
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during
      hip arthroscopy
The purpose of this study is to compare two different methods of pain control during and
      after hip arthroscopy surgery. It is not clear which of many different pain control methods
      are ideal to reduce pain for patients; consequently, the investigators are performing this
      study to compare the two main choices for pain control commonly used in order to identify if
      either is superior to the other.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Pain score
time frame: At the one hour point in the PACU
description: Compare post-operative pain scores in the immediate post-operative period as defined by visual-analog pain scale at the time point of one hour spent in the post-anesthesia care unit (PACU).
measure: Morphine equivalents
time frame: At the two hour point in the PACU
description: Compare the total morphine equivalents of opioids provided in the PACU within the first two hours of time spent in the PACU
measure: Time spent in PACU
time frame: Immediately after surgery
description: Compare the overall time spent in the PACU as defined by time to arrival to time to discharge vitals.
arm group label: Lumbar Plexus Block
arm group type: Active Comparator
description: A lumbar plexus 'nerve block' is a procedure in which local anesthetic ("numbing medicine") is injected around a specific group of nerves to provide pain relief directly to the nerves supplying the area of the body undergoing surgery.
arm group label: Pericapsular Injection
arm group type: Active Comparator
description: The pericapsular injection is a procedure in which local anesthetic ("numbing medicine") is injected around the hip joint to provide direct pain relief to the area undergoing surgery.
intervention type: Procedure
intervention name: Lumbar Plexus BLock
description: Peripheral nerve block
arm group label: Lumbar Plexus Block
intervention type: Procedure
intervention name: Pericapsular injection
description: Injection around the area undergoing surgery
arm group label: Pericapsular Injection
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Wolff, MD
role: Principal Investigator
affiliation: Washington Orthopaedics and Sports Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Washington Orthopaedics and Sports Medicine
investigator full name: Andrew B. Wolff, MD
investigator title: Attending Surgeon
sharing ipd: No