<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/NCT02209272</url>
  </required_header>
  <id_info>
    <org_study_id>14-002622</org_study_id>
    <nct_id>NCT02209272</nct_id>
  </id_info>
  <brief_title>Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia</brief_title>
  <official_title>Local Anesthesia for Ultrasound Guided Hip Joint Injections: A Double-Blinded Randomized Controlled Trial of Bacteriostatic Saline Versus Buffered Lidocaine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare infiltration pain and anesthetic efficacy between&#xD;
      lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip&#xD;
      injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Local anesthesia is commonly used to reduce pain during joint injections, particularly for&#xD;
      deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most&#xD;
      medical practices. It is well known that lidocaine infiltration itself is painful. Many&#xD;
      strategies have been studied to minimize pain associated with lidocaine administration,&#xD;
      including buffering, warming, and slowing infiltration rate. BS is an alternative local&#xD;
      anesthetic that has been shown to be less painful when injected into subcutaneous tissues&#xD;
      compared with lidocaine. However, BS use has not been widely implemented for local&#xD;
      anesthesia, and it has not been studied in the context of joint injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS for Pain Score During Local Anesthesia Infiltration</measure>
    <time_frame>baseline to 5-10 minutes later -- immediately after local anesthetic injection administration</time_frame>
    <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)</measure>
    <time_frame>baseline to 5-10 minutes later -- immediately after hip joint injection</time_frame>
    <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthetic Infiltration Duration</measure>
    <time_frame>baseline</time_frame>
    <description>Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Hip Pain</condition>
  <arm_group>
    <arm_group_label>bacteriostatic saline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>for ultrasound guided hip joint injection local anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>buffered lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>for ultrasound guided hip joint injection local anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bacteriostatic saline</intervention_name>
    <arm_group_label>bacteriostatic saline</arm_group_label>
    <other_name>0.9% benzyl alcohol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>buffered lidocaine</intervention_name>
    <arm_group_label>buffered lidocaine</arm_group_label>
    <other_name>1% lidocaine combined (9:1) with sodium bicarbonate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  age 18-75 years&#xD;
&#xD;
          -  referred for US-guided intraarticular hip injections in the Mayo Clinic Sports&#xD;
             Medicine Center, Physical Medicine &amp; Rehabilitation Clinic, or Musculoskeletal Clinic&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  chronic opioid use&#xD;
&#xD;
          -  opioid use on day of procedure&#xD;
&#xD;
          -  history of fibromyalgia or other diffuse chronic pain syndrome&#xD;
&#xD;
          -  pain behavior during the clinical encounter as judged by the injectionist&#xD;
&#xD;
          -  anesthetic administration time outside the designated 5-15 second time frame&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacob Sellon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>March 4, 2019</results_first_submitted>
  <results_first_submitted_qc>March 4, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2019</results_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Jacob L. Sellon, M.D.</investigator_full_name>
    <investigator_title>Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Benzyl Alcohol</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02209272/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bacteriostatic Saline</title>
          <description>In this arm patients received 2 injections:&#xD;
one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle&#xD;
a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle&#xD;
VAS-pain scores were collected immediately after each injection.</description>
        </group>
        <group group_id="P2">
          <title>Buffered Lidocaine</title>
          <description>In this arm patients received 2 injections:&#xD;
one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle&#xD;
a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle&#xD;
VAS-pain scores were collected immediately after each injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="36"/>
              </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>Bacteriostatic Saline</title>
          <description>In this arm patients received 2 injections:&#xD;
one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle&#xD;
a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle&#xD;
VAS-pain scores were collected immediately after each injection.</description>
        </group>
        <group group_id="B2">
          <title>Buffered Lidocaine</title>
          <description>In this arm patients received 2 injections:&#xD;
one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle&#xD;
a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle&#xD;
VAS-pain scores were collected immediately after each injection.</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="32"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.2" spread="16"/>
                    <measurement group_id="B2" value="55.6" spread="16.1"/>
                    <measurement group_id="B3" value="54.9" spread="16"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="32"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>VAS for Pain Score During Local Anesthesia Infiltration</title>
        <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
        <time_frame>baseline to 5-10 minutes later -- immediately after local anesthetic injection administration</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bacteriostatic Saline</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
bacteriostatic saline</description>
          </group>
          <group group_id="O2">
            <title>Buffered Lidocaine</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
buffered lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>VAS for Pain Score During Local Anesthesia Infiltration</title>
          <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="15"/>
                    <measurement group_id="O2" value="14" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.82</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)</title>
        <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
        <time_frame>baseline to 5-10 minutes later -- immediately after hip joint injection</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bacteriostatic Saline</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
bacteriostatic saline</description>
          </group>
          <group group_id="O2">
            <title>Buffered Lidocaine</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
buffered lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)</title>
          <description>The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; (score of 100).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="18.4"/>
                    <measurement group_id="O2" value="15.6" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.21</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anesthetic Infiltration Duration</title>
        <description>Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.</description>
        <time_frame>baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bacteriostatic Saline</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
bacteriostatic saline</description>
          </group>
          <group group_id="O2">
            <title>Buffered Lidocaine</title>
            <description>for ultrasound guided hip joint injection local anesthesia&#xD;
buffered lidocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Anesthetic Infiltration Duration</title>
          <description>Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" spread="4.5"/>
                    <measurement group_id="O2" value="32.7" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.57</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study treatment follow-up period is defined as two weeks post-procedure.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bacteriostatic Saline</title>
          <description>for ultrasound guided hip joint injection local anesthesia&#xD;
bacteriostatic saline</description>
        </group>
        <group group_id="E2">
          <title>Buffered Lidocaine</title>
          <description>for ultrasound guided hip joint injection local anesthesia&#xD;
buffered lidocaine</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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </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="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Jacob L. Sellon</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2608</phone>
      <email>sellon.jacob@mayo.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/NCT02209272
org study id: 14-002622
nct id: NCT02209272
lead sponsor: 
has dmc: No
The purpose of this study is to compare infiltration pain and anesthetic efficacy between
      lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip
      injections.
Local anesthesia is commonly used to reduce pain during joint injections, particularly for
      deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most
      medical practices. It is well known that lidocaine infiltration itself is painful. Many
      strategies have been studied to minimize pain associated with lidocaine administration,
      including buffering, warming, and slowing infiltration rate. BS is an alternative local
      anesthetic that has been shown to be less painful when injected into subcutaneous tissues
      compared with lidocaine. However, BS use has not been widely implemented for local
      anesthesia, and it has not been studied in the context of joint injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: VAS for Pain Score During Local Anesthesia Infiltration
time frame: baseline to 5-10 minutes later -- immediately after local anesthetic injection administration
description: The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).
measure: VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)
time frame: baseline to 5-10 minutes later -- immediately after hip joint injection
description: The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).
measure: Anesthetic Infiltration Duration
time frame: baseline
description: Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.
arm group label: bacteriostatic saline
arm group type: Experimental
description: for ultrasound guided hip joint injection local anesthesia
arm group label: buffered lidocaine
arm group type: Active Comparator
description: for ultrasound guided hip joint injection local anesthesia
intervention type: Drug
intervention name: bacteriostatic saline
arm group label: bacteriostatic saline
other name: 0.9% benzyl alcohol
intervention type: Drug
intervention name: buffered lidocaine
arm group label: buffered lidocaine
other name: 1% lidocaine combined (9:1) with sodium bicarbonate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob Sellon, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Jacob L. Sellon, M.D.
investigator title: Assistant Professor of Physical Medicine and Rehabilitation, Sports Medicine Center
mesh term: Lidocaine
mesh term: Benzyl Alcohol
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 