<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/NCT04495868</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000428</org_study_id>
    <nct_id>NCT04495868</nct_id>
  </id_info>
  <brief_title>Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia</brief_title>
  <official_title>Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if creation of a skin wheel with bacteriostatic&#xD;
      normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar&#xD;
      level of anesthesia compared to 1% lidocaine. Participants will receive both types of&#xD;
      anesthesia, in random order.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most chronic pain procedures or injections utilize medications (e.g. local anesthetics) to&#xD;
      numb the skin in an effort to reduce procedure-related pain; however, they can also be a&#xD;
      significant cause of pain leading the patient to abort the procedure. Studies have looked at&#xD;
      alternative medications and techniques that lessen the pain but still provide similar levels&#xD;
      of anesthesia (&quot;numbing&quot;). One such alternative medication is normal saline that includes&#xD;
      benzyl alcohol. Studies researching this specific medication have usually examined procedural&#xD;
      pain related to drawing blood or placing an intravenous (IV) catheter but not for chronic&#xD;
      pain related procedures.&#xD;
&#xD;
      This is a single site randomized double-blinded clinical trial that will compare the standard&#xD;
      of care (1% lidocaine) with bacteriostatic normal saline (saline with benzyl alcohol)&#xD;
      administered as a skin wheal during a diagnostic procedure in patients with chronic low back&#xD;
      pain. The order of administration of the medication will be randomized and the medication&#xD;
      will be blinded to both the subject and the investigator performing the procedure. Skin&#xD;
      wheals will be created with each medication, and the subject's level of pain will be assessed&#xD;
      after each one to measure how painful the creation of the skin wheal was. Then, a spinal&#xD;
      needle for the diagnostic procedure will be placed through the skin wheal and the subject's&#xD;
      level of pain will be assessed after each one to measure the level of anesthesia (or numbing)&#xD;
      that each one provides. The objectives of this study are to determine if administration of&#xD;
      bacteriostatic normal saline causes less discomfort than 1% lidocaine and provides a similar&#xD;
      level of anesthesia/numbing for the procedure.&#xD;
&#xD;
      The study will take place at the Grady Pain clinic and participants will be identified from&#xD;
      patients that are scheduled to undergo a specific low back procedure - diagnostic lumbar&#xD;
      medial branch block. This research study will help identify potential alternatives to the&#xD;
      standard of care for numbing of skin during chronic pain procedures that may reduce&#xD;
      procedure-related pain and discomfort thus making the procedure more tolerable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2021</start_date>
  <completion_date type="Actual">April 6, 2022</completion_date>
  <primary_completion_date type="Actual">April 6, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Needle Placement Pain Score</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin Wheal Pain Score</measure>
    <time_frame>Day 1</time_frame>
    <description>Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Bacteriostatic Normal Saline then 1% Lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1% Lidocaine then Bacteriostatic Normal Saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bacteriostatic Normal Saline</intervention_name>
    <description>A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.</description>
    <arm_group_label>1% Lidocaine then Bacteriostatic Normal Saline</arm_group_label>
    <arm_group_label>Bacteriostatic Normal Saline then 1% Lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1% Lidocaine</intervention_name>
    <description>A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.</description>
    <arm_group_label>1% Lidocaine then Bacteriostatic Normal Saline</arm_group_label>
    <arm_group_label>Bacteriostatic Normal Saline then 1% Lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for an initial lumbar medial branch block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Fibromyalgia&#xD;
&#xD;
          -  Inability to provide informed consent in English&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#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>Brian Bobzien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Pain Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <results_first_submitted>March 28, 2023</results_first_submitted>
  <results_first_submitted_qc>March 28, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 18, 2023</results_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Brian Bobzien</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Local anesthetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data collected during the trial will be available for sharing, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be available for sharing beginning immediately upon publication and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to bbobzie@emory.edu. A link will be provided to the researcher for download of the data.</ipd_access_criteria>
  </patient_data>
  <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>June 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04495868/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bacteriostatic Normal Saline Then 1% Lidocaine</title>
          <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.&#xD;
Bacteriostatic Normal Saline: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.&#xD;
1% Lidocaine: A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.</description>
        </group>
        <group group_id="P2">
          <title>1% Lidocaine Then Bacteriostatic Normal Saline</title>
          <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.&#xD;
Bacteriostatic Normal Saline: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.&#xD;
1% Lidocaine: A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="21"/>
              </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 Normal Saline Then 1% Lidocaine</title>
          <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.</description>
        </group>
        <group group_id="B2">
          <title>1% Lidocaine Then Bacteriostatic Normal Saline</title>
          <description>Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.</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="19"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </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="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </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="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Numerical Pain Rating Scale (NPRS) Score of Back Pain</title>
          <description>The NPRS is an 11-point, self-rated pain scale where participants rate the level of their chronic axial low back pain from 0 (no pain) to 10 (worst pain imaginable).</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8" lower_limit="7" upper_limit="8"/>
                    <measurement group_id="B2" value="8" lower_limit="6" upper_limit="8"/>
                    <measurement group_id="B3" value="8" lower_limit="6" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Needle Placement Pain Score</title>
        <description>Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bacteriostatic Normal Saline</title>
            <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline.</description>
          </group>
          <group group_id="O2">
            <title>1% Lidocaine</title>
            <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% lidocaine.</description>
          </group>
        </group_list>
        <measure>
          <title>Needle Placement Pain Score</title>
          <description>Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skin Wheal Pain Score</title>
        <description>Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bacteriostatic Normal Saline</title>
            <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline.</description>
          </group>
          <group group_id="O2">
            <title>1% Lidocaine</title>
            <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% lidocaine.</description>
          </group>
        </group_list>
        <measure>
          <title>Skin Wheal Pain Score</title>
          <description>Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="4" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Information on adverse events was collected during the lumbar medial branch block procedure (Day 1 of study).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bacteriostatic Normal Saline</title>
          <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline.</description>
        </group>
        <group group_id="E2">
          <title>1% Lidocaine</title>
          <description>Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% 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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </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>Brian Bobzien, MD</name_or_title>
      <organization>Emory University</organization>
      <phone>404-616-4226</phone>
      <email>brian.patrick.bobzien@emory.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/NCT04495868
org study id: STUDY00000428
nct id: NCT04495868
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if creation of a skin wheel with bacteriostatic
      normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar
      level of anesthesia compared to 1% lidocaine. Participants will receive both types of
      anesthesia, in random order.
Most chronic pain procedures or injections utilize medications (e.g. local anesthetics) to
      numb the skin in an effort to reduce procedure-related pain; however, they can also be a
      significant cause of pain leading the patient to abort the procedure. Studies have looked at
      alternative medications and techniques that lessen the pain but still provide similar levels
      of anesthesia ("numbing"). One such alternative medication is normal saline that includes
      benzyl alcohol. Studies researching this specific medication have usually examined procedural
      pain related to drawing blood or placing an intravenous (IV) catheter but not for chronic
      pain related procedures.

      This is a single site randomized double-blinded clinical trial that will compare the standard
      of care (1% lidocaine) with bacteriostatic normal saline (saline with benzyl alcohol)
      administered as a skin wheal during a diagnostic procedure in patients with chronic low back
      pain. The order of administration of the medication will be randomized and the medication
      will be blinded to both the subject and the investigator performing the procedure. Skin
      wheals will be created with each medication, and the subject's level of pain will be assessed
      after each one to measure how painful the creation of the skin wheal was. Then, a spinal
      needle for the diagnostic procedure will be placed through the skin wheal and the subject's
      level of pain will be assessed after each one to measure the level of anesthesia (or numbing)
      that each one provides. The objectives of this study are to determine if administration of
      bacteriostatic normal saline causes less discomfort than 1% lidocaine and provides a similar
      level of anesthesia/numbing for the procedure.

      The study will take place at the Grady Pain clinic and participants will be identified from
      patients that are scheduled to undergo a specific low back procedure - diagnostic lumbar
      medial branch block. This research study will help identify potential alternatives to the
      standard of care for numbing of skin during chronic pain procedures that may reduce
      procedure-related pain and discomfort thus making the procedure more tolerable.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Needle Placement Pain Score
time frame: Day 1
description: Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
measure: Skin Wheal Pain Score
time frame: Day 1
description: Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
arm group label: Bacteriostatic Normal Saline then 1% Lidocaine
arm group type: Experimental
description: Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
arm group label: 1% Lidocaine then Bacteriostatic Normal Saline
arm group type: Active Comparator
description: Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
intervention type: Drug
intervention name: Bacteriostatic Normal Saline
description: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
arm group label: 1% Lidocaine then Bacteriostatic Normal Saline
arm group label: Bacteriostatic Normal Saline then 1% Lidocaine
intervention type: Drug
intervention name: 1% Lidocaine
description: A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
arm group label: 1% Lidocaine then Bacteriostatic Normal Saline
arm group label: Bacteriostatic Normal Saline then 1% Lidocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Bobzien, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Brian Bobzien
investigator title: Assistant Professor
mesh term: Chronic Pain
mesh term: Lidocaine
sharing ipd: Yes
ipd description: Individual participant data collected during the trial will be available for sharing, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Data will be available for sharing beginning immediately upon publication and ending 36 months following article publication.
ipd access criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to bbobzie@emory.edu. A link will be provided to the researcher for download of the data.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 