<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/NCT01719237</url>
  </required_header>
  <id_info>
    <org_study_id>ChloroRopiSCB</org_study_id>
    <nct_id>NCT01719237</nct_id>
  </id_info>
  <brief_title>Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture</brief_title>
  <official_title>Double Blinded Randomized Control Trial Comparing the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using Ropivacaine Versus Ropivacaine-Chloroprocaine Mixture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double blinded randomized controlled trial comparing the onset and duration of the Onset&#xD;
      and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local&#xD;
      anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic&#xD;
      (Ropivacaine-Chloroprocaine Mixture).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be met preoperatively in the pre-anesthesia holding area as is typical for most&#xD;
      orthopedic procedures. An attending anesthesiologist will evaluate the patient and planned&#xD;
      surgical procedure and determine if the best anesthetic plan includes a supraclavicular&#xD;
      brachial plexus block and will ensure that the patient provides informed consent for their&#xD;
      anesthetic plan. Patients who will be having a supraclavicular brachial plexus block as part&#xD;
      of their anesthetic will be approached for possible inclusion in the study.&#xD;
&#xD;
      The patient's surgical site will be verified by standard time out procedure. Standard&#xD;
      monitoring will be placed including pulse oximetry, EKG, and non-invasive blood pressure&#xD;
      cuff. A nasal canula will be placed to provide oxygen. The patient may be given midazolam IV&#xD;
      up to 0.05 mg/kg as needed for anxiolysis. The supraclavicular brachial plexus block will be&#xD;
      performed by either the attending anesthesiologist or a resident physician directly&#xD;
      supervised by the attending anesthesiologist using ultrasound guidance.&#xD;
&#xD;
      The randomization envelope will be handed to an anesthesiologist not involved in the&#xD;
      patient's care who will fill a 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's&#xD;
      of normal saline + 0.1 ml of 1mg/ml epinephrine or 20 ml's of 1% ropivacaine + 10 ml's of 3%&#xD;
      2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine. The patient and the physicians performing&#xD;
      the nerve block and the assessment after the block,will be blinded to the type of local&#xD;
      anesthetic injected.&#xD;
&#xD;
      The physician performing the block will use standard aseptic technique and local anesthetic&#xD;
      infiltration of the skin. Then, using ultrasound guidance and a 22g Touhy needle, a&#xD;
      supraclavicular brachial plexus block will be placed using 25 mls of the study drug. The time&#xD;
      of beginning of injection will be recorded. Starting at 10 minutes after injection, motor and&#xD;
      sensory exam in the distribution of the ulnar, median, radial and musculocutaneous nerves&#xD;
      using pinprick every 3 minutes until motor block and sensory block is complete. As has been&#xD;
      used in prior studies, motor scores of 0, 1, and 2 will be used for no motor blockade (0),&#xD;
      partial motor blockade (1), and complete motor blockade (2). Similarly, sensory scores will&#xD;
      reflect no change in pinprick sensitivity (0), diminished pinprick sensitivity (1), and&#xD;
      complete loss of sensitivity to pinprick (2). Being ready for surgical anesthesia will be&#xD;
      defined as a score of 2 for sensory testing. Any patient not achieving a score of 2 on the&#xD;
      sensory scale by 40 minutes will be considered a failed block. These scores will be recorded&#xD;
      every 3 minutes until the block achieves scores of 2 and 2 or until the patient goes to the&#xD;
      operating room (OR).&#xD;
&#xD;
      Once in the OR, data will be collected on whether or not the patient experienced pain on&#xD;
      incision, required supplemental pain medicine or sedation, or if the patient required general&#xD;
      anesthesia and the reason for needing general anesthesia (e.g. patient discomfort, surgeon&#xD;
      request, etc). Post-operatively, a motor and sensory exam will again be performed on the&#xD;
      patients for whom the nerve block did not achieve scores of 2 and 2 prior to undergoing&#xD;
      surgery and on the patients who required general anesthesia. The patient will be given a card&#xD;
      as a reminder to write down the time when he/she noticed pain at site of the operation for&#xD;
      the first time and separately the time when he/she took pain medication for the first time.&#xD;
      The night of the surgery the patient will be contacted over the phone by one of the&#xD;
      investigators to ask the time of pain onset and pain medication administration. Additional&#xD;
      data regarding the patient age, weight, type of surgery, and sex will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">November 2010</completion_date>
  <primary_completion_date type="Actual">November 2010</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>Onset of Surgical Anesthesia</measure>
    <time_frame>45 minutes</time_frame>
    <description>Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Analgesia</measure>
    <time_frame>72 hours</time_frame>
    <description>Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Ropivacine and Cholroprocaine mixture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacine only</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacine and Chloroprocaine mixture</intervention_name>
    <description>Chloroprocaine is added to Ropivacaine</description>
    <arm_group_label>Ropivacine and Cholroprocaine mixture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine only</intervention_name>
    <description>Ropivacaine diluted with normal saline instead of chloroprocaine</description>
    <arm_group_label>Ropivacine only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who will be having a supraclavicular brachial plexus block as part of their&#xD;
             anesthetic will be approached for possible inclusion in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are pregnant,&#xD;
&#xD;
          -  have an ASA status of IV or greater,&#xD;
&#xD;
          -  neuropathy,&#xD;
&#xD;
          -  a cast or other impediment to performing a motor or sensory exam in the arm and hand,&#xD;
&#xD;
          -  patients under the age of 18,&#xD;
&#xD;
          -  long term opioid therapy (longer than 1 month),&#xD;
&#xD;
          -  history of opioid abuse and pseudocholinesterase deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>August 19, 2022</results_first_submitted>
  <results_first_submitted_qc>August 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2022</results_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Onset</keyword>
  <keyword>Duration</keyword>
  <keyword>Upper Limb Block</keyword>
  <keyword>Ultrasound guided supraclavicular block</keyword>
  <keyword>Ropivacaine</keyword>
  <keyword>Chloroprocaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ropivacaine and Cholroprocaine Mixture</title>
          <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine&#xD;
Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine</description>
        </group>
        <group group_id="P2">
          <title>Ropivacaine Only</title>
          <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine&#xD;
Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ropivacaine and Cholroprocaine Mixture</title>
          <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine&#xD;
Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine</description>
        </group>
        <group group_id="B2">
          <title>Ropivacaine Only</title>
          <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine&#xD;
Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine</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="30"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" lower_limit="23" upper_limit="79"/>
                    <measurement group_id="B2" value="46" lower_limit="18" upper_limit="71"/>
                    <measurement group_id="B3" value="48" lower_limit="18" upper_limit="79"/>
                  </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="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight (Kg)</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.4" spread="20.5"/>
                    <measurement group_id="B2" value="80.7" spread="19"/>
                    <measurement group_id="B3" value="83.6" spread="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (Kg/m^2)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.2" spread="8.7"/>
                    <measurement group_id="B2" value="28.0" spread="5.7"/>
                    <measurement group_id="B3" value="29.1" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Onset of Surgical Anesthesia</title>
        <description>Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves</description>
        <time_frame>45 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ropivacaine and Cholroprocaine Mixture</title>
            <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine&#xD;
Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine Only</title>
            <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine&#xD;
Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Onset of Surgical Anesthesia</title>
          <description>Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves</description>
          <units>minutes</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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ulnar-Sensory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="10" upper_limit="28"/>
                    <measurement group_id="O2" value="22" lower_limit="13" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median-Sensory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="4" upper_limit="16"/>
                    <measurement group_id="O2" value="16" lower_limit="10" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Radial-Sensory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="4" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="7" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Musculocutaneous-Sensory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="4" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="7" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Analgesia</title>
        <description>Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery</description>
        <time_frame>72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ropivacaine and Cholroprocaine Mixture</title>
            <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine&#xD;
Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine Only</title>
            <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine&#xD;
Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Analgesia</title>
          <description>Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery</description>
          <units>minutes</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="30"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="566" lower_limit="428" upper_limit="670"/>
                    <measurement group_id="O2" value="718" lower_limit="597" upper_limit="851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ropivacaine and Cholroprocaine Mixture</title>
          <description>20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine&#xD;
Ropivacine and Chloroprocaine mixture: Chloroprocaine is added to Ropivacaine</description>
        </group>
        <group group_id="E2">
          <title>Ropivacaine Only</title>
          <description>30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine&#xD;
Ropivacaine only: Ropivacaine diluted with normal saline instead of chloroprocaine</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Block Failure</sub_title>
                <description>Failure of nerve block procedure to provide complete surgical anesthesia</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </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. Nicholas Lam</name_or_title>
      <organization>University of New Mexico</organization>
      <phone>505-272-2610</phone>
      <email>nlam@salud.unm.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/NCT01719237
org study id: ChloroRopiSCB
nct id: NCT01719237
lead sponsor: 
collaborator: 
has dmc: No
A double blinded randomized controlled trial comparing the onset and duration of the Onset
      and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local
      anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic
      (Ropivacaine-Chloroprocaine Mixture).
Patients will be met preoperatively in the pre-anesthesia holding area as is typical for most
      orthopedic procedures. An attending anesthesiologist will evaluate the patient and planned
      surgical procedure and determine if the best anesthetic plan includes a supraclavicular
      brachial plexus block and will ensure that the patient provides informed consent for their
      anesthetic plan. Patients who will be having a supraclavicular brachial plexus block as part
      of their anesthetic will be approached for possible inclusion in the study.

      The patient's surgical site will be verified by standard time out procedure. Standard
      monitoring will be placed including pulse oximetry, EKG, and non-invasive blood pressure
      cuff. A nasal canula will be placed to provide oxygen. The patient may be given midazolam IV
      up to 0.05 mg/kg as needed for anxiolysis. The supraclavicular brachial plexus block will be
      performed by either the attending anesthesiologist or a resident physician directly
      supervised by the attending anesthesiologist using ultrasound guidance.

      The randomization envelope will be handed to an anesthesiologist not involved in the
      patient's care who will fill a 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's
      of normal saline + 0.1 ml of 1mg/ml epinephrine or 20 ml's of 1% ropivacaine + 10 ml's of 3%
      2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine. The patient and the physicians performing
      the nerve block and the assessment after the block,will be blinded to the type of local
      anesthetic injected.

      The physician performing the block will use standard aseptic technique and local anesthetic
      infiltration of the skin. Then, using ultrasound guidance and a 22g Touhy needle, a
      supraclavicular brachial plexus block will be placed using 25 mls of the study drug. The time
      of beginning of injection will be recorded. Starting at 10 minutes after injection, motor and
      sensory exam in the distribution of the ulnar, median, radial and musculocutaneous nerves
      using pinprick every 3 minutes until motor block and sensory block is complete. As has been
      used in prior studies, motor scores of 0, 1, and 2 will be used for no motor blockade (0),
      partial motor blockade (1), and complete motor blockade (2). Similarly, sensory scores will
      reflect no change in pinprick sensitivity (0), diminished pinprick sensitivity (1), and
      complete loss of sensitivity to pinprick (2). Being ready for surgical anesthesia will be
      defined as a score of 2 for sensory testing. Any patient not achieving a score of 2 on the
      sensory scale by 40 minutes will be considered a failed block. These scores will be recorded
      every 3 minutes until the block achieves scores of 2 and 2 or until the patient goes to the
      operating room (OR).

      Once in the OR, data will be collected on whether or not the patient experienced pain on
      incision, required supplemental pain medicine or sedation, or if the patient required general
      anesthesia and the reason for needing general anesthesia (e.g. patient discomfort, surgeon
      request, etc). Post-operatively, a motor and sensory exam will again be performed on the
      patients for whom the nerve block did not achieve scores of 2 and 2 prior to undergoing
      surgery and on the patients who required general anesthesia. The patient will be given a card
      as a reminder to write down the time when he/she noticed pain at site of the operation for
      the first time and separately the time when he/she took pain medication for the first time.
      The night of the surgery the patient will be contacted over the phone by one of the
      investigators to ask the time of pain onset and pain medication administration. Additional
      data regarding the patient age, weight, type of surgery, and sex will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Onset of Surgical Anesthesia
time frame: 45 minutes
description: Onset of surgical anesthesia is defined as the time after injection of local anesthetic to the time where no sensation of pinprick in the ulnar, median, radial and musculocutaneous nerves
measure: Duration of Analgesia
time frame: 72 hours
description: Time interval between the end of local anestehtic injection and the patient's first report of pain in the surgical site after surgery
arm group label: Ropivacine and Cholroprocaine mixture
arm group type: Active Comparator
description: 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine
arm group label: Ropivacine only
arm group type: Sham Comparator
description: 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine
intervention type: Drug
intervention name: Ropivacine and Chloroprocaine mixture
description: Chloroprocaine is added to Ropivacaine
arm group label: Ropivacine and Cholroprocaine mixture
intervention type: Drug
intervention name: Ropivacaine only
description: Ropivacaine diluted with normal saline instead of chloroprocaine
arm group label: Ropivacine only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ropivacaine
mesh term: Chloroprocaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 