<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/NCT03305575</url>
  </required_header>
  <id_info>
    <org_study_id>12619</org_study_id>
    <nct_id>NCT03305575</nct_id>
  </id_info>
  <brief_title>Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage</brief_title>
  <official_title>A Randomized Controlled Clinical Trial of Intrathecal Chloroprocaine vs. Bupivacaine for Cervical Cerclage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts Medical Center</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor&#xD;
      block and duration until meeting discharge criteria in patients undergoing cervical cerclage.&#xD;
      The hypothesis is that chloroprocaine will result in faster resolution of motor block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed&#xD;
      under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their&#xD;
      use impacts clinical care, in particular patient flow, is not well studied.&#xD;
&#xD;
      This is a prospective, randomized, double blind, controlled trial. Participants meeting&#xD;
      inclusion criteria will be randomly allocated to receive spinal anesthesia with either&#xD;
      chloroprocaine or bupivacaine.&#xD;
&#xD;
      Patients will then be assessed for motor block and sensory level until they are discharged&#xD;
      from the recovery room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Actual">August 24, 2018</completion_date>
  <primary_completion_date type="Actual">August 24, 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>
    <intervention_model_description>Prospective, randomized, double blinded clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient.&#xD;
Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Motor Block</measure>
    <time_frame>6 hours</time_frame>
    <description>The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale:&#xD;
I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Sensory Block</measure>
    <time_frame>6 hours</time_frame>
    <description>The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Ambulation</measure>
    <time_frame>6 hours</time_frame>
    <description>The time difference between local anesthetic injection and patient's walking for the first time postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Micturation</measure>
    <time_frame>6 hours</time_frame>
    <description>The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Cervical Incompetence</condition>
  <arm_group>
    <arm_group_label>Chloroprocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroprocaine</intervention_name>
    <description>The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.&#xD;
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.</description>
    <arm_group_label>Chloroprocaine</arm_group_label>
    <other_name>Sensorcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.&#xD;
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.</description>
    <arm_group_label>Bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA classification II or III females&#xD;
&#xD;
          -  Age: 18-45 years old&#xD;
&#xD;
          -  BMI ≤ 50 kg/m2&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Simple prophylactic cervical cerclage&#xD;
&#xD;
          -  Planning neuraxial anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominal and complex cervical cerclage (e.g. bulging bag)&#xD;
&#xD;
          -  Contraindication to neuraxial anesthesia&#xD;
&#xD;
          -  Known hypersensitivity to chloroprocaine (a.k.a. Ester allergy), paraaminobenzoic acid&#xD;
             (PABA) or bupivacaine (a.k.a. Amide allergy)&#xD;
&#xD;
          -  Pseudocholinesterase deficiency&#xD;
&#xD;
          -  Concomitant use with ergot-type oxytocic drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Drzymalski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.</citation>
    <PMID>6705717</PMID>
  </reference>
  <reference>
    <citation>Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.</citation>
    <PMID>21203878</PMID>
  </reference>
  <reference>
    <citation>Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.</citation>
    <PMID>15673895</PMID>
  </reference>
  <reference>
    <citation>Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.</citation>
    <PMID>17377114</PMID>
  </reference>
  <reference>
    <citation>Beilin Y, Zahn J, Abramovitz S, Bernstein HH, Hossain S, Bodian C. Subarachnoid small-dose bupivacaine versus lidocaine for cervical cerclage. Anesth Analg. 2003 Jul;97(1):56-61, table of contents. doi: 10.1213/01.ane.0000068940.36040.54.</citation>
    <PMID>12818944</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <results_first_submitted>September 10, 2019</results_first_submitted>
  <results_first_submitted_qc>August 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 25, 2020</results_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cervical Cerclage</keyword>
  <keyword>Bupivacaine</keyword>
  <keyword>Chloroprocaine</keyword>
  <keyword>spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Incompetence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>September 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03305575/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chloroprocaine</title>
          <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
        </group>
        <group group_id="P2">
          <title>Bupivacaine</title>
          <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chloroprocaine</title>
          <description>Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)&#xD;
Chloroprocaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.&#xD;
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.</description>
        </group>
        <group group_id="B2">
          <title>Bupivacaine</title>
          <description>Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).&#xD;
Bupivacaine: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.&#xD;
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.</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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </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="5"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" spread="4.5"/>
                    <measurement group_id="B2" value="29" spread="3.8"/>
                    <measurement group_id="B3" value="31" spread="4.5"/>
                  </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="5"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <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>BMI</title>
          <units>Kg/m^2</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="5"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.4" spread="5.9"/>
                    <measurement group_id="B2" value="29.7" spread="5.9"/>
                    <measurement group_id="B3" value="30" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA</title>
          <description>ASA classification ranges from I to V per the American Society of Anesthesiologists (ASA) as follow:&#xD;
ASA I: A normal healthy patient ASA II: A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation</description>
          <units>Scores on a scale</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="5"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" spread="0.58"/>
                    <measurement group_id="B2" value="2" spread="0"/>
                    <measurement group_id="B3" value="2.1" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational age</title>
          <units>weeks</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="5"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16" spread="3.9"/>
                    <measurement group_id="B2" value="14.8" spread="3.7"/>
                    <measurement group_id="B3" value="15.4" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Motor Block</title>
        <description>The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale:&#xD;
I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine</title>
            <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Motor Block</title>
          <description>The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale:&#xD;
I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="5.7"/>
                    <measurement group_id="O2" value="99" spread="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Sensory Block</title>
        <description>The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine</title>
            <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Sensory Block</title>
          <description>The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127" spread="20.6"/>
                    <measurement group_id="O2" value="210" spread="56.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Ambulation</title>
        <description>The time difference between local anesthetic injection and patient's walking for the first time postoperatively.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine</title>
            <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Ambulation</title>
          <description>The time difference between local anesthetic injection and patient's walking for the first time postoperatively.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110" spread="1.4"/>
                    <measurement group_id="O2" value="179" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Micturation</title>
        <description>The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.</description>
        <time_frame>6 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine</title>
            <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine</title>
            <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Micturation</title>
          <description>The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111" spread="1.3"/>
                    <measurement group_id="O2" value="233" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>until the subjects were discharged form the post anesthesia care unit up to 6 hours.</time_frame>
      <desc>There were no adverse evens noted.</desc>
      <group_list>
        <group group_id="E1">
          <title>Chloroprocaine</title>
          <description>Patients assigned to chlorprocaine received a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)</description>
        </group>
        <group group_id="E2">
          <title>Bupivacaine</title>
          <description>Patients assigned to bupivacaine received a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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>Alaa Basura, MD</name_or_title>
      <organization>Tufts Medical Center</organization>
      <phone>6176365000 ext 6208</phone>
      <email>abasura@tuftsmedicalcenter.org</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/NCT03305575
org study id: 12619
nct id: NCT03305575
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study aims to compare the effect of chloroprocaine vs. bupivacaine on duration of motor
      block and duration until meeting discharge criteria in patients undergoing cervical cerclage.
      The hypothesis is that chloroprocaine will result in faster resolution of motor block.
Cervical cerclage is an ambulatory surgical procedure of short duration commonly performed
      under spinal anesthesia. Bupivaciane and chlororpocaine are both commonly used, but how their
      use impacts clinical care, in particular patient flow, is not well studied.

      This is a prospective, randomized, double blind, controlled trial. Participants meeting
      inclusion criteria will be randomly allocated to receive spinal anesthesia with either
      chloroprocaine or bupivacaine.

      Patients will then be assessed for motor block and sensory level until they are discharged
      from the recovery room.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, double blinded clinical trial.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The anesthesia provider responsible for the clinical care of the patient will be given an envelope prepared during randomization and instructed to open it and prepare the medication in a separate room, such that the investigator and patient cannot see which vial is being used to prepare the medication. The anesthesia provider will also be instructed not to reveal the allocation group to the investigator or the patient.
Both bupivacaine and chloroprocaine are clear liquids, and the intended doses of both medications are the same volume, to insure complete blinding.
measure: Duration of Motor Block
time frame: 6 hours
description: The time difference between local anesthetic injection and complete resolution of motor block -as measured on the Bromage scale:
I = free movement of feet, legs and hip = No block II = able to flex knees, with free movement of feet = Mild block III = unable to flex knees, but with free movement of feet = Moderate block IV = unable to move legs or feet = Complete block
measure: Duration of Sensory Block
time frame: 6 hours
description: The time difference between local anesthetic injection and complete resolution of sensory block. The sensory level was tested using a blunt needle tip along the patient's demratomal distribution of the spinal anesthetic.
measure: Time to Ambulation
time frame: 6 hours
description: The time difference between local anesthetic injection and patient's walking for the first time postoperatively.
measure: Time to Micturation
time frame: 6 hours
description: The time difference between local anesthetic injection and the patient's voiding for the first time postoperatively.
arm group label: Chloroprocaine
arm group type: Experimental
description: Patients assigned to chlorprocaine will receive a single spinal injection of 40 mg of chloroprocaine PF. (other name: pure Nesacaine MPF 3% in a total volume of 2ml)
arm group label: Bupivacaine
arm group type: Active Comparator
description: Patients assigned to bupivacaine will receive a single spinal injection of 7.5 mg of bupivacaine. (other name: pure Sensorcaine 0.75% diluted with normal saline to a total volume of 2ml).
intervention type: Drug
intervention name: Chloroprocaine
description: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
arm group label: Chloroprocaine
other name: Sensorcaine
intervention type: Drug
intervention name: Bupivacaine
description: The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia.
arm group label: Bupivacaine
other name: Marcaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Dan Drzymalski, MD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
citation: Concepcion M, Covino BG. Rational use of local anaesthetics. Drugs. 1984 Mar;27(3):256-70. doi: 10.2165/00003495-198427030-00005.
PMID: 6705717
citation: Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4.
PMID: 21203878
citation: Yoos JR, Kopacz DJ. Spinal 2-chloroprocaine: a comparison with small-dose bupivacaine in volunteers. Anesth Analg. 2005 Feb;100(2):566-572. doi: 10.1213/01.ANE.0000143356.17013.A1.
PMID: 15673895
citation: Casati A, Fanelli G, Danelli G, Berti M, Ghisi D, Brivio M, Putzu M, Barbagallo A. Spinal anesthesia with lidocaine or preservative-free 2-chlorprocaine for outpatient knee arthroscopy: a prospective, randomized, double-blind comparison. Anesth Analg. 2007 Apr;104(4):959-64. doi: 10.1213/01.ane.0000258766.73612.d8.
PMID: 17377114
citation: Beilin Y, Zahn J, Abramovitz S, Bernstein HH, Hossain S, Bodian C. Subarachnoid small-dose bupivacaine versus lidocaine for cervical cerclage. Anesth Analg. 2003 Jul;97(1):56-61, table of contents. doi: 10.1213/01.ane.0000068940.36040.54.
PMID: 12818944
responsible party type: Sponsor
mesh term: Uterine Cervical Incompetence
mesh term: Bupivacaine
mesh term: Chloroprocaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 