<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/NCT03805438</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100699</org_study_id>
    <nct_id>NCT03805438</nct_id>
  </id_info>
  <brief_title>ED90 of 3% Chloroprocaine for Cervical Cerclage</brief_title>
  <official_title>Determining the ED90 for Intrathecal 3% Chloroprocaine for Elective Cervical Cerclage Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that&#xD;
      provides effective anesthesia in 90% of patients undergoing elective cerclage placement&#xD;
      (intraoperative analgesic supplementation not required).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cerclage is a procedure performed on pregnant women with cervical incompetence to&#xD;
      reduce the risk of second trimester spontaneous abortion and preterm labor. This outpatient&#xD;
      procedure is performed commonly under both general and regional anesthesia. In an effort to&#xD;
      ensure rapid discharge some institutions prefer the use of general anesthesia; however, this&#xD;
      has the disadvantage of exposing the fetus to general anesthetic drugs, increased risk of&#xD;
      aspiration and a higher requirement for opioid analgesia post operatively. The benefits of&#xD;
      neuraxial anesthesia for cerclage placement includes rapid onset of a dense sensory block,&#xD;
      reduced fetus exposure to medications, and maintenance of maternal airway reflexes.&#xD;
      Successful analgesia for cerclage placement requires a sensory block from S4-T10 dermatomes.&#xD;
      Inadequate sensory coverage with a spinal anesthetic typically necessitates the conversion to&#xD;
      general anesthesia adding risk to the mother and fetus while increasing intraoperative times&#xD;
      and resources. Currently there are no studies determining optimum dose of spinal&#xD;
      chloroprocaine for cervical cerclage. The investigators propose a dose determining study to&#xD;
      determine the ED90 of intrathecal lidocaine and chloroprocaine which will help decrease&#xD;
      incidence of inadequate anesthesia for cervical cerclage.&#xD;
&#xD;
      This is a multicenter, double blinded, dose ranging, biased-coin design study. Usual practice&#xD;
      for regional anesthesia for cerclage placement consists of a mixture of 3% chloroprocaine and&#xD;
      fentanyl. The exact dosing of the local anesthetic mixture used is dependent on the&#xD;
      anesthesiologist's preference. Chloroprocaine provides a rapid onset of surgical anesthesia&#xD;
      with little need for intraoperative analgesic supplementation. If there are contraindications&#xD;
      for spinal anesthesia or patient refusal than general anesthesia is offered as an&#xD;
      alternative.&#xD;
&#xD;
      The aim of this study is to assess the anesthetic quality of various doses chloroprocaine and&#xD;
      in elective cerclage placement. Chloroprocaine is licensed and commonly administered&#xD;
      intrathecally for cerclage placement.&#xD;
&#xD;
      To mitigate against the occurrence of inadequate analgesia in this ED90 study, a combined&#xD;
      spinal-epidural technique will be utilized in order to provide supplemental analgesia via&#xD;
      epidural top up if needed.&#xD;
&#xD;
      The investigators propose testing the hypothesis in patients scheduled for elective cervical&#xD;
      cerclage placement. Participants will receive standard of care for anesthesia but in the&#xD;
      context of a clinical trial with the addition of randomization, blinding, and more&#xD;
      comprehensive evaluation of the trial outcomes (see outcomes objectives below).&#xD;
&#xD;
      The proposed study will be conducted over a 2 year period from January 2019 to September&#xD;
      2020.&#xD;
&#xD;
      Spinal Study Solutions The solutions and their administration procedures are identical to&#xD;
      those used outside this research and are almost exclusively used for patients requiring&#xD;
      spinal anesthesia for cervical cerclage. The only deviation involves diluting the&#xD;
      chloroprocaine with saline so that study solutions are of equal volume to maintain blinding.&#xD;
&#xD;
      Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be&#xD;
      drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in&#xD;
      aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of&#xD;
      fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the&#xD;
      syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and&#xD;
      administered by another anesthesiologist (blinded).&#xD;
&#xD;
      Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject&#xD;
      and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50&#xD;
      mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is&#xD;
      2 ml.&#xD;
&#xD;
      Rescue If the subject has discomfort and requests analgesia, then 5 ml of 3% chloroprocaine&#xD;
      via the epidural route will be given, alternatively the anesthesiologist can treat the&#xD;
      discomfort at his discretion. Other alternatives include intravenous fentanyl, ketamine,&#xD;
      inhalational nitrous oxide and conversion to general anesthesia.&#xD;
&#xD;
      Riks/Benefit Risks of the procedure include the following: discomfort during placement (10%&#xD;
      or 1 in 10), drop in blood pressure (1% or 1 in 100), headache (1% or 1 in 100), allergic&#xD;
      reactions (0.001% or 1 in 100,000), bleeding or infection (0.001% or 1 in 100,000), damage to&#xD;
      nerves (0.001% or 1 in 100,000), failure of the anesthetic or inadequate anesthesia and need&#xD;
      for general anesthesia (0.1% or 1 in 1,000). The benefit of participating in the study is&#xD;
      that perceived pain may be better controlled, however this cannot be guaranteed.&#xD;
&#xD;
      This study will be conducted at two study sites, the University of Arkansas for Medical&#xD;
      Sciences in Little Rock, Arkansas and Duke University in Durham, North Carolina.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">October 23, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The solutions and their administration procedures are identical to those used outside this research and are almost exclusively used for patients requiring spinal anesthesia for cervical cerclage. The only deviation involves diluting the chloroprocaine with saline so that study solutions are of equal volume to maintain blinding.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).</measure>
    <time_frame>60 minutes</time_frame>
    <description>The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Number of participants reporting nausea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Observed Vomiting. (Observed Yes or no).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Number of participants with observed vomiting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Number of participants reporting itching.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</measure>
    <time_frame>60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</measure>
    <time_frame>60 minutes</time_frame>
    <description>All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Patient Satisfaction at Time of PACU Discharge.</measure>
    <time_frame>60 minutes</time_frame>
    <description>The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).</measure>
    <time_frame>60 minutes</time_frame>
    <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes</measure>
    <time_frame>approximately 180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Spinal Block to Ambulation</measure>
    <time_frame>up to 180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Spinal Block to Micturition</measure>
    <time_frame>approximately 180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Complete Sensory Regression</measure>
    <time_frame>up to 180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Resolution of Motor Block (Bromage Score of 5)</measure>
    <time_frame>up to 180 minutes</time_frame>
    <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)</measure>
    <time_frame>approximately 180 minutes</time_frame>
    <description>Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Cerclage, Cervical</condition>
  <arm_group>
    <arm_group_label>Chloroprocaine dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chloroprocaine Hcl 3% Inj</intervention_name>
    <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
    <arm_group_label>Chloroprocaine dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  ASA class II or III&#xD;
&#xD;
          -  Cervical cerclage 1st or 2nd trimester of pregnancy&#xD;
&#xD;
          -  Simple prophylactic cervical cerclage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Abdominal and complex cervical cerclage (e.g. bulging bag)&#xD;
&#xD;
          -  BMI ≥ 50 kg/m2&#xD;
&#xD;
          -  ASA class IV or above&#xD;
&#xD;
          -  Contraindication to neuraxial anesthesia&#xD;
&#xD;
          -  Allergy to chloroprocaine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashraf Habib, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <results_first_submitted>August 5, 2021</results_first_submitted>
  <results_first_submitted_qc>August 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2021</results_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroprocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared between institutions insofar as it is required for the sequential study design when evaluating the primary outcome. The dose of chloroprocaine used for each procedure as well as the outcome of the surgery will dictate the dosing for the next patient at either institution. PHI will not be shared however.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>The study protocol will be shared between institutions and will be identical. The SAP, CSR, and analytic code is also shared and identical. The ICF however will be different and each institution will use its own version of the consent form.</ipd_time_frame>
    <ipd_access_criteria>Shared data will be stored in REDCap to be used between institutions. The data will be shared by the PIs and all members listed on the Duke IRB submission both at Duke and UAMS. All statistical analyses will be done at Duke.</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>February 25, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03805438/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Chloroprocaine Dose</title>
          <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who completed the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Chloroprocaine Dose</title>
          <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </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="32" lower_limit="29" upper_limit="37"/>
                  </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="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).</title>
        <description>Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).</title>
          <description>Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.</description>
          <population>Participants who completed the study.</population>
          <units>mg</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" lower_limit="45.0" upper_limit="50.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).</title>
        <description>The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).</title>
          <description>The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.</description>
          <population>Participants who completed the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).</title>
        <description>Number of participants reporting nausea.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).</title>
          <description>Number of participants reporting nausea.</description>
          <population>Participants who completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Observed Vomiting. (Observed Yes or no).</title>
        <description>Number of participants with observed vomiting.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Observed Vomiting. (Observed Yes or no).</title>
          <description>Number of participants with observed vomiting.</description>
          <population>Participants who completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).</title>
        <description>Number of participants reporting itching.</description>
        <time_frame>60 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).</title>
          <description>Number of participants reporting itching.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</title>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</title>
          <population>Participants who completed the study.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</title>
        <description>All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or &lt; 100mg Hg Systolic.</title>
          <description>All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.</description>
          <population>Participants who completed the study.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="320" lower_limit="100" upper_limit="460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Patient Satisfaction at Time of PACU Discharge.</title>
        <description>The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Patient Satisfaction at Time of PACU Discharge.</title>
          <description>The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used.</description>
          <population>Participants who completed the study.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="10" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).</title>
        <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
        <time_frame>60 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).</title>
          <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="45" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes</title>
        <time_frame>approximately 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes</title>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" lower_limit="139" upper_limit="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Spinal Block to Ambulation</title>
        <time_frame>up to 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Spinal Block to Ambulation</title>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="45" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Spinal Block to Micturition</title>
        <time_frame>approximately 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Spinal Block to Micturition</title>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" lower_limit="139" upper_limit="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete Sensory Regression</title>
        <time_frame>up to 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete Sensory Regression</title>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="75" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Resolution of Motor Block (Bromage Score of 5)</title>
        <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
        <time_frame>up to 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Resolution of Motor Block (Bromage Score of 5)</title>
          <description>The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.</description>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="45" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)</title>
        <description>Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate.</description>
        <time_frame>approximately 180 minutes</time_frame>
        <population>Participants who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Chloroprocaine Dose</title>
            <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)</title>
          <description>Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate.</description>
          <population>Participants who completed the study.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150" lower_limit="139" upper_limit="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 180 minutes</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Chloroprocaine Dose</title>
          <description>Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).&#xD;
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.&#xD;
At the completion of this study, there were no adverse events experienced by any patients enrolled in the study. As such, the delineation of adverse events on a per dose level is unnecessary.</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="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
              </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="47"/>
              </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>Riley Landreth, DO</name_or_title>
      <organization>Duke University</organization>
      <phone>919-684-8111</phone>
      <email>riley.landreth@duke.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/NCT03805438
org study id: Pro00100699
nct id: NCT03805438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that
      provides effective anesthesia in 90% of patients undergoing elective cerclage placement
      (intraoperative analgesic supplementation not required).
Cervical cerclage is a procedure performed on pregnant women with cervical incompetence to
      reduce the risk of second trimester spontaneous abortion and preterm labor. This outpatient
      procedure is performed commonly under both general and regional anesthesia. In an effort to
      ensure rapid discharge some institutions prefer the use of general anesthesia; however, this
      has the disadvantage of exposing the fetus to general anesthetic drugs, increased risk of
      aspiration and a higher requirement for opioid analgesia post operatively. The benefits of
      neuraxial anesthesia for cerclage placement includes rapid onset of a dense sensory block,
      reduced fetus exposure to medications, and maintenance of maternal airway reflexes.
      Successful analgesia for cerclage placement requires a sensory block from S4-T10 dermatomes.
      Inadequate sensory coverage with a spinal anesthetic typically necessitates the conversion to
      general anesthesia adding risk to the mother and fetus while increasing intraoperative times
      and resources. Currently there are no studies determining optimum dose of spinal
      chloroprocaine for cervical cerclage. The investigators propose a dose determining study to
      determine the ED90 of intrathecal lidocaine and chloroprocaine which will help decrease
      incidence of inadequate anesthesia for cervical cerclage.

      This is a multicenter, double blinded, dose ranging, biased-coin design study. Usual practice
      for regional anesthesia for cerclage placement consists of a mixture of 3% chloroprocaine and
      fentanyl. The exact dosing of the local anesthetic mixture used is dependent on the
      anesthesiologist's preference. Chloroprocaine provides a rapid onset of surgical anesthesia
      with little need for intraoperative analgesic supplementation. If there are contraindications
      for spinal anesthesia or patient refusal than general anesthesia is offered as an
      alternative.

      The aim of this study is to assess the anesthetic quality of various doses chloroprocaine and
      in elective cerclage placement. Chloroprocaine is licensed and commonly administered
      intrathecally for cerclage placement.

      To mitigate against the occurrence of inadequate analgesia in this ED90 study, a combined
      spinal-epidural technique will be utilized in order to provide supplemental analgesia via
      epidural top up if needed.

      The investigators propose testing the hypothesis in patients scheduled for elective cervical
      cerclage placement. Participants will receive standard of care for anesthesia but in the
      context of a clinical trial with the addition of randomization, blinding, and more
      comprehensive evaluation of the trial outcomes (see outcomes objectives below).

      The proposed study will be conducted over a 2 year period from January 2019 to September
      2020.

      Spinal Study Solutions The solutions and their administration procedures are identical to
      those used outside this research and are almost exclusively used for patients requiring
      spinal anesthesia for cervical cerclage. The only deviation involves diluting the
      chloroprocaine with saline so that study solutions are of equal volume to maintain blinding.

      Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be
      drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in
      aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of
      fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the
      syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and
      administered by another anesthesiologist (blinded).

      Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject
      and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50
      mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is
      2 ml.

      Rescue If the subject has discomfort and requests analgesia, then 5 ml of 3% chloroprocaine
      via the epidural route will be given, alternatively the anesthesiologist can treat the
      discomfort at his discretion. Other alternatives include intravenous fentanyl, ketamine,
      inhalational nitrous oxide and conversion to general anesthesia.

      Riks/Benefit Risks of the procedure include the following: discomfort during placement (10%
      or 1 in 10), drop in blood pressure (1% or 1 in 100), headache (1% or 1 in 100), allergic
      reactions (0.001% or 1 in 100,000), bleeding or infection (0.001% or 1 in 100,000), damage to
      nerves (0.001% or 1 in 100,000), failure of the anesthetic or inadequate anesthesia and need
      for general anesthesia (0.1% or 1 in 1,000). The benefit of participating in the study is
      that perceived pain may be better controlled, however this cannot be guaranteed.

      This study will be conducted at two study sites, the University of Arkansas for Medical
      Sciences in Little Rock, Arkansas and Duke University in Durham, North Carolina.
allocation: N/A
intervention model: Sequential Assignment
intervention model description: Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: The solutions and their administration procedures are identical to those used outside this research and are almost exclusively used for patients requiring spinal anesthesia for cervical cerclage. The only deviation involves diluting the chloroprocaine with saline so that study solutions are of equal volume to maintain blinding.
measure: The Dose of Intrathecal (IT) Chloroprocaine That Provides Effective Anesthesia in 90% of Patients Undergoing Elective Cerclage Placement (Intraoperative Analgesic Supplementation Not Required).
time frame: 60 minutes
description: Identification of the dose of intrathecal 3% chloroprocaine that will provide adequate anesthesia for a cervical cerclage to occur.
measure: Maximum Pain Numerical Pain Rating Scale (NPRS) During Surgery (as Reported by Patient, Scored From 0-10 in the PACU).
time frame: 60 minutes
description: The scale from 0-10 is used where a score of 0 represents no pain at all and a score of 10 represents the worst pain a participant could imagine. It is reported as a single score at a single point in time. No subscales are used.
measure: Number of Participants Who Reported Nausea (Self-reported by Patient, Yes or no).
time frame: 60 minutes
description: Number of participants reporting nausea.
measure: Number of Participants With Observed Vomiting. (Observed Yes or no).
time frame: 60 minutes
description: Number of participants with observed vomiting.
measure: Number of Participants Reporting Itching. (Self-reported by Patient, Yes or no).
time frame: 60 minutes
description: Number of participants reporting itching.
measure: Number of Patients Who Were Given Vasopressor Phenylephrine (and Ephedrine) BP Drops Greater Than 15% Below Baseline or < 100mg Hg Systolic.
time frame: 60 minutes
measure: The Average Dose of Phenylephrine Given to Those Patients Whose BP Dropped Greater Than 15% Below Baseline or < 100mg Hg Systolic.
time frame: 60 minutes
description: All patients were analyzed for possible requirement of this intervention, though all participants did not require the intervention.
measure: Overall Patient Satisfaction at Time of PACU Discharge.
time frame: 60 minutes
description: The scale used is 0-10 where 0 would represent completely unsatisfied and 10 would be completely satisfied. A 10 would imply that if a participant had to have the procedure performed again, it would be repeated in the exact same fashion it was carried out the first time. This will be assessed at the time of PACU discharge and will be asked one time. No subscales are used.
measure: Time to Resolution of Motor Block at End of the Cerclage Placement (Measured in the PACU).
time frame: 60 minutes
description: The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.
measure: Time to Hospital Discharge as Measured as the Time Difference Between Local Anesthetic Injection and Discharge Time as Recorded in the Medical Notes
time frame: approximately 180 minutes
measure: Time From Spinal Block to Ambulation
time frame: up to 180 minutes
measure: Time From Spinal Block to Micturition
time frame: approximately 180 minutes
measure: Time to Complete Sensory Regression
time frame: up to 180 minutes
measure: Time to Resolution of Motor Block (Bromage Score of 5)
time frame: up to 180 minutes
description: The motor block is assessed using the Bromage scale (1-5). The block is objectively assessed using this scale based on which joints a patient is able to mobilize following epidural or subarachnoid block. A score of 1 represents a patient who is unable to mobilize any lower extremity joint. A score of 5 represents a patient able to mobilize all lower extremity joints.
measure: Time to Readiness for PACU Discharge (Pre-defined Nursing Criteria)
time frame: approximately 180 minutes
description: Readiness for PACU discharge would include a patient who is able to ambulate unassisted (indicating resolution of motor block), has vital signs within normal limits, has pain levels acceptable to the patient, and has been able to urinate.
arm group label: Chloroprocaine dose
arm group type: Experimental
description: Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.
intervention type: Drug
intervention name: Chloroprocaine Hcl 3% Inj
description: Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).
Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml.
arm group label: Chloroprocaine dose
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ashraf Habib, MBBS
role: Principal Investigator
affiliation: Duke University Hospital
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chloroprocaine
sharing ipd: Yes
ipd description: IPD will be shared between institutions insofar as it is required for the sequential study design when evaluating the primary outcome. The dose of chloroprocaine used for each procedure as well as the outcome of the surgery will dictate the dosing for the next patient at either institution. PHI will not be shared however.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: The study protocol will be shared between institutions and will be identical. The SAP, CSR, and analytic code is also shared and identical. The ICF however will be different and each institution will use its own version of the consent form.
ipd access criteria: Shared data will be stored in REDCap to be used between institutions. The data will be shared by the PIs and all members listed on the Duke IRB submission both at Duke and UAMS. All statistical analyses will be done at Duke.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 