<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/NCT03760718</url>
  </required_header>
  <id_info>
    <org_study_id>19021</org_study_id>
    <nct_id>NCT03760718</nct_id>
  </id_info>
  <brief_title>Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery</brief_title>
  <acronym>CLOR-PRO</acronym>
  <official_title>Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science 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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long term objective is to show that intraperitoneal chloroprocaine can be used an&#xD;
      alternative option to avoid general anesthesia during cesarean delivery, to alleviate&#xD;
      mother's discomfort from surgical pain, reduce complications, and improve the birth&#xD;
      experience. The objectives in this study are to determine the amount of chloroprocaine that&#xD;
      is absorbed into the blood in order to create a plasma concentration time profile and to&#xD;
      determine the incidence of side effects to help guide selection of an appropriate&#xD;
      concentration for future study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated&#xD;
      with a lower risk for maternal aspiration and airway compromise, exposes the baby to less&#xD;
      anesthetic, and allows for greater maternal involvement in the birth process. For these&#xD;
      reasons, it has become the preferred method of anesthesia for cesarean delivery. Spinals that&#xD;
      are placed to facilitate cesarean delivery have a duration of one to two hours. Currently, if&#xD;
      that duration is exceeded patients must have general endotracheal anesthesia. In addition,&#xD;
      suboptimal neuraxial anesthesia for cesarean delivery is not uncommon with an incidence of&#xD;
      2-9%, depending upon the urgency of surgery and the type of neuraxial block. Providing less&#xD;
      than adequate anesthesia for cesarean delivery may increase the risk of legal liability. For&#xD;
      this reason, some patients with suboptimal neuraxial anesthesia have intraoperative&#xD;
      conversion to general endotracheal anesthesia.&#xD;
&#xD;
      The first known description of the use of intraperitoneal local anesthetic to provide&#xD;
      anesthesia for cesarean delivery was published in 1975. In this article Ranney et al.&#xD;
      described how to use up to 100 mL of 1% procaine to provide anesthesia for cesarean delivery&#xD;
      under local field block alone. Some of this was injected into the skin and fascia, and the&#xD;
      remainder was diluted to 0.5% and &quot;spilled&quot; into the peritoneum.&#xD;
&#xD;
      Multiple publications have shown that intraperitoneal local anesthetic can be used to treat&#xD;
      intraoperative and postoperative pain, prevent postoperative nausea, and shorten hospital&#xD;
      length of stay. A recently published 40-month case series showed that chloroprocaine lavage&#xD;
      can be used as part of a multimodal approach to treating intraoperative pain. In this case&#xD;
      series, the technique of chloroprocaine lavage helped investigators to avoid general&#xD;
      endotracheal anesthesia in 32 women having a cesarean delivery.&#xD;
&#xD;
      In this case series, no patients exhibited clinical signs of systemic local anesthetic&#xD;
      toxicity. It is believed that chloroprocaine has a limited potential for toxicity because of&#xD;
      its short plasma half-life, which is only 11-21 seconds. The purpose of this study is to&#xD;
      determine the amount of chloroprocaine that is taken up into the blood stream after&#xD;
      intraperitoneal administration to ensure that blood levels are low and do not raise a safety&#xD;
      concern. Data obtained from this study will help to define a safe dose of chloroprocaine for&#xD;
      intraperitoneal administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 30, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 17, 2020</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chloroprocaine plasma concentration at 1 minute</measure>
    <time_frame>1 minute after intraperitoneal chloroprocaine administration</time_frame>
    <description>The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chloroprocaine plasma concentration at 5 minutes</measure>
    <time_frame>5 minutes after intraperitoneal chloroprocaine administration</time_frame>
    <description>The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chloroprocaine plasma concentration at 10 minutes</measure>
    <time_frame>10 minutes after intraperitoneal chloroprocaine administration</time_frame>
    <description>The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chloroprocaine plasma concentration at 20 minutes</measure>
    <time_frame>20 minutes after intraperitoneal chloroprocaine administration</time_frame>
    <description>The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chloroprocaine plasma concentration at 30 minutes</measure>
    <time_frame>30 minutes after intraperitoneal chloroprocaine administration</time_frame>
    <description>The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Within 4 hours of intraperitoneal chloroprocaine administration</time_frame>
    <description>Adverse experience reporting will include the following: seizures, tinnitus, metallic taste, anxiety, agitation, muscle twitching, drowsiness, respiratory depression, dizziness, nausea, vomiting, vision changes, paresthesias, perioral numbness, hypotension, arrhythmias, and cardiac arrest.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Preservative free Chloroprocaine Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 ml of preservative-free 1% chloroprocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preservative free Chloroprocaine Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 ml of preservative-free 2% chloroprocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preservative free Chloroprocaine Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 ml of preservative-free 3% chloroprocaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preservative free 1% Chloroprocaine</intervention_name>
    <description>40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.</description>
    <arm_group_label>Preservative free Chloroprocaine Group 1</arm_group_label>
    <other_name>Nesacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preservative free 2% Chloroprocaine</intervention_name>
    <description>40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.</description>
    <arm_group_label>Preservative free Chloroprocaine Group 2</arm_group_label>
    <other_name>Nesacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Preservative free 3% Chloroprocaine</intervention_name>
    <description>40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.</description>
    <arm_group_label>Preservative free Chloroprocaine Group 3</arm_group_label>
    <other_name>Nesacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and&#xD;
             Delivery) within Oregon Health &amp; Science University (OHSU).&#xD;
&#xD;
          -  Only subjects having spinal anesthesia will be eligible.&#xD;
&#xD;
          -  Only subjects that can have a Pfannenstiel incision will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with chronic narcotic usage&#xD;
&#xD;
          -  Subjects that are deemed to need a combined spinal epidural for any reason.&#xD;
&#xD;
          -  Subjects who are unable to successfully get a spinal block&#xD;
&#xD;
          -  Subjects with known atypical cholinesterase activity&#xD;
&#xD;
          -  American Society of Anesthesiologist physical status IV or higher&#xD;
&#xD;
          -  Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection)&#xD;
&#xD;
          -  Subjects with stage 4 chronic kidney disease or worse (eGFR &lt; 30 ml/min)&#xD;
&#xD;
          -  Subjects with significant hepatic dysfunction (AST or ALT &gt; 2x the upper limit of&#xD;
             normal)&#xD;
&#xD;
          -  Subjects with allergies to drugs required for this protocol.&#xD;
&#xD;
          -  Subjects with multifetal gestations&#xD;
&#xD;
          -  Subjects with a BMI &gt; 40 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brandon M Togioka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OHSU Labor and Delivery; Oregon Health and Science University Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.</citation>
    <PMID>1118089</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Brandon M Togioka</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>chloroprocaine</keyword>
  <keyword>cesarean delivery</keyword>
  <keyword>lavage</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chloroprocaine</mesh_term>
    <mesh_term>Procaine</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>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT03760718/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03760718
org study id: 19021
nct id: NCT03760718
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The long term objective is to show that intraperitoneal chloroprocaine can be used an
      alternative option to avoid general anesthesia during cesarean delivery, to alleviate
      mother's discomfort from surgical pain, reduce complications, and improve the birth
      experience. The objectives in this study are to determine the amount of chloroprocaine that
      is absorbed into the blood in order to create a plasma concentration time profile and to
      determine the incidence of side effects to help guide selection of an appropriate
      concentration for future study.
Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated
      with a lower risk for maternal aspiration and airway compromise, exposes the baby to less
      anesthetic, and allows for greater maternal involvement in the birth process. For these
      reasons, it has become the preferred method of anesthesia for cesarean delivery. Spinals that
      are placed to facilitate cesarean delivery have a duration of one to two hours. Currently, if
      that duration is exceeded patients must have general endotracheal anesthesia. In addition,
      suboptimal neuraxial anesthesia for cesarean delivery is not uncommon with an incidence of
      2-9%, depending upon the urgency of surgery and the type of neuraxial block. Providing less
      than adequate anesthesia for cesarean delivery may increase the risk of legal liability. For
      this reason, some patients with suboptimal neuraxial anesthesia have intraoperative
      conversion to general endotracheal anesthesia.

      The first known description of the use of intraperitoneal local anesthetic to provide
      anesthesia for cesarean delivery was published in 1975. In this article Ranney et al.
      described how to use up to 100 mL of 1% procaine to provide anesthesia for cesarean delivery
      under local field block alone. Some of this was injected into the skin and fascia, and the
      remainder was diluted to 0.5% and "spilled" into the peritoneum.

      Multiple publications have shown that intraperitoneal local anesthetic can be used to treat
      intraoperative and postoperative pain, prevent postoperative nausea, and shorten hospital
      length of stay. A recently published 40-month case series showed that chloroprocaine lavage
      can be used as part of a multimodal approach to treating intraoperative pain. In this case
      series, the technique of chloroprocaine lavage helped investigators to avoid general
      endotracheal anesthesia in 32 women having a cesarean delivery.

      In this case series, no patients exhibited clinical signs of systemic local anesthetic
      toxicity. It is believed that chloroprocaine has a limited potential for toxicity because of
      its short plasma half-life, which is only 11-21 seconds. The purpose of this study is to
      determine the amount of chloroprocaine that is taken up into the blood stream after
      intraperitoneal administration to ensure that blood levels are low and do not raise a safety
      concern. Data obtained from this study will help to define a safe dose of chloroprocaine for
      intraperitoneal administration.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Chloroprocaine plasma concentration at 1 minute
time frame: 1 minute after intraperitoneal chloroprocaine administration
description: The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.
measure: Chloroprocaine plasma concentration at 5 minutes
time frame: 5 minutes after intraperitoneal chloroprocaine administration
description: The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.
measure: Chloroprocaine plasma concentration at 10 minutes
time frame: 10 minutes after intraperitoneal chloroprocaine administration
description: The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.
measure: Chloroprocaine plasma concentration at 20 minutes
time frame: 20 minutes after intraperitoneal chloroprocaine administration
description: The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.
measure: Chloroprocaine plasma concentration at 30 minutes
time frame: 30 minutes after intraperitoneal chloroprocaine administration
description: The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.
measure: Adverse Events
time frame: Within 4 hours of intraperitoneal chloroprocaine administration
description: Adverse experience reporting will include the following: seizures, tinnitus, metallic taste, anxiety, agitation, muscle twitching, drowsiness, respiratory depression, dizziness, nausea, vomiting, vision changes, paresthesias, perioral numbness, hypotension, arrhythmias, and cardiac arrest.
arm group label: Preservative free Chloroprocaine Group 1
arm group type: Active Comparator
description: 40 ml of preservative-free 1% chloroprocaine
arm group label: Preservative free Chloroprocaine Group 2
arm group type: Active Comparator
description: 40 ml of preservative-free 2% chloroprocaine
arm group label: Preservative free Chloroprocaine Group 3
arm group type: Active Comparator
description: 40 ml of preservative-free 3% chloroprocaine
intervention type: Drug
intervention name: Preservative free 1% Chloroprocaine
description: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
arm group label: Preservative free Chloroprocaine Group 1
other name: Nesacaine
intervention type: Drug
intervention name: Preservative free 2% Chloroprocaine
description: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
arm group label: Preservative free Chloroprocaine Group 2
other name: Nesacaine
intervention type: Drug
intervention name: Preservative free 3% Chloroprocaine
description: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
arm group label: Preservative free Chloroprocaine Group 3
other name: Nesacaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Brandon M Togioka, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
citation: Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.
PMID: 1118089
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Brandon M Togioka
investigator title: Principal Investigator
mesh term: Chloroprocaine
mesh term: Procaine
sharing ipd: No
provided document: 