<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/NCT03790124</url>
  </required_header>
  <id_info>
    <org_study_id>1218545</org_study_id>
    <nct_id>NCT03790124</nct_id>
  </id_info>
  <brief_title>Post-dural Puncture Headache: A Retrospective Study</brief_title>
  <official_title>Effectiveness of a Multimodal Prophylactic Strategy to Treat Post-dural Puncture Headache: A Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neuraxial techniques are widely used in obstetric practice to provide analgesia and&#xD;
      anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture&#xD;
      headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during&#xD;
      insertion of an epidural needle. Incidence of PDPH after spinal anesthesia is very low due to&#xD;
      the widespread use of non-cutting small diameter spinal needles. Incidence of &quot;wet tap&quot;&#xD;
      during epidural injection has been reported to be 1.5%, with 52-85% of these patients&#xD;
      developing PDPH.&#xD;
&#xD;
      When an obstetric patient develops PDPH, institution of an effective treatment is necessary.&#xD;
      Although PDPH tends to resolve spontaneously over a couple of weeks, it carries the risk of&#xD;
      potential complications. PDPH interfere with the ability of the mother to take care of her&#xD;
      baby, increases the risk of chronic headache and limits early ambulation, thereby increasing&#xD;
      the risk of venous thrombosis and pulmonary embolism. As important as treating PDPH when it&#xD;
      occurs is to prevent it when the dura is accidentally punctured during labor epidural&#xD;
      placement. Multiple therapeutic strategies have been reported in the medical literature to&#xD;
      prevent this outcome. Preventive measures range from conservative strategies to invasive&#xD;
      procedures. Bedrest and hydration have been traditionally recommended to try to prevent PDPH&#xD;
      when a wet tap occurs; however, no conclusive evidence supports their use. The use of oral&#xD;
      and intravenous caffeine is insufficiently supported by clinical evidence. Epidural morphine&#xD;
      and intravenous cosyntropin have been successfully used to prevent PDPH. Epidural injection&#xD;
      of normal saline reduces the gradient for CSF leak. The use of saline has shown variable&#xD;
      results in different studies. Although the results of some studies show insufficient evidence&#xD;
      about its effectiveness, administration of epidural saline is a technique relatively devoid&#xD;
      of significant adverse effects.&#xD;
&#xD;
      The institutional protocol recommends the combination of a multimodal approach to prevention&#xD;
      of PDPH after accidental dural puncture, based on strategies reported in the medical&#xD;
      literature. The protocol consists of the immediate administration of 60 cc of epidural normal&#xD;
      saline, followed by two preventive measures administered after delivery. After delivery, 1 mg&#xD;
      of intravenous cosyntropin and 3 mg of epidural morphine before catheter removal are&#xD;
      administered. This study tests the hypothesis that the multimodal prophylactic protocol&#xD;
      described above decreases the incidence of PDPH and the need to perform epidural blood patch,&#xD;
      compared to other strategies or no prophylactic management.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of cases with Postdural puncture headache</measure>
    <time_frame>3 days after delivery</time_frame>
    <description>Number of patients who had wet tap during epidural placement who developed postdural puncture headache</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of cases of epidural patch placement</measure>
    <time_frame>3 days after delivery</time_frame>
    <description>Number of patients who had wet tap during epidural placement who developed postdural puncture and required performance of epidural blood patch</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Obstetric Anesthesia Problems</condition>
  <condition>Headache</condition>
  <condition>Epidural; Anesthesia, Headache</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant patients who underwent labor epidural analgesia and had accidental dural puncture&#xD;
        (wet tap)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients who underwent labor epidural and had accidental dural puncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of migraines or chronic headaches&#xD;
&#xD;
          -  History of neurological deficits&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Efrain Riveros Perez, MD</investigator_full_name>
    <investigator_title>Assistant Professor. Department of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Dural Puncture Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03790124
org study id: 1218545
nct id: NCT03790124
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neuraxial techniques are widely used in obstetric practice to provide analgesia and
      anesthesia. A common complication associated with neuraxial anesthesia is post-dural puncture
      headache (PDPH), resulting from unintentional or unintended puncture of the dura mater during
      insertion of an epidural needle. Incidence of PDPH after spinal anesthesia is very low due to
      the widespread use of non-cutting small diameter spinal needles. Incidence of "wet tap"
      during epidural injection has been reported to be 1.5%, with 52-85% of these patients
      developing PDPH.

      When an obstetric patient develops PDPH, institution of an effective treatment is necessary.
      Although PDPH tends to resolve spontaneously over a couple of weeks, it carries the risk of
      potential complications. PDPH interfere with the ability of the mother to take care of her
      baby, increases the risk of chronic headache and limits early ambulation, thereby increasing
      the risk of venous thrombosis and pulmonary embolism. As important as treating PDPH when it
      occurs is to prevent it when the dura is accidentally punctured during labor epidural
      placement. Multiple therapeutic strategies have been reported in the medical literature to
      prevent this outcome. Preventive measures range from conservative strategies to invasive
      procedures. Bedrest and hydration have been traditionally recommended to try to prevent PDPH
      when a wet tap occurs; however, no conclusive evidence supports their use. The use of oral
      and intravenous caffeine is insufficiently supported by clinical evidence. Epidural morphine
      and intravenous cosyntropin have been successfully used to prevent PDPH. Epidural injection
      of normal saline reduces the gradient for CSF leak. The use of saline has shown variable
      results in different studies. Although the results of some studies show insufficient evidence
      about its effectiveness, administration of epidural saline is a technique relatively devoid
      of significant adverse effects.

      The institutional protocol recommends the combination of a multimodal approach to prevention
      of PDPH after accidental dural puncture, based on strategies reported in the medical
      literature. The protocol consists of the immediate administration of 60 cc of epidural normal
      saline, followed by two preventive measures administered after delivery. After delivery, 1 mg
      of intravenous cosyntropin and 3 mg of epidural morphine before catheter removal are
      administered. This study tests the hypothesis that the multimodal prophylactic protocol
      described above decreases the incidence of PDPH and the need to perform epidural blood patch,
      compared to other strategies or no prophylactic management.
observational model: Other
time perspective: Retrospective
measure: Number of cases with Postdural puncture headache
time frame: 3 days after delivery
description: Number of patients who had wet tap during epidural placement who developed postdural puncture headache
measure: Number of cases of epidural patch placement
time frame: 3 days after delivery
description: Number of patients who had wet tap during epidural placement who developed postdural puncture and required performance of epidural blood patch
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Efrain Riveros Perez, MD
investigator title: Assistant Professor. Department of Anesthesiology
mesh term: Post-Dural Puncture Headache
mesh term: Headache
sharing ipd: Undecided