xml: <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/NCT05977361</url>
    </required_header>
    <id_info>
      <org_study_id>ItaREVI</org_study_id>
      <nct_id>NCT05977361</nct_id>
    </id_info>
    <brief_title>Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients</brief_title>
    <acronym>ItaREVI</acronym>
    <official_title>Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients: a Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Epidural anesthesia represents the most popular method for pain relief during labour.&#xD;
        Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia,&#xD;
        representing therefore the most common complication. Up to 80% of patients with a UDP may&#xD;
        develop a post-dural puncture headache (PDPH).&#xD;
  &#xD;
        When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia&#xD;
        during labour: either resiting the epidural catheter in a different intervertebral space, or&#xD;
        inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during&#xD;
        labour, but their relative contribution in preventing PDPH is still not known.&#xD;
  &#xD;
        The primary aim of this multicenter randomized controlled trial is therefore to compare these&#xD;
        two strategies in the occurrence of PDPH at 24 hours from the UDP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>PDPH incidence</measure>
      <time_frame>At 24 hours from UDP</time_frame>
      <description>Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PDPH intensity at 24 hours</measure>
      <time_frame>At 24 hours from UDP</time_frame>
      <description>PDPH intensity, rated using a 10-point scale, ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst pain imaginable&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PDPH intensity at 48 hours</measure>
      <time_frame>At 48 hours from UDP</time_frame>
      <description>PDPH intensity, rated using a 10-point scale, ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst pain imaginable&quot;)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of analgesia</measure>
      <time_frame>During the entire course of labour, an average of 12 hours</time_frame>
      <description>Quality of analgesia during labour will be evaluated, based on the number of additional boluses of local anesthetic administered during labour to treat breakthrough pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>During the entire follow-up period, up to 3 months from UDP</time_frame>
      <description>All reported adverse events, including number of unsuccessful attempts at placing the epidural or subarachnoid catheter, motor block, poor analgesia, caesarean section rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chronic pain at 1 month</measure>
      <time_frame>At 1 month from UDP</time_frame>
      <description>Incidence of chronic headache and chronic low back pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chronic pain at 3 months</measure>
      <time_frame>At 3 months from UDP</time_frame>
      <description>Incidence of chronic headache and chronic low back pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission to hospital</measure>
      <time_frame>Up to 3 months from UDP</time_frame>
      <description>ER visits or hospital readmissions due to neurological symptoms related or possibly related to PDPH (severe headache, severe back pain, fever, leg weakness, incontinence of urine or stool)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's satisfaction</measure>
      <time_frame>Before discharge, an average of 1 week</time_frame>
      <description>Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">181</enrollment>
    <condition>Analgesia, Obstetrical</condition>
    <condition>Post-Dural Puncture Headache</condition>
    <arm_group>
      <arm_group_label>Resiting Epidural Catheter</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Intrathecal catheter placement</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Resiting Epidural Catheter</intervention_name>
      <description>After a UDP has occurred, epidural catheter will be re-sited in a different intervertebral space. Analgesia will be then maintained according to internal protocol, using PIEB (Programmed Intermittent Epidural Bolus) system. Catheter will be left in place for the first 24-36 hours.</description>
      <arm_group_label>Resiting Epidural Catheter</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intrathecal Catheter Placement</intervention_name>
      <description>After a UDP has occurred, an intrathecal catheter will be placed through the dural tap. Analgesia will be then maintained according to internal protocol, using PISB (Programmed Intermittent Subarachnoid Bolus) system. Catheter will be left in place for the first 24-36 hours. During this time, a continuous infusion of sterile saline at a rate of 2 mL/h will be maintained. Before removal, an additional bolus of 10 mL of sterile saline will be administered in the intrathecal catheter.</description>
      <arm_group_label>Intrathecal catheter placement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Confirmed diagnosis of UDP during labour&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate in the study&#xD;
  &#xD;
            -  History of PDPH&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bruno A Zanfini, MD, PhD</last_name>
      <phone>06 3015 3105</phone>
      <email>brunoantonio.zanfini@policlinicogemelli.it</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Labor Pain</keyword>
    <keyword>Obstetric Labor Complications</keyword>
    <keyword>Analgesia, Epidural</keyword>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977361
  org study id: ItaREVI
  nct id: NCT05977361
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Epidural anesthesia represents the most popular method for pain relief during labour.
        Unintentional dural puncture (UDP) occurs in 0.4-1.5% of labour epidural analgesia,
        representing therefore the most common complication. Up to 80% of patients with a UDP may
        develop a post-dural puncture headache (PDPH).
  
        When a UDP occurs, two possible strategies have been proposed in order to ensure analgesia
        during labour: either resiting the epidural catheter in a different intervertebral space, or
        inserting an intrathecal catheter. Both strategies proved to equally provide analgesia during
        labour, but their relative contribution in preventing PDPH is still not known.
  
        The primary aim of this multicenter randomized controlled trial is therefore to compare these
        two strategies in the occurrence of PDPH at 24 hours from the UDP.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: PDPH incidence
  time frame: At 24 hours from UDP
  description: Incidence of post-dural puncture headache (PDPH) at 24 hours from UDP occurrence
  measure: PDPH intensity at 24 hours
  time frame: At 24 hours from UDP
  description: PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
  measure: PDPH intensity at 48 hours
  time frame: At 48 hours from UDP
  description: PDPH intensity, rated using a 10-point scale, ranging from 0 ("no pain") to 10 ("worst pain imaginable")
  measure: Quality of analgesia
  time frame: During the entire course of labour, an average of 12 hours
  description: Quality of analgesia during labour will be evaluated, based on the number of additional boluses of local anesthetic administered during labour to treat breakthrough pain.
  measure: Adverse events
  time frame: During the entire follow-up period, up to 3 months from UDP
  description: All reported adverse events, including number of unsuccessful attempts at placing the epidural or subarachnoid catheter, motor block, poor analgesia, caesarean section rate.
  measure: Chronic pain at 1 month
  time frame: At 1 month from UDP
  description: Incidence of chronic headache and chronic low back pain
  measure: Chronic pain at 3 months
  time frame: At 3 months from UDP
  description: Incidence of chronic headache and chronic low back pain
  measure: Readmission to hospital
  time frame: Up to 3 months from UDP
  description: ER visits or hospital readmissions due to neurological symptoms related or possibly related to PDPH (severe headache, severe back pain, fever, leg weakness, incontinence of urine or stool)
  measure: Patient's satisfaction
  time frame: Before discharge, an average of 1 week
  description: Patient's satisfaction, evaluated through the Italian version of the Birth Satisfaction Scale-Revised (BSS-R)
  arm group label: Resiting Epidural Catheter
  arm group type: Active Comparator
  arm group label: Intrathecal catheter placement
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Resiting Epidural Catheter
  description: After a UDP has occurred, epidural catheter will be re-sited in a different intervertebral space. Analgesia will be then maintained according to internal protocol, using PIEB (Programmed Intermittent Epidural Bolus) system. Catheter will be left in place for the first 24-36 hours.
  arm group label: Resiting Epidural Catheter
  intervention type: Procedure
  intervention name: Intrathecal Catheter Placement
  description: After a UDP has occurred, an intrathecal catheter will be placed through the dural tap. Analgesia will be then maintained according to internal protocol, using PISB (Programmed Intermittent Subarachnoid Bolus) system. Catheter will be left in place for the first 24-36 hours. During this time, a continuous infusion of sterile saline at a rate of 2 mL/h will be maintained. Before removal, an additional bolus of 10 mL of sterile saline will be administered in the intrathecal catheter.
  arm group label: Intrathecal catheter placement
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Bruno A Zanfini, MD, PhD
  phone: 06 3015 3105
  email: brunoantonio.zanfini@policlinicogemelli.it
  responsible party type: Sponsor
  mesh term: Post-Dural Puncture Headache
  mesh term: Headache
  sharing ipd: No