<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/NCT01682967</url>
  </required_header>
  <id_info>
    <org_study_id>AHEAD-11</org_study_id>
    <nct_id>NCT01682967</nct_id>
  </id_info>
  <brief_title>Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients</brief_title>
  <acronym>AHEAD</acronym>
  <official_title>Alteration in Hearing Following Accidental Dural Puncture. A Study in Parturients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Örebro University, Sweden</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Headache following accidental dural punction as during epidural analgesia can be severe and&#xD;
      sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural&#xD;
      puncture. Although spontaneous resolution of headaches is common in most patients within 7&#xD;
      days, in 20% can they be persistent and in some very disabling. The exact reason for the&#xD;
      characteristic headache is unknown, but it is believed to be the result of leakage of&#xD;
      cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more&#xD;
      severe and persistent the headache. This is why larger needles (lower gauge) are known to&#xD;
      have a higher incidence of PDPH. However, the type of needle also seems to play an important&#xD;
      role in the likelihood of PDPH.&#xD;
&#xD;
      Headache following accidental PDPH is very typical as it increases significantly when sitting&#xD;
      or standing and often disappears completely on lying down. It is typically located in the&#xD;
      back of the head, accentuated by light and often decreases with intake of large quantity of&#xD;
      fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.&#xD;
&#xD;
      Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage,&#xD;
      as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing&#xD;
      that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the&#xD;
      hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of&#xD;
      clinical symptoms and signs of accidental PDPH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parturients who have received epidural analgesia during labour would be included in this&#xD;
      study and these would comprise of:&#xD;
&#xD;
        1. patients without clinical symptoms of postdural puncture headache&#xD;
&#xD;
        2. patients with clinical symptoms of postdural puncture headache&#xD;
&#xD;
      In addition, a control group of parturients who have not received an epidural analgesia would&#xD;
      constitute the control group.&#xD;
&#xD;
      All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state&#xD;
      response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be&#xD;
      observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry&#xD;
      would be done at this stage. Those patients with substantial evidence of PDPH at this stage&#xD;
      would receive an epidural blood patch (EBP) and a new audiometric assessment would be made&#xD;
      after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All&#xD;
      patients would have a similar measurement of hearing after 3 months when it is believed that&#xD;
      most patients have returned to normal hearing. In addition to audiometric analysis, patients&#xD;
      would be asked to fill out a detailed PDPH questionnaire at the same time periods.&#xD;
&#xD;
      All measurements would be compared with patients who have received an EDA but without PDPH&#xD;
      and those who have not received an EDA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Post-dural puncture headache</measure>
    <time_frame>4 h after epidural blood patch</time_frame>
    <description>VAS pain (headache) 4 h after application of EBP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Audiometric data</measure>
    <time_frame>4 h following EBP</time_frame>
    <description>OAE and ASSR would be measured 4 h after application of EBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PDPH questionnaire</measure>
    <time_frame>4 h after application of EBP</time_frame>
    <description>The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Headache</measure>
    <time_frame>24 h after application of EBP</time_frame>
    <description>The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Parturients in Labour</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <description>Patients suffering from PDPH would form this group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group - Epidural</arm_group_label>
    <description>Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group without Epidural analgesia</arm_group_label>
    <description>Patients in labour who did not receive an EDA would form this cohort of controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Experimental group: Parturients in labour with epidural and having PDPH Control group -&#xD;
        EDA: Parturients in labour with epidural and NOT having PDPH Control group - No EDA:&#xD;
        Parturients in labour without epidural and NOT having PDPH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy parturients No known hearing problems Understand Swedish language Informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking steroid medication Having pre-eclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Karolinskasjukhuset</name>
      <address>
        <city>Solna</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Örebro</city>
        <zip>701 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>September 26, 2015</last_update_submitted>
  <last_update_submitted_qc>September 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro University, Sweden</investigator_affiliation>
    <investigator_full_name>Anil Gupta</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Parturients</keyword>
  <keyword>Analgesia, epidural</keyword>
  <keyword>Headache, post-dural puncture</keyword>
  <!-- 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/NCT01682967
org study id: AHEAD-11
nct id: NCT01682967
lead sponsor: 
collaborator: 
has dmc: Yes
Headache following accidental dural punction as during epidural analgesia can be severe and
      sometimes very disabling. The incidence of PDPH is 10-40%, most starting within 48 h of dural
      puncture. Although spontaneous resolution of headaches is common in most patients within 7
      days, in 20% can they be persistent and in some very disabling. The exact reason for the
      characteristic headache is unknown, but it is believed to be the result of leakage of
      cerebro-spinal fluid (CSF) from the dural puncture. The greater the leakage of CSF, the more
      severe and persistent the headache. This is why larger needles (lower gauge) are known to
      have a higher incidence of PDPH. However, the type of needle also seems to play an important
      role in the likelihood of PDPH.

      Headache following accidental PDPH is very typical as it increases significantly when sitting
      or standing and often disappears completely on lying down. It is typically located in the
      back of the head, accentuated by light and often decreases with intake of large quantity of
      fluids. In many cases, it is self-limiting and most often decreases with time and bed rest.

      Diagnosis of PDPH is clinical and sometimes difficult. It is well known that liquor leakage,
      as following spinal anaesthesia, results in partial loss of unilateral or bilateral hearing
      that can be detected by oto-acoustic hearing loss. We plan to use this knowledge and test the
      hypothesis that measurement of hearing loss may be a diagnostic method for confirmation of
      clinical symptoms and signs of accidental PDPH.
Parturients who have received epidural analgesia during labour would be included in this
      study and these would comprise of:

        1. patients without clinical symptoms of postdural puncture headache

        2. patients with clinical symptoms of postdural puncture headache

      In addition, a control group of parturients who have not received an epidural analgesia would
      constitute the control group.

      All patients would have audiometry (oto-acoustic emission - OAE, and auditory steady state
      response - ASSR) done following diagnosis of PDPH. Subsequently, the patients would be
      observed for 24 h to assess whether the headache resolves spontaneously. A new audiometry
      would be done at this stage. Those patients with substantial evidence of PDPH at this stage
      would receive an epidural blood patch (EBP) and a new audiometric assessment would be made
      after 4 h and 24 h to assess whether any audiometric deficit has resolved or not. All
      patients would have a similar measurement of hearing after 3 months when it is believed that
      most patients have returned to normal hearing. In addition to audiometric analysis, patients
      would be asked to fill out a detailed PDPH questionnaire at the same time periods.

      All measurements would be compared with patients who have received an EDA but without PDPH
      and those who have not received an EDA.
observational model: Case-Control
time perspective: Prospective
measure: Post-dural puncture headache
time frame: 4 h after epidural blood patch
description: VAS pain (headache) 4 h after application of EBP
measure: Audiometric data
time frame: 4 h following EBP
description: OAE and ASSR would be measured 4 h after application of EBP
measure: PDPH questionnaire
time frame: 4 h after application of EBP
description: The PDPH questionnaire would be used to analyse pain and its characteristics 4 h after application of EBP
measure: Recurrence of Headache
time frame: 24 h after application of EBP
description: The incidence of recurrence of PDPH after initial improvement on application of EBP would be recorded after 24 h
arm group label: Experimental group
description: Patients suffering from PDPH would form this group
arm group label: Control group - Epidural
description: Patients who received an epidural during labour but did not have symptoms of PDPH would form this reference group
arm group label: Control Group without Epidural analgesia
description: Patients in labour who did not receive an EDA would form this cohort of controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Örebro University, Sweden
investigator full name: Anil Gupta
investigator title: Associate Professor