<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/NCT03043781</url>
  </required_header>
  <id_info>
    <org_study_id>2015-004397-14</org_study_id>
    <nct_id>NCT03043781</nct_id>
  </id_info>
  <brief_title>The Programmed Intermittent Epidural Bolus Adrenaline Study</brief_title>
  <acronym>PIEBA</acronym>
  <official_title>The Programmed Intermittent Epidural Bolus Adrenaline Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Akershus</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the use of intermittent epidural boluses compared to continuous infusion&#xD;
      in maintaining epidural pain relief in labor.&#xD;
&#xD;
      The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in&#xD;
      both groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Labor is often painful for the woman going through it, and thus many women choose to have&#xD;
      pain relief by an epidural catheter.&#xD;
&#xD;
      This is done by placing a thin plastic catheter in the epidural space in the lower back of&#xD;
      the patient, and injecting a medicine solution usually consisting of local anesthesia and&#xD;
      opioids.&#xD;
&#xD;
      To ensure an effective pain relief through the labor process, additional medicine solution is&#xD;
      injected through the catheter. Traditionally, this is done by a continuous infusion, often&#xD;
      with the addition of patient controlled boluses.&#xD;
&#xD;
      In this study the investigators investigate if maintaining the pain relief through programmed&#xD;
      hourly intermittent boluses is more effective than continuous infusion. This is done in other&#xD;
      studies with promising results, but the difference in this study is the addition of&#xD;
      adrenaline to the medicine solution in order to make it more effective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">September 5, 2018</completion_date>
  <primary_completion_date type="Actual">September 5, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative drug consumption, time adjusted</measure>
    <time_frame>One assessment, within 24 hours of end of treatment</time_frame>
    <description>Cumulative drug consumption is assessed at the end of treatment (at birth). The total dose is adjusted for differences in treatment time and other possible factors of influence (BMI, parity, age, gestational age etc.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal satisfaction with treatment</measure>
    <time_frame>One assessment, within 24 hours of end of treatment</time_frame>
    <description>Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>One assessment, within 24 hours of end of treatment</time_frame>
    <description>Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block</measure>
    <time_frame>One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.</time_frame>
    <description>Extent of lower extremity motor block will be assessed using a modified Bromage score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthesiologic intervention</measure>
    <time_frame>During treatment (0-24 hours)</time_frame>
    <description>The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of expected adverse events</measure>
    <time_frame>Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment</time_frame>
    <description>Expected adverse events include hypotension (systolic blood pressure &lt; 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain rating</measure>
    <time_frame>During treatment (0-24 hours)</time_frame>
    <description>Pain rating will be assessed using a numeric rating scale (NRS, 0-10; 0= no pain, 10=worst imaginable pain) before treatment start, at every hour for the first 8 hours of treatment and every other hour thereafter. Worst pain at delivery will also be assessed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>Intermittent epidural bolus (IEB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bolus of 5 ml every hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous epidural infusion (CEI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous epidural infusion of 5 ml / hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continuous epidural infusion</intervention_name>
    <description>Continuous infusion, 5 ml/h</description>
    <arm_group_label>Continuous epidural infusion (CEI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermittent epidural bolus</intervention_name>
    <description>Intermittent bolus 5 ml every hour</description>
    <arm_group_label>Intermittent epidural bolus (IEB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in labor requesting epidural analgesia&#xD;
&#xD;
          -  ASA group 1 and 2&#xD;
&#xD;
          -  0 or 1 previous births&#xD;
&#xD;
          -  Must be at least 18 years of age.&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Active labor&#xD;
&#xD;
          -  Signed informed consent and expected cooperation of the patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor communication skills in norwegian or english&#xD;
&#xD;
          -  Adverse reactions to local anesthetics or synthetic opioids&#xD;
&#xD;
          -  Body height below 150 cm&#xD;
&#xD;
          -  Gestational age below 37 weeks, 0 days&#xD;
&#xD;
          -  Any contraindication to epidural catheter placement (e.g. patients with coagulopathy,&#xD;
             infection in area etc)&#xD;
&#xD;
          -  Pre-eclampsia&#xD;
&#xD;
          -  Sound reason by the investigator to suspect patient non-compliance (e.g. with use of&#xD;
             PCEA)&#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_official>
    <last_name>Vegard Dahl, MD, Dr. Med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus UH</name>
      <address>
        <city>Lørenskog</city>
        <state>Akershus</state>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. Erratum In: Anesth Analg. 2013 Jun;116(6):1385.</citation>
    <PMID>23223119</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Vegard Dahl</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Labor Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual participant data.</ipd_description>
  </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/NCT03043781
org study id: 2015-004397-14
nct id: NCT03043781
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study evaluates the use of intermittent epidural boluses compared to continuous infusion
      in maintaining epidural pain relief in labor.

      The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in
      both groups.
Labor is often painful for the woman going through it, and thus many women choose to have
      pain relief by an epidural catheter.

      This is done by placing a thin plastic catheter in the epidural space in the lower back of
      the patient, and injecting a medicine solution usually consisting of local anesthesia and
      opioids.

      To ensure an effective pain relief through the labor process, additional medicine solution is
      injected through the catheter. Traditionally, this is done by a continuous infusion, often
      with the addition of patient controlled boluses.

      In this study the investigators investigate if maintaining the pain relief through programmed
      hourly intermittent boluses is more effective than continuous infusion. This is done in other
      studies with promising results, but the difference in this study is the addition of
      adrenaline to the medicine solution in order to make it more effective.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cumulative drug consumption, time adjusted
time frame: One assessment, within 24 hours of end of treatment
description: Cumulative drug consumption is assessed at the end of treatment (at birth). The total dose is adjusted for differences in treatment time and other possible factors of influence (BMI, parity, age, gestational age etc.)
measure: Maternal satisfaction with treatment
time frame: One assessment, within 24 hours of end of treatment
description: Overall satisfaction with treatment will be assessed the day after end of treatment on a 0-10 scale.
measure: Mode of delivery
time frame: One assessment, within 24 hours of end of treatment
description: Mode of delivery will be assessed and categorized as vaginal,instrumentally assisted or cesarean delivery.
measure: Motor block
time frame: One assessment at one hour after treatment initiation and one at 10 cm cervical dilatation.
description: Extent of lower extremity motor block will be assessed using a modified Bromage score
measure: Anesthesiologic intervention
time frame: During treatment (0-24 hours)
description: The need for additional anesthesiologic intervention, including time to this intervention from start of treatment.
measure: Incidence of expected adverse events
time frame: Adverse events during treatment (0-24 hours) and final assessment within 24 hours of end of treatment
description: Expected adverse events include hypotension (systolic blood pressure < 90 mmHg and/or use of vasopressors), nausea (mild/moderate/severe) and pruritus (mild/moderate/severe).
measure: Pain rating
time frame: During treatment (0-24 hours)
description: Pain rating will be assessed using a numeric rating scale (NRS, 0-10; 0= no pain, 10=worst imaginable pain) before treatment start, at every hour for the first 8 hours of treatment and every other hour thereafter. Worst pain at delivery will also be assessed.
arm group label: Intermittent epidural bolus (IEB)
arm group type: Experimental
description: Bolus of 5 ml every hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.
arm group label: Continuous epidural infusion (CEI)
arm group type: Active Comparator
description: Continuous epidural infusion of 5 ml / hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.
intervention type: Other
intervention name: Continuous epidural infusion
description: Continuous infusion, 5 ml/h
arm group label: Continuous epidural infusion (CEI)
intervention type: Other
intervention name: Intermittent epidural bolus
description: Intermittent bolus 5 ml every hour
arm group label: Intermittent epidural bolus (IEB)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vegard Dahl, MD, Dr. Med.
role: Principal Investigator
affiliation: University Hospital, Akershus
facility: 
country: Norway
citation: George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. Erratum In: Anesth Analg. 2013 Jun;116(6):1385.
PMID: 23223119
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Vegard Dahl
investigator title: Principal investigator
mesh term: Labor Pain
sharing ipd: No
ipd description: No plan to share individual participant data.