<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/NCT03236298</url>
  </required_header>
  <id_info>
    <org_study_id>17-02</org_study_id>
    <nct_id>NCT03236298</nct_id>
  </id_info>
  <brief_title>Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow</brief_title>
  <official_title>Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: a RCT Comparing 125 mL/h Versus 250 mL/h Bolus Delivery Flow</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samuel Lunenfeld Research Institute, Mount Sinai Hospital</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>
      At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed&#xD;
      intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the&#xD;
      patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown&#xD;
      that delivering analgesia in this manner can prolong the duration of analgesia, diminish&#xD;
      motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and&#xD;
      decrease local anesthetic consumption comparing to a conventional continuous infusion. The&#xD;
      use of this PIEB technique in routine practice has reduced the total consumption of local&#xD;
      anesthetic and the percentage of patients requesting additional boluses (PCEA or manual&#xD;
      rescues).&#xD;
&#xD;
      However, at the same time, sensory blocks above those targeted for labor pain relief have&#xD;
      been reported in our institution, suggesting that the spread of the freezing medication is&#xD;
      wider than necessary. Based on the information already available in the literature, the&#xD;
      investigators will conduct this study to determine the best regimen of PIEB achievable with a&#xD;
      slower delivery speed.&#xD;
&#xD;
      The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the&#xD;
      incidence of women presenting sensory block to ice equal or higher than T6 as compared to a&#xD;
      delivery rate of 250 mL/h.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PIEB is a novel technique, which provides better analgesia and less motor block; however, the&#xD;
      ideal regimen has not been established. To optimize the PIEB regimen, the investigators have&#xD;
      conducted several clinical trials using bupivacaine with fentanyl. Although PIEB provides the&#xD;
      excellent analgesia to laboring parturients, studies completed by the instigators have shown&#xD;
      that the incidence of sensory block to ice ≥T6 was 66%. For labor analgesia during the first&#xD;
      stage of labor, effective sensory block requires T10 to L1; therefore, a sensory block ≥T6&#xD;
      seems unnecessarily high, and the investigators seek to confine epidural spread within a&#xD;
      proper range.&#xD;
&#xD;
      Our previous studies showed that the effective volume 90% using 0.0625% bupivacaine was 10.7&#xD;
      mL, and incidence of epidural blockade ≥T6 was similar even using a 5-mL bolus with 0.125%&#xD;
      bupivacaine. The investigators concluded that it is not possible to reduce volume of the&#xD;
      PIEB, or use a higher concentration of local anesthetic without compromising the quality of&#xD;
      analgesia. There is some evidence in the literature that supports the idea that higher&#xD;
      injection pressures result in a wider spread of local anesthetic administered into the&#xD;
      epidural space, therefore a slower epidural delivery flow rate may result in less spread.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">January 23, 2020</completion_date>
  <primary_completion_date type="Actual">January 22, 2020</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>Sensory block level to ice equal to or higher than T6 within the study period (6 hours)</measure>
    <time_frame>6 hours</time_frame>
    <description>Sensory block to ice will be assessed bilaterally at the mid-clavicular line, and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek). T6 is defined as the level of the xyphoid process.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensory block level to ice</measure>
    <time_frame>6 hours</time_frame>
    <description>Sensory block to ice will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block level to pin prick</measure>
    <time_frame>6 hours</time_frame>
    <description>Sensory block to pin prick will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient initial begins to feel normal sharp sensation compared to a control site (lateral upper arm, frontal part of head or cheek).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block level assessed using Bromage score</measure>
    <time_frame>6 hours</time_frame>
    <description>Motor block will be assessed hourly with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score</measure>
    <time_frame>6 hours</time_frame>
    <description>Pain score measured hourly (for up to 6 hours) using VNRS (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of PCEA demands</measure>
    <time_frame>6 hours</time_frame>
    <description>The number of times a patient presses the button to request additional analgesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of rescue boluses administered</measure>
    <time_frame>6 hours</time_frame>
    <description>The number of actual boluses administered by the patient, nurse or physician (for up to 6 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of local anesthetic (ml)</measure>
    <time_frame>6 hours</time_frame>
    <description>The total amount of local anesthetic consumption over the study period (by programmed intermittent bolus and any rescue boluses, for up to 6 hours).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal satisfaction rating</measure>
    <time_frame>6 hours</time_frame>
    <description>Maternal satisfaction rating using VNRS (0-10), 0=not at all satisfied, 10=most satisfied Rating at the end of the 6 hour study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>6 hours</time_frame>
    <description>A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural), during the 6 hour study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Labor Pain</condition>
  <arm_group>
    <arm_group_label>PIEB speed of infusion 250 ml/hr</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 250 ml/hr by the CADD-Solis Ambulatory Infusion System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIEB speed of infusion 125 ml/hr</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 125 ml/hr by the CADD-Solis Ambulatory Infusion System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CADD-Solis Ambulatory Infusion System</intervention_name>
    <description>The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.</description>
    <arm_group_label>PIEB speed of infusion 125 ml/hr</arm_group_label>
    <arm_group_label>PIEB speed of infusion 250 ml/hr</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA II or III&#xD;
&#xD;
          -  Term pregnancy (gestational age ≥ 37 weeks)&#xD;
&#xD;
          -  Nulliparous&#xD;
&#xD;
          -  Singleton pregnancy with vertex presentation&#xD;
&#xD;
          -  Active labour defined as occurring regular uterine contractions at least every 5&#xD;
             minutes with progressive cervical dilatation&#xD;
&#xD;
          -  Verbal Numerical Rating Score (VNRS) greater than 5 at requiring epidural analgesia&#xD;
             (VNRS 0-10)&#xD;
&#xD;
          -  Cervical dilation between 2 and 5 cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindication to epidural analgesia&#xD;
&#xD;
          -  Accidental dural puncture&#xD;
&#xD;
          -  Drug allergy to lidocaine, bupivacaine or fentanyl&#xD;
&#xD;
          -  Use of pharmacological analgesics within the last 4 hours&#xD;
&#xD;
          -  Patient refusal to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose CA Carvalho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epidural</keyword>
  <keyword>Labor analgesia</keyword>
  <keyword>Programmed intermittent epidural bolus</keyword>
  <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>
  </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/NCT03236298
org study id: 17-02
nct id: NCT03236298
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
At Mount Sinai Hospital, epidural analgesia for labor pain is delivered by programmed
      intermittent epidural bolus (PIEB), in combination with pushes of medication activated by the
      patient, a technique called patient controlled epidural analgesia (PCEA). Studies have shown
      that delivering analgesia in this manner can prolong the duration of analgesia, diminish
      motor block, lower the incidence of breakthrough pain, improve maternal satisfaction and
      decrease local anesthetic consumption comparing to a conventional continuous infusion. The
      use of this PIEB technique in routine practice has reduced the total consumption of local
      anesthetic and the percentage of patients requesting additional boluses (PCEA or manual
      rescues).

      However, at the same time, sensory blocks above those targeted for labor pain relief have
      been reported in our institution, suggesting that the spread of the freezing medication is
      wider than necessary. Based on the information already available in the literature, the
      investigators will conduct this study to determine the best regimen of PIEB achievable with a
      slower delivery speed.

      The hypothesis of this study is that PIEB boluses with 125 mL/h will decrease by 50% the
      incidence of women presenting sensory block to ice equal or higher than T6 as compared to a
      delivery rate of 250 mL/h.
PIEB is a novel technique, which provides better analgesia and less motor block; however, the
      ideal regimen has not been established. To optimize the PIEB regimen, the investigators have
      conducted several clinical trials using bupivacaine with fentanyl. Although PIEB provides the
      excellent analgesia to laboring parturients, studies completed by the instigators have shown
      that the incidence of sensory block to ice ≥T6 was 66%. For labor analgesia during the first
      stage of labor, effective sensory block requires T10 to L1; therefore, a sensory block ≥T6
      seems unnecessarily high, and the investigators seek to confine epidural spread within a
      proper range.

      Our previous studies showed that the effective volume 90% using 0.0625% bupivacaine was 10.7
      mL, and incidence of epidural blockade ≥T6 was similar even using a 5-mL bolus with 0.125%
      bupivacaine. The investigators concluded that it is not possible to reduce volume of the
      PIEB, or use a higher concentration of local anesthetic without compromising the quality of
      analgesia. There is some evidence in the literature that supports the idea that higher
      injection pressures result in a wider spread of local anesthetic administered into the
      epidural space, therefore a slower epidural delivery flow rate may result in less spread.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Sensory block level to ice equal to or higher than T6 within the study period (6 hours)
time frame: 6 hours
description: Sensory block to ice will be assessed bilaterally at the mid-clavicular line, and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek). T6 is defined as the level of the xyphoid process.
measure: Sensory block level to ice
time frame: 6 hours
description: Sensory block to ice will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient still does not feel normal cold sensation as compared to a control site (lateral upper arm, frontal part of head or cheek).
measure: Sensory block level to pin prick
time frame: 6 hours
description: Sensory block to pin prick will be assessed bilaterally at the mid-clavicular line hourly (for up to 6 hours), and the level of block will be the level at which the patient initial begins to feel normal sharp sensation compared to a control site (lateral upper arm, frontal part of head or cheek).
measure: Motor block level assessed using Bromage score
time frame: 6 hours
description: Motor block will be assessed hourly with the Bromage score: 0 = able to raise the extended leg; 1 = unable to raise the extended leg but able to flex knees; 2 = unable to flex knees, but able to flex ankle; 3 = unable to flex ankle.
measure: Pain score
time frame: 6 hours
description: Pain score measured hourly (for up to 6 hours) using VNRS (0-10)
measure: Total number of PCEA demands
time frame: 6 hours
description: The number of times a patient presses the button to request additional analgesia.
measure: Total number of rescue boluses administered
time frame: 6 hours
description: The number of actual boluses administered by the patient, nurse or physician (for up to 6 hours).
measure: Total amount of local anesthetic (ml)
time frame: 6 hours
description: The total amount of local anesthetic consumption over the study period (by programmed intermittent bolus and any rescue boluses, for up to 6 hours).
measure: Maternal satisfaction rating
time frame: 6 hours
description: Maternal satisfaction rating using VNRS (0-10), 0=not at all satisfied, 10=most satisfied Rating at the end of the 6 hour study period.
measure: Hypotension
time frame: 6 hours
description: A decrease in systolic blood pressure greater than 20% from baseline (defined as an average of 3 readings prior to epidural), during the 6 hour study period.
arm group label: PIEB speed of infusion 250 ml/hr
arm group type: Active Comparator
description: The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 250 ml/hr by the CADD-Solis Ambulatory Infusion System.
arm group label: PIEB speed of infusion 125 ml/hr
arm group type: Active Comparator
description: The programmed intermittent bolus of 10ml will be administered every 40 minutes, at a speed of 125 ml/hr by the CADD-Solis Ambulatory Infusion System.
intervention type: Device
intervention name: CADD-Solis Ambulatory Infusion System
description: The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
arm group label: PIEB speed of infusion 125 ml/hr
arm group label: PIEB speed of infusion 250 ml/hr
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose CA Carvalho, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Labor Pain
sharing ipd: No