<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/NCT03839056</url>
  </required_header>
  <id_info>
    <org_study_id>MAR-ROP-2015-01</org_study_id>
    <nct_id>NCT03839056</nct_id>
  </id_info>
  <brief_title>Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia</brief_title>
  <official_title>Comparative Study of the Combination of Different Modes of Administration of Local Anesthetics in Labor Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marian Daras</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario de la Plana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</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>
      The investigators have design an observational study to know the anesthetic consumption in&#xD;
      terms of rescue analgesia (Patient Controlled Epidural Analgesia (PCEA) and manual boluses)&#xD;
      of the combination of different modes of administration of local anesthetic in the epidural&#xD;
      space during labor analgesia offered by the new version of the CADD® infusion pump.&#xD;
&#xD;
      Also in this pump the anesthetic can be administered across a system of standard flow&#xD;
      (40-250ml/h) or of high flow (40-500ml/h), what according to studies can influence the&#xD;
      diffusion epidural of the anesthetic and therefore the level of sensitive blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed with healthy patients, first-time mothers, in childbearing dynamics,&#xD;
      term pregnancy and nullipary. The epidural technique was performed with dose test of 3ml of&#xD;
      bupivacaína 0,25 % with vasoconstrictor and a manual bolus of 0,1ml/Kg of ropivacaína 0,2%&#xD;
      with fentanilo 5ug/ml.&#xD;
&#xD;
      As soon as the informed consent about the epidural anesthesia was signed, the patient was&#xD;
      informed of the possibility of taking part in the study and there is offered him the sheet of&#xD;
      information of the patient. So in one group they were administered Programed Intermittent&#xD;
      Epidural Boluses (PIEB) and in other group continuous Epidural Infusion (IC) plus PIEB&#xD;
      according to the usual clinical practice of each anesthesiologist. In both cases the&#xD;
      perfusion was of ropivacaína 0,1 % more fentanilo 2ug/ml, so that in the first group it was&#xD;
      administered PIEB of 10ml every hour and in the second group a continuous infusion to 3ml/h&#xD;
      plus PIEB of 7ml every hour. Also if during the period of dilatation an AVE (Analogical&#xD;
      Visual Escale) greater than or equal to 4 appeared (inadequate analgesia) the patient could&#xD;
      administer a 5ml PCEA bolus of the same solution (interval of closing of 20min and maximum&#xD;
      dose for hour of 15ml), as it is done in according to the usual clinical practice. And if&#xD;
      after two boluses of PCEA the analgesia was still ineffective a clinical bolus of 4ml of&#xD;
      lidocaína to 1 % was administered by the anesthesiologist.&#xD;
&#xD;
      In addition, in the group that was administered only PIEB, the standard infusion system was&#xD;
      compared with the high-flow infusion system.&#xD;
&#xD;
      In all patients it was evaluated and noted on the epidural record sheet the intensity of the&#xD;
      pain as the analogical visual scale (AVE), the grade of motor blockade as the modified scale&#xD;
      of Bromage and the sensitive level in different periods of time. Also registered the total&#xD;
      doses of anesthetic, the way of the childbearing finishes, the Apgar of the newborn, the&#xD;
      grade of maternal satisfaction and the side effects. Also through the software of the pump it&#xD;
      was verified if the patient had been administered rescue analgesia (PCEA or clinical&#xD;
      boluses).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2015</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>anesthetic consumption in milliliters</measure>
    <time_frame>at the end of labour</time_frame>
    <description>The anesthetic consumption in terms of analgesia of rescue of the combination of different ways of administration of anesthetic in the space epidural. The quantity of extra analgesic is already by means of boluses of PCEA or by means of clinical boluses measured in milliliters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analgesic effectiveness with AVE</measure>
    <time_frame>Baseline (just after epidural administration)</time_frame>
    <description>Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic effectiveness with AVE</measure>
    <time_frame>15 minutes after epidural administration</time_frame>
    <description>Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic effectiveness with AVE</measure>
    <time_frame>30 minutes after epidural administration</time_frame>
    <description>Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic effectiveness with AVE</measure>
    <time_frame>every 2 hours until the end of labor</time_frame>
    <description>Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade from zero to four</measure>
    <time_frame>Baseline (just after epidural administration)</time_frame>
    <description>The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):&#xD;
0 = it can raise the low extremities of the bed&#xD;
= it can bend knees and ankles&#xD;
= it can bend ankles but not the knees&#xD;
= it can bend neither ankles nor knees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade from zero to four</measure>
    <time_frame>15 minutes after epidural administration</time_frame>
    <description>The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):&#xD;
0 = it can raise the low extremities of the bed&#xD;
= it can bend knees and ankles&#xD;
= it can bend ankles but not the knees&#xD;
= it can bend neither ankles nor knees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade from zero to four</measure>
    <time_frame>30 minutes after epidural administration</time_frame>
    <description>The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):&#xD;
0 = it can raise the low extremities of the bed&#xD;
= it can bend knees and ankles&#xD;
= it can bend ankles but not the knees&#xD;
= it can bend neither ankles nor knees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor blockade from zero to four</measure>
    <time_frame>every 2 hours until the end of labor</time_frame>
    <description>The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):&#xD;
0 = it can raise the low extremities of the bed&#xD;
= it can bend knees and ankles&#xD;
= it can bend ankles but not the knees&#xD;
= it can bend neither ankles nor knees</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitive blockade from T12 to T4</measure>
    <time_frame>Baseline (just after epidural administration)</time_frame>
    <description>The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitive blockade from T12 to T4</measure>
    <time_frame>15 minutes after epidural administration</time_frame>
    <description>The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region ). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitive blockade from T12 to T4</measure>
    <time_frame>30 minutes after epidural administration</time_frame>
    <description>The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitive blockade from T12 to T4</measure>
    <time_frame>every 2 hours until the end of labor</time_frame>
    <description>The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline (just after epidural administration)</time_frame>
    <description>The patient will be evaluated and there will register the blood pressure in mm of mercury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>15 minutes after epidural administration</time_frame>
    <description>The patient will be evaluated and there will register the blood pressure in mm of mercury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>30 minutes after epidural administration</time_frame>
    <description>The patient will be evaluated and there will register the blood pressure in mm of mercury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>every 2 hours until the end of labor</time_frame>
    <description>The patient will be evaluated and there will register the blood pressure in mm of mercury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate</measure>
    <time_frame>Baseline (just after epidural administration)</time_frame>
    <description>The patient will be evaluated and there will register the maternal heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate</measure>
    <time_frame>15 minutes after epidural administration</time_frame>
    <description>The patient will be evaluated and there will register the maternal heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate</measure>
    <time_frame>30 minutes after epidural administration</time_frame>
    <description>The patient will be evaluated and there will register the maternal heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal heart rate</measure>
    <time_frame>every 2 hours until the end of labor</time_frame>
    <description>The patient will be evaluated and there will register the maternal heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal satisfaction</measure>
    <time_frame>at the end of labor</time_frame>
    <description>On having finished the childbearing, from 0 to 100 will value the grade of maternal satisfaction as an evaluation scale:&#xD;
0 = very unsatisfied with the analgesia provided by the treatment&#xD;
100 = extremely satisfied with the analgesia provided by the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>at the end of labor</time_frame>
    <description>There will be noted down also the appearance of adverse effects as the sickness and vomiting, urinal retention, pruritus and fever.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Weight in kilograms</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>The weight in kilograms will be noted on the epidural record sheet</description>
  </other_outcome>
  <other_outcome>
    <measure>Size in centimeters</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>The height in centimeters will be noted on the epidural record sheet</description>
  </other_outcome>
  <other_outcome>
    <measure>ASA from one to five</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>The ASA classification will be noted on the epidural record sheet</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational week in number</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>The Gestational week in number will be noted on the epidural record sheet</description>
  </other_outcome>
  <other_outcome>
    <measure>Cervical dilatation at the time of performing the epidural technique in centimeters</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>The dilatation in centimeters will be noted on the epidural record sheet</description>
  </other_outcome>
  <other_outcome>
    <measure>Administration of parenteral opioids and the time of administration</measure>
    <time_frame>Just before epidural administration</time_frame>
    <description>In the epidural record sheet if opioids have been administered it will be recorded as YES and if they have not been administered it will be recorded as NO. If it has been administered, the time of its admnistracion will be indicated numerically</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Labor Epidural Analgesia</condition>
  <arm_group>
    <arm_group_label>IC+PIEB+PCEA high flow</arm_group_label>
    <description>Continuous Epidural Infusion to 3ml/h more Programed Intermittent Epidural Boluses of 7ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIEB+PCEA high flow</arm_group_label>
    <description>Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PIEB+PCEA standar flow</arm_group_label>
    <description>Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of standar flow as clinical practice routine</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IC+PIEB+PCEA high flow</intervention_name>
    <description>Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.&#xD;
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.&#xD;
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.&#xD;
This intervention is included in the clinical practice routine</description>
    <arm_group_label>IC+PIEB+PCEA high flow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PIEB+PCEA high flow</intervention_name>
    <description>Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.&#xD;
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.&#xD;
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.&#xD;
In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.&#xD;
This intervention is included in the clinical practice routine</description>
    <arm_group_label>PIEB+PCEA high flow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PIEB+PCEA standar flow</intervention_name>
    <description>Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.&#xD;
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.&#xD;
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.&#xD;
In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.&#xD;
This intervention is included in the clinical practice routine</description>
    <arm_group_label>PIEB+PCEA standar flow</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be realized in women in work of labor who come our hospital and who after&#xD;
        being valued by the team of obstetrics are in favorable active period for the achievement&#xD;
        of the technique epidural previous informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women in work of established labor and contractions of moderate intensity&#xD;
&#xD;
          -  Age between 18 and 45 years&#xD;
&#xD;
          -  ASA I and II&#xD;
&#xD;
          -  Nulliparity&#xD;
&#xD;
          -  Pregnancy to term (&gt; 36semanas)&#xD;
&#xD;
          -  The only fetus of cephalic presentation&#xD;
&#xD;
          -  Cervical dilation between 2-5cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal systemic illness (Diabetes Mellitus, arterial Hypertension, Preeclampsia. . )&#xD;
&#xD;
          -  Major or equal weight to 100 Kg&#xD;
&#xD;
          -  Less height of 150cm&#xD;
&#xD;
          -  Duration of the equal or major childbearing to 24h&#xD;
&#xD;
          -  Administration of opioides parenterales in 2-4h before to performing of the epidural&#xD;
&#xD;
          -  Contraindication for neuroaxial analgesia&#xD;
&#xD;
          -  Precedents of allergy or hypersensitivity to anesthetic local&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario de La Plana</name>
      <address>
        <city>Villarreal</city>
        <state>Castellón</state>
        <zip>12540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Albright GA, Forster RM. The safety and efficacy of combined spinal and epidural analgesia/anesthesia (6,002 blocks) in a community hospital. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):117-25. doi: 10.1016/s1098-7339(99)90071-8.</citation>
    <PMID>10204896</PMID>
  </reference>
  <reference>
    <citation>Beaubien G, Drolet P, Girard M, Grenier Y. Patient-controlled epidural analgesia with fentanyl-bupivacaine: influence of prior dural puncture. Reg Anesth Pain Med. 2000 May-Jun;25(3):254-8. doi: 10.1016/s1098-7339(00)90007-5.</citation>
    <PMID>10834779</PMID>
  </reference>
  <reference>
    <citation>Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.</citation>
    <PMID>23076897</PMID>
  </reference>
  <reference>
    <citation>Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.</citation>
    <PMID>24738803</PMID>
  </reference>
  <reference>
    <citation>Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.</citation>
    <PMID>29781504</PMID>
  </reference>
  <reference>
    <citation>Birnbach DJ, Ojea LS. Combined spinal-epidural (CSE) for labor and delivery. Int Anesthesiol Clin. 2002 Fall;40(4):27-48. doi: 10.1097/00004311-200210000-00005. No abstract available.</citation>
    <PMID>12409932</PMID>
  </reference>
  <reference>
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    <PMID>10201661</PMID>
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  <reference>
    <citation>Johnson RF, Cahana A, Olenick M, Herman N, Paschall RL, Minzter B, Ramasubramanian R, Gonzalez H, Downing JW. A comparison of the placental transfer of ropivacaine versus bupivacaine. Anesth Analg. 1999 Sep;89(3):703-8. doi: 10.1097/00000539-199909000-00032.</citation>
    <PMID>10475309</PMID>
  </reference>
  <reference>
    <citation>Beilin Y, Guinn NR, Bernstein HH, Zahn J, Hossain S, Bodian CA. Local anesthetics and mode of delivery: bupivacaine versus ropivacaine versus levobupivacaine. Anesth Analg. 2007 Sep;105(3):756-63. doi: 10.1213/01.ane.0000278131.73472.f4.</citation>
    <PMID>17717236</PMID>
  </reference>
  <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>
  <reference>
    <citation>Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg. 2016 Oct;123(4):965-71. doi: 10.1213/ANE.0000000000001407.</citation>
    <PMID>27464978</PMID>
  </reference>
  <reference>
    <citation>Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.</citation>
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  <reference>
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    <PMID>28875709</PMID>
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  <reference>
    <citation>Sng BL, Zeng Y, de Souza NNA, Leong WL, Oh TT, Siddiqui FJ, Assam PN, Han NR, Chan ES, Sia AT. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. Cochrane Database Syst Rev. 2018 May 17;5(5):CD011344. doi: 10.1002/14651858.CD011344.pub2.</citation>
    <PMID>29770432</PMID>
  </reference>
  <reference>
    <citation>Klumpner TT, Lange EM, Ahmed HS, Fitzgerald PC, Wong CA, Toledo P. An in vitro evaluation of the pressure generated during programmed intermittent epidural bolus injection at varying infusion delivery speeds. J Clin Anesth. 2016 Nov;34:632-7. doi: 10.1016/j.jclinane.2016.06.017. Epub 2016 Aug 3.</citation>
    <PMID>27687462</PMID>
  </reference>
  <reference>
    <citation>Krawczyk P, Piwowar P, Salapa K, Lonc T, Andres J. Do Epidural Catheter Size and Flow Rate Affect Bolus Injection Pressure in Different Programmed Intermittent Epidural Bolus Regimens? An In Vitro Study. Anesth Analg. 2019 Dec;129(6):1587-1594. doi: 10.1213/ANE.0000000000003650.</citation>
    <PMID>31743179</PMID>
  </reference>
  <results_reference>
    <citation>Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.</citation>
    <PMID>21320088</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana</investigator_affiliation>
    <investigator_full_name>Marian Daras</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>epidural local anesthetic</keyword>
  <keyword>epidural analgesia</keyword>
  <keyword>analgesia labor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</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/NCT03839056
org study id: MAR-ROP-2015-01
nct id: NCT03839056
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators have design an observational study to know the anesthetic consumption in
      terms of rescue analgesia (Patient Controlled Epidural Analgesia (PCEA) and manual boluses)
      of the combination of different modes of administration of local anesthetic in the epidural
      space during labor analgesia offered by the new version of the CADD® infusion pump.

      Also in this pump the anesthetic can be administered across a system of standard flow
      (40-250ml/h) or of high flow (40-500ml/h), what according to studies can influence the
      diffusion epidural of the anesthetic and therefore the level of sensitive blockade.
The study is designed with healthy patients, first-time mothers, in childbearing dynamics,
      term pregnancy and nullipary. The epidural technique was performed with dose test of 3ml of
      bupivacaína 0,25 % with vasoconstrictor and a manual bolus of 0,1ml/Kg of ropivacaína 0,2%
      with fentanilo 5ug/ml.

      As soon as the informed consent about the epidural anesthesia was signed, the patient was
      informed of the possibility of taking part in the study and there is offered him the sheet of
      information of the patient. So in one group they were administered Programed Intermittent
      Epidural Boluses (PIEB) and in other group continuous Epidural Infusion (IC) plus PIEB
      according to the usual clinical practice of each anesthesiologist. In both cases the
      perfusion was of ropivacaína 0,1 % more fentanilo 2ug/ml, so that in the first group it was
      administered PIEB of 10ml every hour and in the second group a continuous infusion to 3ml/h
      plus PIEB of 7ml every hour. Also if during the period of dilatation an AVE (Analogical
      Visual Escale) greater than or equal to 4 appeared (inadequate analgesia) the patient could
      administer a 5ml PCEA bolus of the same solution (interval of closing of 20min and maximum
      dose for hour of 15ml), as it is done in according to the usual clinical practice. And if
      after two boluses of PCEA the analgesia was still ineffective a clinical bolus of 4ml of
      lidocaína to 1 % was administered by the anesthesiologist.

      In addition, in the group that was administered only PIEB, the standard infusion system was
      compared with the high-flow infusion system.

      In all patients it was evaluated and noted on the epidural record sheet the intensity of the
      pain as the analogical visual scale (AVE), the grade of motor blockade as the modified scale
      of Bromage and the sensitive level in different periods of time. Also registered the total
      doses of anesthetic, the way of the childbearing finishes, the Apgar of the newborn, the
      grade of maternal satisfaction and the side effects. Also through the software of the pump it
      was verified if the patient had been administered rescue analgesia (PCEA or clinical
      boluses).
observational model: Other
time perspective: Prospective
measure: anesthetic consumption in milliliters
time frame: at the end of labour
description: The anesthetic consumption in terms of analgesia of rescue of the combination of different ways of administration of anesthetic in the space epidural. The quantity of extra analgesic is already by means of boluses of PCEA or by means of clinical boluses measured in milliliters
measure: analgesic effectiveness with AVE
time frame: Baseline (just after epidural administration)
description: Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10
measure: analgesic effectiveness with AVE
time frame: 15 minutes after epidural administration
description: Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10
measure: analgesic effectiveness with AVE
time frame: 30 minutes after epidural administration
description: Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10
measure: analgesic effectiveness with AVE
time frame: every 2 hours until the end of labor
description: Measurement by means of the evaluation of the intensity of the pain that will be evaluated according to the analogical visual scale (AVE) with values between 0 and 10
measure: Motor blockade from zero to four
time frame: Baseline (just after epidural administration)
description: The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):
0 = it can raise the low extremities of the bed
= it can bend knees and ankles
= it can bend ankles but not the knees
= it can bend neither ankles nor knees
measure: Motor blockade from zero to four
time frame: 15 minutes after epidural administration
description: The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):
0 = it can raise the low extremities of the bed
= it can bend knees and ankles
= it can bend ankles but not the knees
= it can bend neither ankles nor knees
measure: Motor blockade from zero to four
time frame: 30 minutes after epidural administration
description: The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):
0 = it can raise the low extremities of the bed
= it can bend knees and ankles
= it can bend ankles but not the knees
= it can bend neither ankles nor knees
measure: Motor blockade from zero to four
time frame: every 2 hours until the end of labor
description: The grade of motive blockade registers according to the modified scale of Bromage (from 0 to 3):
0 = it can raise the low extremities of the bed
= it can bend knees and ankles
= it can bend ankles but not the knees
= it can bend neither ankles nor knees
measure: Sensitive blockade from T12 to T4
time frame: Baseline (just after epidural administration)
description: The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).
measure: Sensitive blockade from T12 to T4
time frame: 15 minutes after epidural administration
description: The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region ). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).
measure: Sensitive blockade from T12 to T4
time frame: 30 minutes after epidural administration
description: The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).
measure: Sensitive blockade from T12 to T4
time frame: every 2 hours until the end of labor
description: The sensory level reached will be valued according to the loss of sensibility to the cold by means of a cotton with alcohol, noting down the dermatoma where it does not exist or diminishes the sensibility (T4: nipples level, T10: level of the bellybutton, T12: groin region). For statistical analysis of this variable a numerical value was given to each dermatome so that the highest value represents a higher sensory level and therefore more dermatomes with sensitive block (T12 = 0 and T4 = 8).
measure: Blood pressure
time frame: Baseline (just after epidural administration)
description: The patient will be evaluated and there will register the blood pressure in mm of mercury
measure: Blood pressure
time frame: 15 minutes after epidural administration
description: The patient will be evaluated and there will register the blood pressure in mm of mercury
measure: Blood pressure
time frame: 30 minutes after epidural administration
description: The patient will be evaluated and there will register the blood pressure in mm of mercury
measure: Blood pressure
time frame: every 2 hours until the end of labor
description: The patient will be evaluated and there will register the blood pressure in mm of mercury
measure: Maternal heart rate
time frame: Baseline (just after epidural administration)
description: The patient will be evaluated and there will register the maternal heart rate in beats per minute
measure: Maternal heart rate
time frame: 15 minutes after epidural administration
description: The patient will be evaluated and there will register the maternal heart rate in beats per minute
measure: Maternal heart rate
time frame: 30 minutes after epidural administration
description: The patient will be evaluated and there will register the maternal heart rate in beats per minute
measure: Maternal heart rate
time frame: every 2 hours until the end of labor
description: The patient will be evaluated and there will register the maternal heart rate in beats per minute
measure: maternal satisfaction
time frame: at the end of labor
description: On having finished the childbearing, from 0 to 100 will value the grade of maternal satisfaction as an evaluation scale:
0 = very unsatisfied with the analgesia provided by the treatment
100 = extremely satisfied with the analgesia provided by the treatment
measure: adverse effects
time frame: at the end of labor
description: There will be noted down also the appearance of adverse effects as the sickness and vomiting, urinal retention, pruritus and fever.
measure: Weight in kilograms
time frame: Just before epidural administration
description: The weight in kilograms will be noted on the epidural record sheet
measure: Size in centimeters
time frame: Just before epidural administration
description: The height in centimeters will be noted on the epidural record sheet
measure: ASA from one to five
time frame: Just before epidural administration
description: The ASA classification will be noted on the epidural record sheet
measure: Gestational week in number
time frame: Just before epidural administration
description: The Gestational week in number will be noted on the epidural record sheet
measure: Cervical dilatation at the time of performing the epidural technique in centimeters
time frame: Just before epidural administration
description: The dilatation in centimeters will be noted on the epidural record sheet
measure: Administration of parenteral opioids and the time of administration
time frame: Just before epidural administration
description: In the epidural record sheet if opioids have been administered it will be recorded as YES and if they have not been administered it will be recorded as NO. If it has been administered, the time of its admnistracion will be indicated numerically
arm group label: IC+PIEB+PCEA high flow
description: Continuous Epidural Infusion to 3ml/h more Programed Intermittent Epidural Boluses of 7ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine
arm group label: PIEB+PCEA high flow
description: Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of high flow as clinical practice routine
arm group label: PIEB+PCEA standar flow
description: Programed Intermittent Epidural Boluses of 10ml every hour with PCEA of 5 ml (interval of closing of 20min and maximum dose for hour of 15ml) administered with system of infusion of standar flow as clinical practice routine
intervention type: Device
intervention name: IC+PIEB+PCEA high flow
description: Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
This intervention is included in the clinical practice routine
arm group label: IC+PIEB+PCEA high flow
intervention type: Device
intervention name: PIEB+PCEA high flow
description: Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.
This intervention is included in the clinical practice routine
arm group label: PIEB+PCEA high flow
intervention type: Device
intervention name: PIEB+PCEA standar flow
description: Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.
This intervention is included in the clinical practice routine
arm group label: PIEB+PCEA standar flow
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Spain
citation: Albright GA, Forster RM. The safety and efficacy of combined spinal and epidural analgesia/anesthesia (6,002 blocks) in a community hospital. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):117-25. doi: 10.1016/s1098-7339(99)90071-8.
PMID: 10204896
citation: Beaubien G, Drolet P, Girard M, Grenier Y. Patient-controlled epidural analgesia with fentanyl-bupivacaine: influence of prior dural puncture. Reg Anesth Pain Med. 2000 May-Jun;25(3):254-8. doi: 10.1016/s1098-7339(00)90007-5.
PMID: 10834779
citation: Simmons SW, Taghizadeh N, Dennis AT, Hughes D, Cyna AM. Combined spinal-epidural versus epidural analgesia in labour. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD003401. doi: 10.1002/14651858.CD003401.pub3.
PMID: 23076897
citation: Patel NP, El-Wahab N, Fernando R, Wilson S, Robson SC, Columb MO, Lyons GR. Fetal effects of combined spinal-epidural vs epidural labour analgesia: a prospective, randomised double-blind study. Anaesthesia. 2014 May;69(5):458-67. doi: 10.1111/anae.12602.
PMID: 24738803
citation: Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
PMID: 29781504
citation: Birnbach DJ, Ojea LS. Combined spinal-epidural (CSE) for labor and delivery. Int Anesthesiol Clin. 2002 Fall;40(4):27-48. doi: 10.1097/00004311-200210000-00005. No abstract available.
PMID: 12409932
citation: Polley LS, Columb MO, Naughton NN, Wagner DS, van de Ven CJ. Relative analgesic potencies of ropivacaine and bupivacaine for epidural analgesia in labor: implications for therapeutic indexes. Anesthesiology. 1999 Apr;90(4):944-50. doi: 10.1097/00000542-199904000-00003.
PMID: 10201661
citation: Johnson RF, Cahana A, Olenick M, Herman N, Paschall RL, Minzter B, Ramasubramanian R, Gonzalez H, Downing JW. A comparison of the placental transfer of ropivacaine versus bupivacaine. Anesth Analg. 1999 Sep;89(3):703-8. doi: 10.1097/00000539-199909000-00032.
PMID: 10475309
citation: Beilin Y, Guinn NR, Bernstein HH, Zahn J, Hossain S, Bodian CA. Local anesthetics and mode of delivery: bupivacaine versus ropivacaine versus levobupivacaine. Anesth Analg. 2007 Sep;105(3):756-63. doi: 10.1213/01.ane.0000278131.73472.f4.
PMID: 17717236
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
citation: Carvalho B, George RB, Cobb B, McKenzie C, Riley ET. Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia. Anesth Analg. 2016 Oct;123(4):965-71. doi: 10.1213/ANE.0000000000001407.
PMID: 27464978
citation: Epsztein Kanczuk M, Barrett NM, Arzola C, Downey K, Ye XY, Carvalho JC. Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor: A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Interval Time Between Boluses of a Fixed Volume of 10 mL of Bupivacaine 0.0625% With Fentanyl 2 mug/mL. Anesth Analg. 2017 Feb;124(2):537-541. doi: 10.1213/ANE.0000000000001655.
PMID: 27755057
citation: Delgado C, Ciliberto C, Bollag L, Sedensky M, Landau R. Continuous epidural infusion versus programmed intermittent epidural bolus for labor analgesia: optimal configuration of parameters to reduce physician-administered top-ups. Curr Med Res Opin. 2018 Apr;34(4):649-656. doi: 10.1080/03007995.2017.1377166. Epub 2017 Oct 6.
PMID: 28875709
citation: Sng BL, Zeng Y, de Souza NNA, Leong WL, Oh TT, Siddiqui FJ, Assam PN, Han NR, Chan ES, Sia AT. Automated mandatory bolus versus basal infusion for maintenance of epidural analgesia in labour. Cochrane Database Syst Rev. 2018 May 17;5(5):CD011344. doi: 10.1002/14651858.CD011344.pub2.
PMID: 29770432
citation: Klumpner TT, Lange EM, Ahmed HS, Fitzgerald PC, Wong CA, Toledo P. An in vitro evaluation of the pressure generated during programmed intermittent epidural bolus injection at varying infusion delivery speeds. J Clin Anesth. 2016 Nov;34:632-7. doi: 10.1016/j.jclinane.2016.06.017. Epub 2016 Aug 3.
PMID: 27687462
citation: Krawczyk P, Piwowar P, Salapa K, Lonc T, Andres J. Do Epidural Catheter Size and Flow Rate Affect Bolus Injection Pressure in Different Programmed Intermittent Epidural Bolus Regimens? An In Vitro Study. Anesth Analg. 2019 Dec;129(6):1587-1594. doi: 10.1213/ANE.0000000000003650.
PMID: 31743179
citation: Loubert C, Hinova A, Fernando R. Update on modern neuraxial analgesia in labour: a review of the literature of the last 5 years. Anaesthesia. 2011 Mar;66(3):191-212. doi: 10.1111/j.1365-2044.2010.06616.x.
PMID: 21320088
responsible party type: Sponsor-Investigator
investigator affiliation: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
investigator full name: Marian Daras
investigator title: Principal Investigator
mesh term: Agnosia
sharing ipd: No