<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/NCT01674114</url>
  </required_header>
  <id_info>
    <org_study_id>2012-1</org_study_id>
    <nct_id>NCT01674114</nct_id>
  </id_info>
  <brief_title>Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration</brief_title>
  <official_title>Postoperative Morphine Consumption After Caesarean Section- TAP Block vs Intracutaneous Infiltration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean&#xD;
      section will give a measurable benefit in form of reducing Morphine consumption as compared&#xD;
      to local infiltration of the wound with local anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Caesarean section is one of the most common surgical procedures in the world and&#xD;
      postoperative pain afflicts both mother and the newborn- especially the first 48 hours after&#xD;
      birth.&#xD;
&#xD;
      Pain management at the investigators hospital is multimodal (balanced analgesia).&#xD;
      Peroperatively the wound is infiltrated with local anaesthetic performed by the obstetrician&#xD;
      at the end of the procedure. Postoperatively the patient gets routinely a combination of&#xD;
      Paracetamol and NSAID's orally and Morphine intravenously as required. The side-effects of&#xD;
      Morphine (nausea, vomiting, itching and sedation) do interfere, dose dependent, with the&#xD;
      interaction between mother and child, breastfeeding and postpartum experience.&#xD;
&#xD;
      Previous studies have compared transversus abdominis plane block (TAP block) with reduction&#xD;
      of morphine consumption in C-section (up to 50%! (1,2). So far no one has compared TAP-block&#xD;
      with local infiltration in C-section patients.&#xD;
&#xD;
      Ultrasound guided TAP-block is done by an anaesthesiologist at the end of the operation, and&#xD;
      it is viewed as a safe and easy procedure to perform. The investigators assumption is that&#xD;
      the TAP-block reduces the morphine consumption with 50% as compared to local infiltration.&#xD;
      Due to maximal dosage of Bupivacaine, it is not possible to give both types of anaesthesia at&#xD;
      the same time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>total amount of morphine consumption</measure>
    <time_frame>48 hours</time_frame>
    <description>patient controlled analgesia (PCA-pump)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to first bolus request</measure>
    <time_frame>up to 48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative morphine consumption</measure>
    <time_frame>12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative morphine consumption</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative morphine consumption</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Visual Analog Scale 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe</description>
  </secondary_outcome>
  <other_outcome>
    <measure>anti-emetics</measure>
    <time_frame>up to 48 hours</time_frame>
    <description>Antiemetics will not be given routinely, and its use will therefore also be registered</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>transversus abdominis plane block (TAP block). Ultrasound guided TAP-block at the end of surgery using 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml bilaterally by the anaesthesiologist, and 20 ml NaCl intracutaneously in the operating wound performed by the obstetrician</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound guided TAP block at the end of surgery with 20 ml NaCl bilaterally and 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml intracutaneously in the surgical wound(standard practice)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <arm_group_label>TAP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>control</intervention_name>
    <arm_group_label>control</arm_group_label>
    <other_name>intracutaneous infiltration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women that are scheduled for elective C-section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  relevant drug allergy&#xD;
&#xD;
          -  history of drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aage Telnes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <results_reference>
    <citation>Telnes A, Skogvoll E, Lonnee H. Transversus abdominis plane block vs. wound infiltration in Caesarean section: a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Apr;59(4):496-504. doi: 10.1111/aas.12498.</citation>
    <PMID>25786679</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cesarean Section</keyword>
  <keyword>Anesthetics, Local</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/NCT01674114
org study id: 2012-1
nct id: NCT01674114
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate whether a regional-block (TAP block) in Caesarean
      section will give a measurable benefit in form of reducing Morphine consumption as compared
      to local infiltration of the wound with local anesthetic.
Caesarean section is one of the most common surgical procedures in the world and
      postoperative pain afflicts both mother and the newborn- especially the first 48 hours after
      birth.

      Pain management at the investigators hospital is multimodal (balanced analgesia).
      Peroperatively the wound is infiltrated with local anaesthetic performed by the obstetrician
      at the end of the procedure. Postoperatively the patient gets routinely a combination of
      Paracetamol and NSAID's orally and Morphine intravenously as required. The side-effects of
      Morphine (nausea, vomiting, itching and sedation) do interfere, dose dependent, with the
      interaction between mother and child, breastfeeding and postpartum experience.

      Previous studies have compared transversus abdominis plane block (TAP block) with reduction
      of morphine consumption in C-section (up to 50%! (1,2). So far no one has compared TAP-block
      with local infiltration in C-section patients.

      Ultrasound guided TAP-block is done by an anaesthesiologist at the end of the operation, and
      it is viewed as a safe and easy procedure to perform. The investigators assumption is that
      the TAP-block reduces the morphine consumption with 50% as compared to local infiltration.
      Due to maximal dosage of Bupivacaine, it is not possible to give both types of anaesthesia at
      the same time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: total amount of morphine consumption
time frame: 48 hours
description: patient controlled analgesia (PCA-pump)
measure: time to first bolus request
time frame: up to 48 hours
measure: cumulative morphine consumption
time frame: 12 hours
measure: cumulative morphine consumption
time frame: 24 hours
measure: cumulative morphine consumption
time frame: 36 hours
measure: pain
time frame: up to 48 hours
description: Visual Analog Scale 0-10
measure: side effects
time frame: up to 48 hours
description: nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe
measure: anti-emetics
time frame: up to 48 hours
description: Antiemetics will not be given routinely, and its use will therefore also be registered
arm group label: TAP block
arm group type: Experimental
description: transversus abdominis plane block (TAP block). Ultrasound guided TAP-block at the end of surgery using 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml bilaterally by the anaesthesiologist, and 20 ml NaCl intracutaneously in the operating wound performed by the obstetrician
arm group label: control
arm group type: Active Comparator
description: Ultrasound guided TAP block at the end of surgery with 20 ml NaCl bilaterally and 20 ml bupivacaine 0,25% with Adrenaline 5mcg/ml intracutaneously in the surgical wound(standard practice)
intervention type: Procedure
intervention name: TAP block
arm group label: TAP block
intervention type: Procedure
intervention name: control
arm group label: control
other name: intracutaneous infiltration
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Aage Telnes, MD
role: Principal Investigator
affiliation: St. Olavs Hospital
facility: 
country: Norway
citation: Telnes A, Skogvoll E, Lonnee H. Transversus abdominis plane block vs. wound infiltration in Caesarean section: a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Apr;59(4):496-504. doi: 10.1111/aas.12498.
PMID: 25786679
responsible party type: Sponsor