<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/NCT02264821</url>
  </required_header>
  <id_info>
    <org_study_id>Apcisaal 01</org_study_id>
    <nct_id>NCT02264821</nct_id>
  </id_info>
  <brief_title>Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia</brief_title>
  <acronym>Apcisaal</acronym>
  <official_title>Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Madeleine Wilwerth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare effective analgesia with continuous wound infiltration of&#xD;
      ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to&#xD;
      spinal anesthesia, after elective Caesarean delivery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double blind, 3 groups&#xD;
&#xD;
        -  Control group: Rachi 0,1 ml saline, Infusion 300ml saline&#xD;
&#xD;
        -  Group rachi-morphine: 0,1ml =100µg morphine/300ml saline&#xD;
&#xD;
        -  Group KT: 0,1 ml saline/300 ml naropin 0.2%&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Effective Analgesia</measure>
    <time_frame>30 hours after spinal injection T0</time_frame>
    <description>T0 until first request of morphine PCAIV</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morphine Consumption</measure>
    <time_frame>30 hours after spinal injection T0</time_frame>
    <description>Morphine consumption with PCAIV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.</measure>
    <time_frame>30 hours after spinal injection</time_frame>
    <description>Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Post Caesarean Analgesia</condition>
  <arm_group>
    <arm_group_label>ropivacaine infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rachi morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 µg intrathecal morphine and saline infiltration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>intrathecal saline and saline infiltration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ropivacaine infiltration</intervention_name>
    <description>wound infiltration</description>
    <arm_group_label>ropivacaine infiltration</arm_group_label>
    <other_name>Naropin</other_name>
    <other_name>local anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intrathecal morphine</intervention_name>
    <description>100 µg added to the spinal anaesthesia</description>
    <arm_group_label>rachi morphine</arm_group_label>
    <other_name>spinal morphine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo in spinal anaesthesia and in wound infiltration</description>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Nacl 0,9 %, saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of&#xD;
             gestational age, admitted for a planned caesarian with a Pfannenstiel incision and&#xD;
             having signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient or contra-indication to locoregional anesthesia&#xD;
&#xD;
          -  Allergy to the products used&#xD;
&#xD;
          -  ASA 3&#xD;
&#xD;
          -  ASA 4&#xD;
&#xD;
          -  Sleep apnea syndrome and/or obesity (BMI &gt; 35)&#xD;
&#xD;
          -  Size inferior to 155cm&#xD;
&#xD;
          -  existence of a language barrier&#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>Philippe Van der Linden, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Brugmann</name>
      <address>
        <city>Bruxelles</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>April 22, 2015</results_first_submitted>
  <results_first_submitted_qc>May 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 9, 2015</results_first_posted>
  <last_update_submitted>May 21, 2015</last_update_submitted>
  <last_update_submitted_qc>May 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Madeleine Wilwerth</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>analgesia</keyword>
  <keyword>caesarean</keyword>
  <keyword>wound infiltration</keyword>
  <keyword>intrathecal morphine.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ropivacaine Infiltration</title>
          <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline&#xD;
ropivacaine infiltration: wound infiltration</description>
        </group>
        <group group_id="P2">
          <title>Rachi Morphine</title>
          <description>100 µg intrathecal morphine and saline infiltration&#xD;
intrathecal morphine: 100 µg added to the spinal anaesthesia</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>intrathecal saline and saline infiltration&#xD;
placebo: placebo in spinal anaesthesia and in wound infiltration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="64">Double Blind</participants>
                <participants group_id="P2" count="64">Double Blind</participants>
                <participants group_id="P3" count="64">Double Blind</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ropivacaine Infiltration</title>
          <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline&#xD;
ropivacaine infiltration: wound infiltration</description>
        </group>
        <group group_id="B2">
          <title>Rachi Morphine</title>
          <description>100 µg intrathecal morphine and saline infiltration&#xD;
intrathecal morphine: 100 µg added to the spinal anaesthesia</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>intrathecal saline and saline infiltration&#xD;
placebo: placebo in spinal anaesthesia and in wound infiltration</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
            <count group_id="B2" value="61"/>
            <count group_id="B3" value="58"/>
            <count group_id="B4" value="182"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" lower_limit="27" upper_limit="34"/>
                    <measurement group_id="B2" value="32" lower_limit="28" upper_limit="34"/>
                    <measurement group_id="B3" value="32" lower_limit="28" upper_limit="37"/>
                    <measurement group_id="B4" value="32" lower_limit="27" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Effective Analgesia</title>
        <description>T0 until first request of morphine PCAIV</description>
        <time_frame>30 hours after spinal injection T0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ropivacaine Infiltration</title>
            <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline&#xD;
ropivacaine infiltration: wound infiltration</description>
          </group>
          <group group_id="O2">
            <title>Rachi Morphine</title>
            <description>100 µg intrathecal morphine and saline infiltration&#xD;
intrathecal morphine: 100 µg added to the spinal anaesthesia</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>intrathecal saline and saline infiltration&#xD;
placebo: placebo in spinal anaesthesia and in wound infiltration</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Effective Analgesia</title>
          <description>T0 until first request of morphine PCAIV</description>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="351" lower_limit="227" upper_limit="594"/>
                    <measurement group_id="O2" value="380" lower_limit="215" upper_limit="1527"/>
                    <measurement group_id="O3" value="247" lower_limit="182" upper_limit="338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.</title>
        <description>Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?</description>
        <time_frame>30 hours after spinal injection</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Morphine Consumption</title>
        <description>Morphine consumption with PCAIV</description>
        <time_frame>30 hours after spinal injection T0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ropivacaine Infiltration</title>
            <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline&#xD;
ropivacaine infiltration: wound infiltration</description>
          </group>
          <group group_id="O2">
            <title>Rachi Morphine</title>
            <description>100 µg intrathecal morphine and saline infiltration&#xD;
intrathecal morphine: 100 µg added to the spinal anaesthesia</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>intrathecal saline and saline infiltration&#xD;
placebo: placebo in spinal anaesthesia and in wound infiltration</description>
          </group>
        </group_list>
        <measure>
          <title>Morphine Consumption</title>
          <description>Morphine consumption with PCAIV</description>
          <units>milligrammes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="4" upper_limit="20"/>
                    <measurement group_id="O2" value="4" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="O3" value="20.5" lower_limit="9.5" upper_limit="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Ropivacaine Infiltration</title>
          <description>ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline&#xD;
ropivacaine infiltration: wound infiltration</description>
        </group>
        <group group_id="E2">
          <title>Rachi Morphine</title>
          <description>100 µg intrathecal morphine and saline infiltration&#xD;
intrathecal morphine: 100 µg added to the spinal anaesthesia</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>intrathecal saline and saline infiltration&#xD;
placebo: placebo in spinal anaesthesia and in wound infiltration</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="58" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea and/or vomiting</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="61"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Madeleine Wilwerth</name_or_title>
      <organization>CHU Brugmann</organization>
      <phone>003224773996</phone>
      <email>madeleine.wilwerth@chu-brugmann.be</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02264821
org study id: Apcisaal 01
nct id: NCT02264821
lead sponsor: 
has dmc: No
The aim of this study is to compare effective analgesia with continuous wound infiltration of
      ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to
      spinal anesthesia, after elective Caesarean delivery.
Double blind, 3 groups

        -  Control group: Rachi 0,1 ml saline, Infusion 300ml saline

        -  Group rachi-morphine: 0,1ml =100µg morphine/300ml saline

        -  Group KT: 0,1 ml saline/300 ml naropin 0.2%
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Duration of Effective Analgesia
time frame: 30 hours after spinal injection T0
description: T0 until first request of morphine PCAIV
measure: Morphine Consumption
time frame: 30 hours after spinal injection T0
description: Morphine consumption with PCAIV
measure: Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
time frame: 30 hours after spinal injection
description: Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
arm group label: ropivacaine infiltration
arm group type: Experimental
description: ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
arm group label: rachi morphine
arm group type: Experimental
description: 100 µg intrathecal morphine and saline infiltration
arm group label: placebo
arm group type: Placebo Comparator
description: intrathecal saline and saline infiltration
intervention type: Drug
intervention name: ropivacaine infiltration
description: wound infiltration
arm group label: ropivacaine infiltration
other name: Naropin
other name: local anesthetic
intervention type: Drug
intervention name: intrathecal morphine
description: 100 µg added to the spinal anaesthesia
arm group label: rachi morphine
other name: spinal morphine
intervention type: Drug
intervention name: placebo
description: placebo in spinal anaesthesia and in wound infiltration
arm group label: placebo
other name: Nacl 0,9 %, saline solution
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Van der Linden, PhD, MD
role: Study Director
affiliation: CHU Brugmann
facility: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: Dr Madeleine Wilwerth
investigator title: Primary Investigator
mesh term: Agnosia
mesh term: Morphine
mesh term: Ropivacaine
mesh term: Anesthetics, Local
mesh term: Anesthetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 