<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/NCT02223533</url>
  </required_header>
  <id_info>
    <org_study_id>sork-2011111058</org_study_id>
    <nct_id>NCT02223533</nct_id>
  </id_info>
  <brief_title>Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial</brief_title>
  <official_title>Multimodal Analgesia With Interfascial Continuous Wound Infiltration of a Local Anaesthetic vs Intravenous Opioids After Laparoscopic Colon Surgery: A Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Galdakao-Usansolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Galdakao-Usansolo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan&#xD;
      can help control postoperative pain. Placing a wound catheter intraoperatively following&#xD;
      colon surgery could optimize the control of acute pain with less consumption of opioids and&#xD;
      few adverse effects.&#xD;
&#xD;
      Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo&#xD;
      laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.&#xD;
&#xD;
      Patients were recruited and randomly allocated to wound catheter placement plus standard&#xD;
      postoperative analgesia or standard postoperative analgesia alone. A physician from the acute&#xD;
      pain management unit monitored all patients for at multiple points over the first 48 hours&#xD;
      after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and&#xD;
      amount of intravenous morphine used via patient controlled infusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration</measure>
    <time_frame>Over the 48 hours after laparoscopic colon surgery</time_frame>
    <description>Numerical Rating Pain Scale was used to measure the after-intervention Pain. This scale is widely used and shows good correlation with the Visual Analogue scale, specifically in the case of elderly individuals. Compared to other scales, it has low error rates and high validity. This score was assessed in all the participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of intravenous morphine consumption after laparoscopic colon surgery</measure>
    <time_frame>Over the 48 hours after laparoscopic colon surgery</time_frame>
    <description>Intravenous morphine consumption was administrated via patient-controlled analgesia device. The consumption was evaluated in all participants in the study at the following measurement points: at 30 min, 2h, 8h, 24h, and 48h after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications related to intravenous morphine consumption</measure>
    <time_frame>Over the 48 hours after laparoscopic colon surgery</time_frame>
    <description>Complications related to intravenous morphine consumption were measured: nausea, vomiting and pruritus throughout the treatment period. Paralytic ileus awas measured 24h after surgery. This was assessed for all patients. Moreover, especially for patients belonging to the experimental group, potential adverse effects from placement of the wound catheter such as infection or haematoma at the surgical site or potential toxicity of local anesthetic (e.g., tinnitus, obnubilation) were recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Wound catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>analgesia with wound catheter after colon surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>morphine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>analgesia with morphine after colon surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>19Gx500-mm Pajunk InfiltraLong® catheter</intervention_name>
    <description>Before completing the surgery, the surgical team inserted a 19Gx500-mm Pajunk InfiltraLong® catheter with multiple perforations in the last few centimeters before the tip to allow for local anesthetic administration.</description>
    <arm_group_label>Wound catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>morphine</intervention_name>
    <description>After the intervention patients had access to intravenous morphine via a patient-controlled analgesia</description>
    <arm_group_label>morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients were eligible for the study if they were aged 18 years or older, with an&#xD;
             American Society of Anesthesiologists (ASA) 14 grade of I to IV (anaesthetic risk),&#xD;
             were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to&#xD;
             participate by signing an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients were excluded if they were allergic to amides or pyrazolones, were likely to&#xD;
             require conversion to open surgery with laparotomy, were long-term users of opioids,&#xD;
             required emergency surgery, were unable to participate due to cognitive deterioration,&#xD;
             or declined to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sorkunde Telletxea, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Galdakao-Usansolo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de GAldakao-Usansolo</name>
      <address>
        <city>Usansolo</city>
        <state>Biscay</state>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 21, 2014</last_update_submitted>
  <last_update_submitted_qc>August 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Galdakao-Usansolo</investigator_affiliation>
    <investigator_full_name>Sorkunde Telletxea, MD, PhD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>analgesia</keyword>
  <keyword>post-operative</keyword>
  <keyword>wound catheter infusion</keyword>
  <keyword>laparoscopic colon surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02223533
org study id: sork-2011111058
nct id: NCT02223533
lead sponsor: 
has dmc: No
Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan
      can help control postoperative pain. Placing a wound catheter intraoperatively following
      colon surgery could optimize the control of acute pain with less consumption of opioids and
      few adverse effects.

      Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo
      laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.

      Patients were recruited and randomly allocated to wound catheter placement plus standard
      postoperative analgesia or standard postoperative analgesia alone. A physician from the acute
      pain management unit monitored all patients for at multiple points over the first 48 hours
      after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and
      amount of intravenous morphine used via patient controlled infusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Assessment of Numerical Rating Pain Scale (NRS) after laparoscopic colon surgery using interfascial continuous wound infiltration
time frame: Over the 48 hours after laparoscopic colon surgery
description: Numerical Rating Pain Scale was used to measure the after-intervention Pain. This scale is widely used and shows good correlation with the Visual Analogue scale, specifically in the case of elderly individuals. Compared to other scales, it has low error rates and high validity. This score was assessed in all the participants.
measure: Assessment of intravenous morphine consumption after laparoscopic colon surgery
time frame: Over the 48 hours after laparoscopic colon surgery
description: Intravenous morphine consumption was administrated via patient-controlled analgesia device. The consumption was evaluated in all participants in the study at the following measurement points: at 30 min, 2h, 8h, 24h, and 48h after the intervention.
measure: Complications related to intravenous morphine consumption
time frame: Over the 48 hours after laparoscopic colon surgery
description: Complications related to intravenous morphine consumption were measured: nausea, vomiting and pruritus throughout the treatment period. Paralytic ileus awas measured 24h after surgery. This was assessed for all patients. Moreover, especially for patients belonging to the experimental group, potential adverse effects from placement of the wound catheter such as infection or haematoma at the surgical site or potential toxicity of local anesthetic (e.g., tinnitus, obnubilation) were recorded.
arm group label: Wound catheter
arm group type: Experimental
description: analgesia with wound catheter after colon surgery
arm group label: morphine
arm group type: Active Comparator
description: analgesia with morphine after colon surgery
intervention type: Device
intervention name: 19Gx500-mm Pajunk InfiltraLong® catheter
description: Before completing the surgery, the surgical team inserted a 19Gx500-mm Pajunk InfiltraLong® catheter with multiple perforations in the last few centimeters before the tip to allow for local anesthetic administration.
arm group label: Wound catheter
intervention type: Drug
intervention name: morphine
description: After the intervention patients had access to intravenous morphine via a patient-controlled analgesia
arm group label: morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sorkunde Telletxea, MD, PhD
role: Principal Investigator
affiliation: Hospital Galdakao-Usansolo
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Galdakao-Usansolo
investigator full name: Sorkunde Telletxea, MD, PhD
investigator title: MD, PhD
mesh term: Morphine