<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/NCT04473508</url>
  </required_header>
  <id_info>
    <org_study_id>LOCAL/2018/PC-02</org_study_id>
    <nct_id>NCT04473508</nct_id>
  </id_info>
  <brief_title>Erectus Nerve Block for Lumbar Spine Surgery</brief_title>
  <acronym>EFABE</acronym>
  <official_title>Erectus Nerve Block for Lumbar Spine Surgery : a Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nīmes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nīmes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      : Spine surgery induced severe postoperative pain. Several techniques as intravenous&#xD;
      multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the&#xD;
      first postoperative days. Regional anesthesia using the erectus nerve block is a simple&#xD;
      infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve&#xD;
      block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve&#xD;
      block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine&#xD;
      surgery. The investigators hypothesized that eructor nerve block induced a large block from&#xD;
      L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2019</start_date>
  <completion_date type="Actual">September 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>morphine consumption (mg)</measure>
    <time_frame>24 Hours after surgery</time_frame>
    <description>Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>from surgery to 3 months</time_frame>
    <description>Nausea, vomiting, confusion, urinary retention, hematoma, reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain at rest and at movement: Visual Analogic scale</measure>
    <time_frame>Day 1 to Day 3, Day od hospital discharge and month 3</time_frame>
    <description>Visual Analogic scale of pain (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>chronic pain: DN4 questionnaire</measure>
    <time_frame>Questionnaire DN4 at 3 months</time_frame>
    <description>pain score as mesured with DN4 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>hospital length of stay, an average of 4 days</time_frame>
    <description>Number of day in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the post-intervention care unit</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of minutes that patient stay in post intervention care unit in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction: visual analogic scale</measure>
    <time_frame>Day of hospital discharge, an average of day 4</time_frame>
    <description>Patient satisfaction mesured with a visual analogic scale (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Quality of life: EQ-5D Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Quality of life mesured with EQ-5D Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Spine Surgery</condition>
  <condition>Pain Relief</condition>
  <condition>Morphine</condition>
  <condition>AdverseEvent</condition>
  <arm_group>
    <arm_group_label>Treated</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Local administration of Placebo ( Saline Solution)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local administration of ropivacaine</intervention_name>
    <description>Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery</description>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Local administration of placebo (saline solution)</intervention_name>
    <description>injection of saline solution in addition with conventional anesthesia for spine surgery</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt; 18years and &lt;80 years&#xD;
&#xD;
          -  lumbar spine surgery (2-4 levels)&#xD;
&#xD;
          -  posterior approach&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal&#xD;
&#xD;
          -  age &lt; 18yrs&#xD;
&#xD;
          -  &lt;50 kg and &gt;120 kg&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  renal or hepatic severe desease&#xD;
&#xD;
          -  ASA 4&#xD;
&#xD;
          -  no French speaking&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  local or systemic infection&#xD;
&#xD;
          -  surgical resumption of the surgical site&#xD;
&#xD;
          -  surgery involving a thoracic approach&#xD;
&#xD;
          -  allergy to local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geoffrey Avis, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geoffrey.avis@chu-nimes.fr</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Nimes</name>
      <address>
        <city>Nîmes</city>
        <state>Gard</state>
        <zip>30 000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_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/NCT04473508
org study id: LOCAL/2018/PC-02
nct id: NCT04473508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
: Spine surgery induced severe postoperative pain. Several techniques as intravenous
      multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the
      first postoperative days. Regional anesthesia using the erectus nerve block is a simple
      infiltration across lamina of the vertebra: Ultrasound-guided posterior ramus of spinal nerve
      block for anesthesia and analgesia in lumbar spinal surgery This study compared erector nerve
      block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine
      surgery. The investigators hypothesized that eructor nerve block induced a large block from
      L1 to L5 that induced posterior nerve roots block anesthesia. This block reduced pain after
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: morphine consumption (mg)
time frame: 24 Hours after surgery
description: Quantity administered in the post-interventional monitoring room and in hospitalization via a self-controlled morphine pump by the patient
measure: Adverse events
time frame: from surgery to 3 months
description: Nausea, vomiting, confusion, urinary retention, hematoma, reintervention
measure: pain at rest and at movement: Visual Analogic scale
time frame: Day 1 to Day 3, Day od hospital discharge and month 3
description: Visual Analogic scale of pain (0-10)
measure: chronic pain: DN4 questionnaire
time frame: Questionnaire DN4 at 3 months
description: pain score as mesured with DN4 questionnaire
measure: Length of hospital stay
time frame: hospital length of stay, an average of 4 days
description: Number of day in hospital
measure: Length of stay in the post-intervention care unit
time frame: Day 1
description: Number of minutes that patient stay in post intervention care unit in minutes
measure: Patient Satisfaction: visual analogic scale
time frame: Day of hospital discharge, an average of day 4
description: Patient satisfaction mesured with a visual analogic scale (0-10)
measure: Patient Quality of life: EQ-5D Questionnaire
time frame: 3 months
description: Patient Quality of life mesured with EQ-5D Questionnaire
arm group label: Treated
arm group type: Experimental
description: active treatment (Local anaesthetic): Local administration of ropivacaine 30 mL (5mg/mL)
arm group label: Control
arm group type: Placebo Comparator
description: Local administration of Placebo ( Saline Solution)
intervention type: Drug
intervention name: Local administration of ropivacaine
description: Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
arm group label: Treated
intervention type: Drug
intervention name: Local administration of placebo (saline solution)
description: injection of saline solution in addition with conventional anesthesia for spine surgery
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Geoffrey Avis, Md
role: Principal Investigator
affiliation: Geoffrey.avis@chu-nimes.fr
facility: 
country: France
responsible party type: Sponsor
mesh term: Ropivacaine
sharing ipd: No