<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/NCT04403360</url>
  </required_header>
  <id_info>
    <org_study_id>B707201837276</org_study_id>
    <nct_id>NCT04403360</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery</brief_title>
  <official_title>Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Saint Pierre Ottignies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Saint Pierre Ottignies</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Lumbar spinae stenosis surgery is a frequent intervention resulting in important&#xD;
      postoperative pain. Management of this postoperative pain is thus important. Different pain&#xD;
      management therapies exist. The erector spinae plane (ESP) block was described in 2016. It&#xD;
      involves the injection of local anesthetics into the interfascial plane, deep to erector&#xD;
      spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal&#xD;
      nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and&#xD;
      thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of&#xD;
      surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total 24 h Piritramide consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Total consumption of Piritramide consumption after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quebec back pain disability scale (QBPDS)</measure>
    <time_frame>At 2 months]</time_frame>
    <description>A questionnaire developed to measure the level of functional disability for patients with low back pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <condition>Erector Spinae Plane Block</condition>
  <arm_group>
    <arm_group_label>Erector Spinae plane Block (ESPB) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local anesthesia infiltration by the surgeon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ESPB</intervention_name>
    <description>Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery</description>
    <arm_group_label>Erector Spinae plane Block (ESPB) group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Local infiltration by the surgeon</intervention_name>
    <description>Local infiltration of anesthetics at surgical site after skin incision</description>
    <arm_group_label>Local anesthesia infiltration by the surgeon</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Any lumbar spinae surgery on 2 or more lumbar levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to NSAID&#xD;
&#xD;
          -  Allergy to any local anesthetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georges SAMOURI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Saint Pierre Ottignies</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Georges SAMOURI, MD</last_name>
    <phone>003210437260</phone>
    <email>georges.samouri@cspo.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicolas PARISI, MD</last_name>
    <phone>003210437608</phone>
    <email>nicolas.parisi@cspo.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Clinique Saint Pierre</name>
      <address>
        <city>Ottignies</city>
        <state>Brabant Wallon</state>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Georges SAMOURI, MD</last_name>
      <phone>003210437260</phone>
      <email>georges.samouri@cspo.be</email>
    </contact>
    <contact_backup>
      <last_name>Nicolas PARISI, MD</last_name>
      <phone>003210437608</phone>
      <email>nicolas.parisi@cspo.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
    <PMID>27501016</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinique Saint Pierre Ottignies</investigator_affiliation>
    <investigator_full_name>Georges Samouri</investigator_full_name>
    <investigator_title>Georges Samouri M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data will be presented in future manuscripts.</ipd_description>
  </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/NCT04403360
org study id: B707201837276
nct id: NCT04403360
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lumbar spinae stenosis surgery is a frequent intervention resulting in important
      postoperative pain. Management of this postoperative pain is thus important. Different pain
      management therapies exist. The erector spinae plane (ESP) block was described in 2016. It
      involves the injection of local anesthetics into the interfascial plane, deep to erector
      spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal
      nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and
      thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of
      surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Total 24 h Piritramide consumption
time frame: 24 hours
description: Total consumption of Piritramide consumption after surgery
measure: Quebec back pain disability scale (QBPDS)
time frame: At 2 months]
description: A questionnaire developed to measure the level of functional disability for patients with low back pain
arm group label: Erector Spinae plane Block (ESPB) group
arm group type: Experimental
description: The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery.
arm group label: Local anesthesia infiltration by the surgeon
arm group type: Active Comparator
description: The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)
intervention type: Procedure
intervention name: ESPB
description: Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
arm group label: Erector Spinae plane Block (ESPB) group
intervention type: Procedure
intervention name: Local infiltration by the surgeon
description: Local infiltration of anesthetics at surgical site after skin incision
arm group label: Local anesthesia infiltration by the surgeon
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Georges SAMOURI, MD
role: Principal Investigator
affiliation: Clinique Saint Pierre Ottignies
last name: Georges SAMOURI, MD
phone: 003210437260
email: georges.samouri@cspo.be
last name: Nicolas PARISI, MD
phone: 003210437608
email: nicolas.parisi@cspo.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PMID: 27501016
responsible party type: Principal Investigator
investigator affiliation: Clinique Saint Pierre Ottignies
investigator full name: Georges Samouri
investigator title: Georges Samouri M.D.
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No
ipd description: All data will be presented in future manuscripts.