<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/NCT03825198</url>
  </required_header>
  <id_info>
    <org_study_id>B300201837508</org_study_id>
    <nct_id>NCT03825198</nct_id>
  </id_info>
  <brief_title>Lumbar Erector Spinae Plane Block for Back Surgery</brief_title>
  <acronym>LUMBES</acronym>
  <official_title>A Prospective Randomized Double Blind Trial of the Efficacy of a Bilateral Lumbar Erector Spinae Block on the 24h Morphine Consumption After Posterior Lumbar Interbody Fusion Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr M. B. Breebaart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</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>
      Title:&#xD;
&#xD;
      A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector&#xD;
      spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion&#xD;
      surgery.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objective is to study the influence of a bilateral erector spinae block on 24h&#xD;
      morphine consumption.&#xD;
&#xD;
      Endpoint:&#xD;
&#xD;
      The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are&#xD;
      intraoperative sufentanil requirement, total morphine during first 72 postoperative hours,&#xD;
      NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and&#xD;
      Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3&#xD;
&#xD;
      Number of sites Enrolling participants:&#xD;
&#xD;
      University Hospital Antwerp &amp;AZ KLINA Brasschaat&#xD;
&#xD;
      Description of study agent:&#xD;
&#xD;
      Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml&#xD;
      epinephrine Study duration Until the required study population is met Participant duration 72&#xD;
      hours&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective randomized double blind placebo controlled clinical trial we would like&#xD;
      to assess the efficacy of a bilateral lumbar erector spinae block on the 24h morphine&#xD;
      consumption after posterior lumbar interbody fusion surgery. Patients scheduled for 1-2 level&#xD;
      PLIF surgery will be recruited in AZ KLINA in Brasschaat and the University Hospital Antwerp&#xD;
      in Edegem. The study contains two arms. Subjects will be randomly allocated to an erector&#xD;
      spinae block group or the sham block group (placebo).&#xD;
&#xD;
      Stratified randomization will be done according to gender, levels of surgery and site online&#xD;
      with Q minim.The study medication will be prepared in identical premade syringes and numbered&#xD;
      according to a computer generated block randomization list (1:1 ratio ESB:sham). Subjects&#xD;
      will be assigned consecutive numbers upon inclusion to the study and receive the study&#xD;
      medication from the corresponding numbered syringes. The study medication in syringes for&#xD;
      injection will be prepared by an anesthesiologist neither involved in the study nor in the&#xD;
      care of the patient, before handing it over to the investigators. The ESB-group will receive&#xD;
      20 ml Chirocaine 0,25%. The sham block group medication will receive 20 ml Nacl0,9%. The&#xD;
      levobupivacaine and saline 0.9% are identical in appearance. All investigators, staff and&#xD;
      patients will be blinded to the treatment groups. Epinephrine is added to the placebo block&#xD;
      in order to prevent unblinding by increased heart rate or blood pressure. Unmasking will not&#xD;
      occur until statistical analysis is complete.&#xD;
&#xD;
      Patients in the erector spinae block group will receive a bilateral ESB block with an&#xD;
      injectate containing 20 ml of levobupivacaine 0.25% in each puncture. Patients allocated to&#xD;
      the sham group receive a bilateral ESB block with each injectate containing 20 mL of NaCl&#xD;
      0.9% . The blocks will be performed by experts in the field of ultrasound guided locoregional&#xD;
      anaesthesia namely dr D. van Aken, dr L. Sermeus and dr M.B. Breebaart who are also teachers&#xD;
      for the BARA (Belgian Association of Regional Anaesthesia). The blocks will be performed&#xD;
      preoperatively in a separate block room with ultrasound after placement of an iv line and&#xD;
      application of standard monitoring (ECG, NIBP, saturation). The blocks will be placed as&#xD;
      described by Chin et al. modified for lumbar level.8 First, the patient will be placed in the&#xD;
      lateral or sitting position. A curve array probe or a high frequency linear probe, depending&#xD;
      on the BMI of the patient, will be placed in a longitudinal position 2-3 cm lateral of the&#xD;
      vertebral column. The transverse processes of the vertebrae at the (mid) level of surgery,&#xD;
      the erector spinae muscle and the psoas muscle are identified. In case of two level surgery&#xD;
      the transverse process of the upper level will be considered as the preferred target.&#xD;
      Depending on the depth a 5 or 8 cm 22 G ultrasound needle (Pajunk) will be inserted with an&#xD;
      in plane technique in a cephalad to caudad direction until bone contact with the top of the&#xD;
      transverse process is reached. After slight retraction of the needle, 20 ml of the study&#xD;
      medication will be injected behind the erector spinae muscle. The same procedure will be&#xD;
      repeated on the contralateral side.&#xD;
&#xD;
      General anesthesia will then be induced in a standardized way with propofol 2-3mg/kg,&#xD;
      sufentanil 15mcg and rocuronium 0.5mg/kg. After tracheal intubation anesthesia will be&#xD;
      maintained with sevoflurane and intraoperative analgesia with sufentanil. The dosages of&#xD;
      these agents will be determined at the discretion of the anesthesiologist. At the end of&#xD;
      surgery patients will receive acetaminophen 1g IV, ketorolac (Taradyl, CSP Benelux) 0.5 mg/kg&#xD;
      (max. 30 mg) IV and a morphine loading dose (0.1 mg/kg) IV to manage postoperative pain.&#xD;
      Patients will be extubated in the operating theatre and admitted to the post anesthesia care&#xD;
      unit (PACU). Postoperative pain in the PACU and on the ward will be treated with&#xD;
      acetaminophen 1g IV round the clock (4 times daily) and by a patient controlled intravenous&#xD;
      analgesia pump (PCIA) with morphine at a concentration of 1 mg/ml and dehydrobenzperidol&#xD;
      (DHBP) 0.05 mg/ml. The PCIA will be set using a standardised protocol: no background&#xD;
      administration of morphine, a bolus dose of 1.5 mL morphine with a lock-out interval of 8&#xD;
      minutes and an hourly limit of 7.5 mg. If pain management on the PACU is inadequate (NRS &gt; 3)&#xD;
      additional boli of 1 mg morphine IV will be administered with the total additional dose of&#xD;
      morphine limited to 0.15mg/kg morphine. In case NRS is still &gt; 3 an IV ketamine (Ketalar,&#xD;
      Pfizer) bolus (0.2 mg/kg) will be given. All patients receive dexamethasone 5mg IV as&#xD;
      postoperative nausea and vomiting (PONV) prophylaxis. If needed, this will be supplemented by&#xD;
      ondansetron 4mg IV and if still insufficient with alizapride 50mg IV. Other study endpoints&#xD;
      will be retrieved from the patient data management systems&#xD;
&#xD;
      The morphine consumption during the first 24 hours postoperatively will be extracted out of&#xD;
      the PCIA pump. The total morphine dose requirement during the first 72 postoperative hours&#xD;
      will also be extracted out of the PCIA pump. Pain scores at rest will be assessed with the&#xD;
      numeric rating scale (NRS, 0=no pain 10= worst imaginable pain) and tested at regular time&#xD;
      intervals: at the time of inclusion, at the PACU (T0 = arrival at Post Anesthesia Care Unit,&#xD;
      T+15min, T+30min) and ward (twice daily- morning and evening until postoperative day 3) Pain&#xD;
      scores during defined movement (first moving to chair and upright sitting) will be examined.&#xD;
      Time to first mobilization in chair (in hours since T0) and time to first walk of twenty&#xD;
      meters (in hours since T0) will be noted in the patients study diary. The quality of recovery&#xD;
      40 score (QoR-40) will be calculated out of a series of questions patients are required to&#xD;
      answer at day 1 and 3 postoperatively. The QoR-40 is a widely used and extensively validated&#xD;
      measure of quality of recovery. It is a 40-item questionnaire on quality of recovery from&#xD;
      anesthesia, that has been shown to measure health status after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</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>
    <intervention_model_description>double blind randomised</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The medication for the sham block with NaCl or the local anaesthetic will be prepared by an independent medical caregiver who has no connection with the patient. The anaesthetics performing the block, the patient and the observation nurses/doctors collecting the data are masked. The solutions used are not distinguishable from each other.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>24 hour morphine consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative sufentanyl requirement (</measure>
    <time_frame>2-5 hours</time_frame>
    <description>total Intravenous administered sufentanyl in micrograms during surgery(10-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption 72 hours</measure>
    <time_frame>72 hours</time_frame>
    <description>total milligrams of morphine used in 72 hours after surgery (0-450), extracted out of the pca pump data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS pain scores</measure>
    <time_frame>at regular intervals and defined movement until 72 hours after surgery</time_frame>
    <description>Numeric rating scale pain score (in numbers) and rest (0= no pain10 =worst thinkable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of recovery score (QoR-40)</measure>
    <time_frame>day 1 and day 3 postoperatively</time_frame>
    <description>score in numbers of mental and psychological well being scored by list of questions (minimal score 20-maximum score 200). A high score indicates a better/faster recovery, and is inversely correlated with hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to mobilisation to chair</measure>
    <time_frame>8-72 hours</time_frame>
    <description>movements (mobilisation to chair) in hours after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to 20 meter walking</measure>
    <time_frame>8-72 hours</time_frame>
    <description>movement 20 meter walking in hours after surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>expected preoperative pain score (NRs°</measure>
    <time_frame>before surgery ( moment of inclusion)</time_frame>
    <description>Numeric rating scale pain score (in numbers). pain that people expect before they have surgery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Anaesthesia</condition>
  <condition>Surgery</condition>
  <condition>Nerve Block</condition>
  <condition>Anesthesia, Local</condition>
  <condition>Back Pain</condition>
  <condition>Spinal Fusion</condition>
  <arm_group>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.&#xD;
Postoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SHAM group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae plane block</intervention_name>
    <description>Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
    <other_name>Locoregional anaesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0,25%</intervention_name>
    <description>20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle</description>
    <arm_group_label>ESB group</arm_group_label>
    <other_name>chirocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spine fusion</intervention_name>
    <description>fusion of lumbar vertebral body on 1 or two levels</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NaCL 0,9%</intervention_name>
    <description>20 ml solution used for the infiltration between the transverse process and th erector spinal muscle</description>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil</intervention_name>
    <description>opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
    <other_name>sufenta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>induction agent for general anaesthesia ( 2-3 mg/kg)</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rocuronium Bromide</intervention_name>
    <description>muscle relaxant used during general anaesthesia ( 0,5 mg/kg)</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
    <other_name>sermon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>inhalation aesthetic used for the maintenance of general anaesthesia</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>paracetamol</intervention_name>
    <description>postoperative drug for analgesia ( 1 gram 4/day)</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>morphine pca</intervention_name>
    <description>postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
    <other_name>patient controlled analgesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>drug given during general anaesthesia to prevent postoperative nausea</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
    <other_name>aacidexam</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine</intervention_name>
    <description>loading dose morhine 0,1 mg/kg at the end of surgery</description>
    <arm_group_label>ESB group</arm_group_label>
    <arm_group_label>SHAM group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Patients scheduled for 1-2 level posterior lumbar interfusion surgery in AZ KLINA&#xD;
             Hospital or University of Antwerp Hospital (UZA) after approval of Ethical Committee&#xD;
             until all required patients are included&#xD;
&#xD;
          -  American Society of Anesthesiologist (ASA) score of 1 - 3&#xD;
&#xD;
          -  Age 18 - 75 year&#xD;
&#xD;
          -  Normal liver and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years or mentally incompetent&#xD;
&#xD;
          -  BMI &lt; 16 or BMI &gt; 35&#xD;
&#xD;
          -  Allergy to one or more substances of the study medication (= levobupivacaine,&#xD;
             dexamethasone, propofol, sufentanil, rocuronium, ketorolac, morphine, ketamine, DHBP,&#xD;
             ondansetron, alizapride)&#xD;
&#xD;
          -  Chronic strong opioid use (&gt;3 intakes per week)&#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_contact>
    <last_name>margaretha breebaart, MD PhD</last_name>
    <phone>003238213865</phone>
    <email>margaretha.breebaart@uza.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Olivier defre, MD</last_name>
    <phone>003238213042</phone>
    <email>olivier.defre@uza.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AZ KLina</name>
      <address>
        <city>Brasschaat</city>
        <state>Antwerp</state>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David van Aken, MD</last_name>
      <phone>0032-3-6505110</phone>
      <email>David.Van.Aken@klina.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Antwerp</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Margaretha Breebaart, MD, PhD</last_name>
      <phone>003238213042</phone>
      <email>margaretha.breebaart@uza.be</email>
    </contact>
    <contact_backup>
      <last_name>Olivier Defre, MD</last_name>
      <phone>003238213042</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Dr M. B. Breebaart</investigator_full_name>
    <investigator_title>senior member of staff anesthesiology department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
    <mesh_term>Rocuronium</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/NCT03825198
org study id: B300201837508
nct id: NCT03825198
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Title:

      A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector
      spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion
      surgery.

      Objectives:

      The primary objective is to study the influence of a bilateral erector spinae block on 24h
      morphine consumption.

      Endpoint:

      The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are
      intraoperative sufentanil requirement, total morphine during first 72 postoperative hours,
      NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and
      Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively

      Population:

      Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3

      Number of sites Enrolling participants:

      University Hospital Antwerp &AZ KLINA Brasschaat

      Description of study agent:

      Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml
      epinephrine Study duration Until the required study population is met Participant duration 72
      hours
In this prospective randomized double blind placebo controlled clinical trial we would like
      to assess the efficacy of a bilateral lumbar erector spinae block on the 24h morphine
      consumption after posterior lumbar interbody fusion surgery. Patients scheduled for 1-2 level
      PLIF surgery will be recruited in AZ KLINA in Brasschaat and the University Hospital Antwerp
      in Edegem. The study contains two arms. Subjects will be randomly allocated to an erector
      spinae block group or the sham block group (placebo).

      Stratified randomization will be done according to gender, levels of surgery and site online
      with Q minim.The study medication will be prepared in identical premade syringes and numbered
      according to a computer generated block randomization list (1:1 ratio ESB:sham). Subjects
      will be assigned consecutive numbers upon inclusion to the study and receive the study
      medication from the corresponding numbered syringes. The study medication in syringes for
      injection will be prepared by an anesthesiologist neither involved in the study nor in the
      care of the patient, before handing it over to the investigators. The ESB-group will receive
      20 ml Chirocaine 0,25%. The sham block group medication will receive 20 ml Nacl0,9%. The
      levobupivacaine and saline 0.9% are identical in appearance. All investigators, staff and
      patients will be blinded to the treatment groups. Epinephrine is added to the placebo block
      in order to prevent unblinding by increased heart rate or blood pressure. Unmasking will not
      occur until statistical analysis is complete.

      Patients in the erector spinae block group will receive a bilateral ESB block with an
      injectate containing 20 ml of levobupivacaine 0.25% in each puncture. Patients allocated to
      the sham group receive a bilateral ESB block with each injectate containing 20 mL of NaCl
      0.9% . The blocks will be performed by experts in the field of ultrasound guided locoregional
      anaesthesia namely dr D. van Aken, dr L. Sermeus and dr M.B. Breebaart who are also teachers
      for the BARA (Belgian Association of Regional Anaesthesia). The blocks will be performed
      preoperatively in a separate block room with ultrasound after placement of an iv line and
      application of standard monitoring (ECG, NIBP, saturation). The blocks will be placed as
      described by Chin et al. modified for lumbar level.8 First, the patient will be placed in the
      lateral or sitting position. A curve array probe or a high frequency linear probe, depending
      on the BMI of the patient, will be placed in a longitudinal position 2-3 cm lateral of the
      vertebral column. The transverse processes of the vertebrae at the (mid) level of surgery,
      the erector spinae muscle and the psoas muscle are identified. In case of two level surgery
      the transverse process of the upper level will be considered as the preferred target.
      Depending on the depth a 5 or 8 cm 22 G ultrasound needle (Pajunk) will be inserted with an
      in plane technique in a cephalad to caudad direction until bone contact with the top of the
      transverse process is reached. After slight retraction of the needle, 20 ml of the study
      medication will be injected behind the erector spinae muscle. The same procedure will be
      repeated on the contralateral side.

      General anesthesia will then be induced in a standardized way with propofol 2-3mg/kg,
      sufentanil 15mcg and rocuronium 0.5mg/kg. After tracheal intubation anesthesia will be
      maintained with sevoflurane and intraoperative analgesia with sufentanil. The dosages of
      these agents will be determined at the discretion of the anesthesiologist. At the end of
      surgery patients will receive acetaminophen 1g IV, ketorolac (Taradyl, CSP Benelux) 0.5 mg/kg
      (max. 30 mg) IV and a morphine loading dose (0.1 mg/kg) IV to manage postoperative pain.
      Patients will be extubated in the operating theatre and admitted to the post anesthesia care
      unit (PACU). Postoperative pain in the PACU and on the ward will be treated with
      acetaminophen 1g IV round the clock (4 times daily) and by a patient controlled intravenous
      analgesia pump (PCIA) with morphine at a concentration of 1 mg/ml and dehydrobenzperidol
      (DHBP) 0.05 mg/ml. The PCIA will be set using a standardised protocol: no background
      administration of morphine, a bolus dose of 1.5 mL morphine with a lock-out interval of 8
      minutes and an hourly limit of 7.5 mg. If pain management on the PACU is inadequate (NRS > 3)
      additional boli of 1 mg morphine IV will be administered with the total additional dose of
      morphine limited to 0.15mg/kg morphine. In case NRS is still > 3 an IV ketamine (Ketalar,
      Pfizer) bolus (0.2 mg/kg) will be given. All patients receive dexamethasone 5mg IV as
      postoperative nausea and vomiting (PONV) prophylaxis. If needed, this will be supplemented by
      ondansetron 4mg IV and if still insufficient with alizapride 50mg IV. Other study endpoints
      will be retrieved from the patient data management systems

      The morphine consumption during the first 24 hours postoperatively will be extracted out of
      the PCIA pump. The total morphine dose requirement during the first 72 postoperative hours
      will also be extracted out of the PCIA pump. Pain scores at rest will be assessed with the
      numeric rating scale (NRS, 0=no pain 10= worst imaginable pain) and tested at regular time
      intervals: at the time of inclusion, at the PACU (T0 = arrival at Post Anesthesia Care Unit,
      T+15min, T+30min) and ward (twice daily- morning and evening until postoperative day 3) Pain
      scores during defined movement (first moving to chair and upright sitting) will be examined.
      Time to first mobilization in chair (in hours since T0) and time to first walk of twenty
      meters (in hours since T0) will be noted in the patients study diary. The quality of recovery
      40 score (QoR-40) will be calculated out of a series of questions patients are required to
      answer at day 1 and 3 postoperatively. The QoR-40 is a widely used and extensively validated
      measure of quality of recovery. It is a 40-item questionnaire on quality of recovery from
      anesthesia, that has been shown to measure health status after surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blind randomised
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The medication for the sham block with NaCl or the local anaesthetic will be prepared by an independent medical caregiver who has no connection with the patient. The anaesthetics performing the block, the patient and the observation nurses/doctors collecting the data are masked. The solutions used are not distinguishable from each other.
measure: 24 hour morphine consumption
time frame: 24 hours
description: total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.
measure: Intraoperative sufentanyl requirement (
time frame: 2-5 hours
description: total Intravenous administered sufentanyl in micrograms during surgery(10-100)
measure: Morphine consumption 72 hours
time frame: 72 hours
description: total milligrams of morphine used in 72 hours after surgery (0-450), extracted out of the pca pump data
measure: NRS pain scores
time frame: at regular intervals and defined movement until 72 hours after surgery
description: Numeric rating scale pain score (in numbers) and rest (0= no pain10 =worst thinkable pain)
measure: Quality of recovery score (QoR-40)
time frame: day 1 and day 3 postoperatively
description: score in numbers of mental and psychological well being scored by list of questions (minimal score 20-maximum score 200). A high score indicates a better/faster recovery, and is inversely correlated with hospital stay
measure: time to mobilisation to chair
time frame: 8-72 hours
description: movements (mobilisation to chair) in hours after surgery
measure: time to 20 meter walking
time frame: 8-72 hours
description: movement 20 meter walking in hours after surgery
measure: expected preoperative pain score (NRs°
time frame: before surgery ( moment of inclusion)
description: Numeric rating scale pain score (in numbers). pain that people expect before they have surgery.
arm group label: ESB group
arm group type: Active Comparator
description: Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.
Postoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.
arm group label: SHAM group
arm group type: Sham Comparator
description: Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.
intervention type: Procedure
intervention name: Erector spinae plane block
description: Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle
arm group label: ESB group
arm group label: SHAM group
other name: Locoregional anaesthesia
intervention type: Drug
intervention name: Levobupivacaine 0,25%
description: 20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle
arm group label: ESB group
other name: chirocaine
intervention type: Procedure
intervention name: spine fusion
description: fusion of lumbar vertebral body on 1 or two levels
arm group label: ESB group
arm group label: SHAM group
intervention type: Drug
intervention name: NaCL 0,9%
description: 20 ml solution used for the infiltration between the transverse process and th erector spinal muscle
arm group label: SHAM group
intervention type: Drug
intervention name: Sufentanil
description: opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)
arm group label: ESB group
arm group label: SHAM group
other name: sufenta
intervention type: Drug
intervention name: propofol
description: induction agent for general anaesthesia ( 2-3 mg/kg)
arm group label: ESB group
arm group label: SHAM group
intervention type: Drug
intervention name: Rocuronium Bromide
description: muscle relaxant used during general anaesthesia ( 0,5 mg/kg)
arm group label: ESB group
arm group label: SHAM group
other name: sermon
intervention type: Drug
intervention name: sevoflurane
description: inhalation aesthetic used for the maintenance of general anaesthesia
arm group label: ESB group
arm group label: SHAM group
intervention type: Drug
intervention name: paracetamol
description: postoperative drug for analgesia ( 1 gram 4/day)
arm group label: ESB group
arm group label: SHAM group
intervention type: Drug
intervention name: Ketorolac
description: non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)
arm group label: ESB group
arm group label: SHAM group
intervention type: Drug
intervention name: morphine pca
description: postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml
arm group label: ESB group
arm group label: SHAM group
other name: patient controlled analgesia
intervention type: Drug
intervention name: Dexamethasone
description: drug given during general anaesthesia to prevent postoperative nausea
arm group label: ESB group
arm group label: SHAM group
other name: aacidexam
intervention type: Drug
intervention name: Morphine
description: loading dose morhine 0,1 mg/kg at the end of surgery
arm group label: ESB group
arm group label: SHAM group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: margaretha breebaart, MD PhD
phone: 003238213865
email: margaretha.breebaart@uza.be
last name: Olivier defre, MD
phone: 003238213042
email: olivier.defre@uza.be
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Dr M. B. Breebaart
investigator title: senior member of staff anesthesiology department
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Ketorolac
mesh term: Sufentanil
mesh term: Morphine
mesh term: Bromides
mesh term: Propofol
mesh term: Sevoflurane
mesh term: Levobupivacaine
mesh term: Rocuronium
sharing ipd: No