<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/NCT04500613</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2131</org_study_id>
    <nct_id>NCT04500613</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis</brief_title>
  <official_title>Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent&#xD;
      idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels&#xD;
      and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB).&#xD;
      The ESP block is a technique that involves injecting an anesthetic medication into the&#xD;
      muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB&#xD;
      application led to a reduction in opioid use, and there is one pediatric case report of ESPB&#xD;
      use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB&#xD;
      technique is feasible and effective in the pediatric patient population.&#xD;
&#xD;
      The present study is designed to be the first randomized controlled trial to evaluate the&#xD;
      role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced&#xD;
      recovery pathway.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">February 22, 2021</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who receive bilateral, pre-incision ESPB</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Rate of adherence, number who enroll, number who receive the intervention and complete all assessments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Recruitment</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number screened/number enrolled</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blinding Assessment</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type and incidence of factors preventing performance of the block</measure>
    <time_frame>Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery</time_frame>
    <description>Patient, surgical, anesthetic, and/or work flow related barriers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of intra- and postoperative complications attributed to ESPB</measure>
    <time_frame>During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery</time_frame>
    <description>Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores at Rest and Movement</measure>
    <time_frame>PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery)</time_frame>
    <description>Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Opioid Consumption</measure>
    <time_frame>0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery)</time_frame>
    <description>Measured in mean oral morphine equivalents (OME)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first opioid use</measure>
    <time_frame>Up to 24 hours after surgery</time_frame>
    <description>Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Related Side Effects</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS) (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient/parent satisfaction with pain management</measure>
    <time_frame>At hospital discharge (average 48 hours after surgery)</time_frame>
    <description>Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Opioid Use</condition>
  <condition>Recruitment</condition>
  <arm_group>
    <arm_group_label>ESPB with Bupivacaine and Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ESPB</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone</intervention_name>
    <description>Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.</description>
    <arm_group_label>ESPB with Bupivacaine and Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)</intervention_name>
    <description>Patients who are randomized to this group will not receive a bilateral erector spinae plane block</description>
    <arm_group_label>No ESPB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 10-19 years old&#xD;
&#xD;
          -  Patients undergoing multilevel posterior spinal instrumentation and fusion&#xD;
&#xD;
          -  Undergoing surgery for correction of adolescent idiopathic scoliosis&#xD;
&#xD;
          -  Patients under the care of participating surgeons&#xD;
&#xD;
          -  English Speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 10 years old or older than 19 years old&#xD;
&#xD;
          -  Neuromuscular scoliosis&#xD;
&#xD;
          -  Patient under the care of non-participating surgeon performing the procedure&#xD;
&#xD;
          -  History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed&#xD;
             to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more&#xD;
             than 60 oral morphine equivalents (OME) daily for over 2 weeks)&#xD;
&#xD;
          -  Chronic pain conditions necessitating neuromodulating medications (gabapentin,&#xD;
             pregabalin)&#xD;
&#xD;
          -  Allergy, intolerance, or contraindication to any protocol component/study&#xD;
             medication/technique&#xD;
&#xD;
          -  Patient or parent refusal&#xD;
&#xD;
          -  Non-english speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan Ruby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery (HSS)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
    <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>Dexamethasone acetate</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.</ipd_access_criteria>
  </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/NCT04500613
org study id: 2019-2131
nct id: NCT04500613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent
      idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels
      and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB).
      The ESP block is a technique that involves injecting an anesthetic medication into the
      muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB
      application led to a reduction in opioid use, and there is one pediatric case report of ESPB
      use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB
      technique is feasible and effective in the pediatric patient population.

      The present study is designed to be the first randomized controlled trial to evaluate the
      role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced
      recovery pathway.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of patients who receive bilateral, pre-incision ESPB
time frame: through study completion, an average of 1 year
description: Rate of adherence, number who enroll, number who receive the intervention and complete all assessments
measure: Rate of Recruitment
time frame: through study completion, an average of 1 year
description: Number screened/number enrolled
measure: Blinding Assessment
time frame: 24 hours after surgery
description: Based on Bang's Blinding Index. Patients' ability to determine whether or not they received the ESPB. The success of patient blinding in each group will be quantified using the Bang Blinding Index which ranges from -1 to 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.
measure: Type and incidence of factors preventing performance of the block
time frame: Holding area, Post-Anesthesia Care Unit (PACU) (hour 0), hour 8, 12, and 24 hours after surgery
description: Patient, surgical, anesthetic, and/or work flow related barriers
measure: Attrition
time frame: through study completion, an average of 1 year
description: Number of patients who enroll but do not receive the intervention and/or study assessments, and the reasons
measure: Incidence of intra- and postoperative complications attributed to ESPB
time frame: During surgery, PACU (hour 0), hour 8, 12, and 24 hours after surgery
description: Interference with intraoperative neuromonitoring, infection, local anesthetic toxicity, bleeding/hematoma, extremity weakness
measure: Pain Scores at Rest and Movement
time frame: PACU (hour 0), hour 8, 12, and 24 hours after surgery, and at hospital discharge (average 48 hours after surgery)
description: Measured by Numeric Rating Scale (NRS) pain at rest and with movement (0 being no pain and 10 being as bad as you can imagine)
measure: Total Opioid Consumption
time frame: 0-24 hours after surgery (intraoperative, PACU, hours 8, 12, and 24 after surgery)
description: Measured in mean oral morphine equivalents (OME)
measure: Time to first opioid use
time frame: Up to 24 hours after surgery
description: Time to pressing Intravenous Patient-Controlled Analgesia (IV PCA) and to requesting first oral opioid
measure: Opioid Related Side Effects
time frame: 24 hours after surgery
description: Measured by 10 symptom Opioid Related Symptom Distress Scale (ORSDS) (symptom frequency: rarely to almost constantly; symptom severity: slight to very severe; symptom distress: not at all to very much)
measure: Patient/parent satisfaction with pain management
time frame: At hospital discharge (average 48 hours after surgery)
description: Measured via Likert rating scale (0 being strongly dissatisfied and 10 being strongly satisfied)
arm group label: ESPB with Bupivacaine and Dexamethasone
arm group type: Active Comparator
description: 12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
arm group label: No ESPB
arm group type: Placebo Comparator
description: 12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
intervention type: Procedure
intervention name: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
description: Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.
arm group label: ESPB with Bupivacaine and Dexamethasone
intervention type: Other
intervention name: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
description: Patients who are randomized to this group will not receive a bilateral erector spinae plane block
arm group label: No ESPB
criteria: 
gender: All
minimum age: 10 Years
maximum age: 19 Years
healthy volunteers: No
last name: Jordan Ruby, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Bupivacaine
mesh term: BB 1101
sharing ipd: Yes
ipd description: Individual participant data that underlie the results will be shared, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd time frame: Beginning 9 months and ending 36 months following article publication.
ipd access criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.