xml: <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/NCT05982483</url>
    </required_header>
    <id_info>
      <org_study_id>C2018-102</org_study_id>
      <nct_id>NCT05982483</nct_id>
    </id_info>
    <brief_title>Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain</brief_title>
    <official_title>Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Island Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Island Health</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>
        The goal of this clinical trial is to compare the Erector Spinae plane (ESP) block, a nerve&#xD;
        block, to usual care in emergency department patients with back pain. The main question it&#xD;
        aims to answer:&#xD;
  &#xD;
        Is the ESP block superior to usual care in the treatment of back pain in the emergency&#xD;
        department? Participants will be randomly assigned to the ESP or the usual care group. Pain&#xD;
        improvement at the time of emergency department discharge will be compared.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 8, 2019</start_date>
    <completion_date type="Actual">January 16, 2023</completion_date>
    <primary_completion_date type="Actual">January 16, 2023</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 (Care Provider, Outcomes Assessor)</masking>
      <masking_description>Participants in both cohorts had pink chlorhexidine skin prep and a dressing applied to the back. Research team members performing the telephone follow-up were blinded to treatment allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge</measure>
      <time_frame>Numeric verbal pain score (NVPS) at time of randomization compared with NVPS at time of discharge from the emergency department up to 24 hours after randomization.</time_frame>
      <description>The NVPS is an 11-point verbal pain scale from 0 to 10 with 0 representing no pain and 10 the worst pain imaginable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use</measure>
      <time_frame>Time of randomization to time of ED discharge up to 24 hours after randomization.</time_frame>
      <description>Opiate medication dose and route of administration was recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency department (ED) length of stay.</measure>
      <time_frame>Time of ED triage to time of ED discharge up to 24 hours after triage.</time_frame>
      <description>Time spent in the emergency department.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Brief Pain Inventory (BPI) score reduction from baseline</measure>
      <time_frame>Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit</time_frame>
      <description>The Brief Pain Inventory (BPI) is widely used to measure a patients' pain intensity and interference the pain has on daily function measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10with 0 representing no interference and 10 complete interference in that aspect of life. The initial BPI was recorded at time of randomization and subsequent BPI's recorded by telephone follow-up at predetermined time intervals</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients requiring post Emergency department discharge opiate analgesia use</measure>
      <time_frame>Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.</time_frame>
      <description>During telephone follow up, patients were asked if there was any opiate analgesia used during the pre-determined time period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)</measure>
      <time_frame>1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.</time_frame>
      <description>At telephone follow up at predetermined time intervals, patients were asked what their most severe level of pain they were currently experiencing as measured by the NVPS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients able to ambulate post ED treatment if unable to on ED admission</measure>
      <time_frame>Time of ED triage compared to time of ED discharge up to 24 hours after triage.</time_frame>
      <description>If patient was unable to ambulate on ED admission, did ED treatment allow ambulation without assistance: yes or no</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients requiring Emergency department (ED) return visits for back pain</measure>
      <time_frame>Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.</time_frame>
      <description>At telephone follow up at predetermined intervals, patients were asked if they had to return subsequently to the emergency department due to their back pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Back Pain</condition>
    <arm_group>
      <arm_group_label>ESP cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Randomized to receive the ultrasound-guided ESP block.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care cohort</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Randomized to usual care as dictated by the treating emergency physician</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Erector Spinae plane block using 20 ml of bupivicaine 0.25%</intervention_name>
      <description>Utilizing the in line approach, a 22 gauge 3.5&quot; spinal needle was guided the the tip of the transverse process corresponding to the area of maximal tenderness or central to the reported area of spasm. 1% lidocaine with epinephrine was used for skin anaesthesia and for hydro-localization of the needle tip on approach to the tip of the transverse process. Once the needle tip made contact with the transverse process, 2-3 ml of 1% lidocaine with epinephrine was injected to open the ESP plane. If there was no reported tachycardia after approximately 45 seconds, 20 ml of 0.25% bupivicaine was injected into the ESP plane.</description>
      <arm_group_label>ESP cohort</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Usual care</intervention_name>
      <description>Analgesia as dictated by the treating emergency physician</description>
      <arm_group_label>Usual care cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Patients deemed to have mechanical back pain with a component of&#xD;
          paravertebral tenderness or paravertebral spasm reported by the patient or noted on&#xD;
          examination by treating physician.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous recipient of erector spinae plane block&#xD;
  &#xD;
            -  exam concerning for cauda equina syndrome&#xD;
  &#xD;
            -  current IV drug use&#xD;
  &#xD;
            -  organ transplant recipient&#xD;
  &#xD;
            -  history of or suspected bleeding diathesis&#xD;
  &#xD;
            -  current use of anticoagulants&#xD;
  &#xD;
            -  sepsis or soft tissue infection at site of the block within last three months&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  overt malignancy involving skin or underlying soft tissue at the site of block&#xD;
  &#xD;
            -  allergy to any of the research medications&#xD;
  &#xD;
            -  inability to participate in telephone follow-up&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Nanaimo Regional General Hospital</name>
        <address>
          <city>Nanaimo</city>
          <state>British Columbia</state>
          <zip>V9S2B7</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Island Health</investigator_affiliation>
      <investigator_full_name>Ben Ho</investigator_full_name>
      <investigator_title>Emergency department staff physician</investigator_title>
    </responsible_party>
    <keyword>nerve block</keyword>
    <keyword>back pain</keyword>
    <keyword>regional anaesthesia</keyword>
    <keyword>analgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Back Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982483
  org study id: C2018-102
  nct id: NCT05982483
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the Erector Spinae plane (ESP) block, a nerve
        block, to usual care in emergency department patients with back pain. The main question it
        aims to answer:
  
        Is the ESP block superior to usual care in the treatment of back pain in the emergency
        department? Participants will be randomly assigned to the ESP or the usual care group. Pain
        improvement at the time of emergency department discharge will be compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: Participants in both cohorts had pink chlorhexidine skin prep and a dressing applied to the back. Research team members performing the telephone follow-up were blinded to treatment allocation.
  measure: Numeric Verbal Pain Score (NVPS) reduction at emergency department discharge
  time frame: Numeric verbal pain score (NVPS) at time of randomization compared with NVPS at time of discharge from the emergency department up to 24 hours after randomization.
  description: The NVPS is an 11-point verbal pain scale from 0 to 10 with 0 representing no pain and 10 the worst pain imaginable.
  measure: Number of patients requiring post randomization Emergency department (ED) opiate analgesia analgesia use
  time frame: Time of randomization to time of ED discharge up to 24 hours after randomization.
  description: Opiate medication dose and route of administration was recorded
  measure: Emergency department (ED) length of stay.
  time frame: Time of ED triage to time of ED discharge up to 24 hours after triage.
  description: Time spent in the emergency department.
  measure: Brief Pain Inventory (BPI) score reduction from baseline
  time frame: Time of randomization compared to 1 day, 1 week, 1 month, and 3 months post Emergency department visit
  description: The Brief Pain Inventory (BPI) is widely used to measure a patients' pain intensity and interference the pain has on daily function measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10with 0 representing no interference and 10 complete interference in that aspect of life. The initial BPI was recorded at time of randomization and subsequent BPI's recorded by telephone follow-up at predetermined time intervals
  measure: Number of patients requiring post Emergency department discharge opiate analgesia use
  time frame: Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.
  description: During telephone follow up, patients were asked if there was any opiate analgesia used during the pre-determined time period.
  measure: Post Emergency department (ED) discharge Numeric Verbal Pain Score (NVPS)
  time frame: 1 day after randomization, 1 week after randomization, 1 month after randomization, 3 months after randomization.
  description: At telephone follow up at predetermined time intervals, patients were asked what their most severe level of pain they were currently experiencing as measured by the NVPS
  measure: Number of patients able to ambulate post ED treatment if unable to on ED admission
  time frame: Time of ED triage compared to time of ED discharge up to 24 hours after triage.
  description: If patient was unable to ambulate on ED admission, did ED treatment allow ambulation without assistance: yes or no
  measure: Number of patients requiring Emergency department (ED) return visits for back pain
  time frame: Date of randomization to 1 day after randomization, 1 day after randomization to 1 week after randomization, 1week after randomization to 1 month after randomization, 1 month after randomization to 3 months after randomization.
  description: At telephone follow up at predetermined intervals, patients were asked if they had to return subsequently to the emergency department due to their back pain
  arm group label: ESP cohort
  arm group type: Experimental
  description: Randomized to receive the ultrasound-guided ESP block.
  arm group label: Usual care cohort
  arm group type: Active Comparator
  description: Randomized to usual care as dictated by the treating emergency physician
  intervention type: Procedure
  intervention name: Erector Spinae plane block using 20 ml of bupivicaine 0.25%
  description: Utilizing the in line approach, a 22 gauge 3.5" spinal needle was guided the the tip of the transverse process corresponding to the area of maximal tenderness or central to the reported area of spasm. 1% lidocaine with epinephrine was used for skin anaesthesia and for hydro-localization of the needle tip on approach to the tip of the transverse process. Once the needle tip made contact with the transverse process, 2-3 ml of 1% lidocaine with epinephrine was injected to open the ESP plane. If there was no reported tachycardia after approximately 45 seconds, 20 ml of 0.25% bupivicaine was injected into the ESP plane.
  arm group label: ESP cohort
  intervention type: Drug
  intervention name: Usual care
  description: Analgesia as dictated by the treating emergency physician
  arm group label: Usual care cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: Island Health
  investigator full name: Ben Ho
  investigator title: Emergency department staff physician
  mesh term: Back Pain
  mesh term: Bupivacaine
  sharing ipd: No