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/NCT05970380</url>
    </required_header>
    <id_info>
      <org_study_id>Kyphoplasty</org_study_id>
      <nct_id>NCT05970380</nct_id>
    </id_info>
    <brief_title>Effect of Erector Spinae Plane Block in Patients Scheduled for Kyphoplasty</brief_title>
    <official_title>Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bozyaka Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bozyaka Training and Research Hospital</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>
        Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon&#xD;
        kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with&#xD;
        sedation and analgesia for the procedure. Some patients will be performed erector spinae&#xD;
        plane block with the guidance of ultrasonography for the procedure. The investigators aim to&#xD;
        evaluate the intraoperative and postoperative analgesic requirement of patients. Surgeon's&#xD;
        and patients' satisfaction will be also evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients, older than 50 years, American Society of Anesthesiologists physical status I, II,&#xD;
        III and IV and scheduled for percutaneous balloon kyphoplasty due to osteoporotic vertebra&#xD;
        fracture will be enrolled for this prospective, observational study. Written consent will be&#xD;
        taken from all patients.&#xD;
  &#xD;
        All patients will be taken to the premedication room. Standard monitorization will be&#xD;
        performed with electrocardiography, non-invasive blood pressure and pulse oximeter. A 20&#xD;
        Gauge intravenous (iv) canula will be inserted and 10-20 mg/kg iv crystalloid infusion will&#xD;
        be started. According to the neurosurgeon's preference patients will be under local&#xD;
        anesthesia with sedation and analgesia or erector spinae plane block and sedation during the&#xD;
        procedure.&#xD;
  &#xD;
        In Group Local Anesthesia (L), local anesthesia with 0.25% 20 mL bupivacaine will be given&#xD;
        extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous&#xD;
        0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered&#xD;
        to achieve sedation and analgesia.&#xD;
  &#xD;
        In Group Erector Spinae Plane Block (ESP), bilateral erector spinae plane block will be&#xD;
        performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under&#xD;
        ultrasound imaging by the anesthesiologist. 20 minutes after administration of the block, the&#xD;
        surgical procedure will be started. During the procedure intravenous 0.1 mg/kg midazolam will&#xD;
        be administered for sedation. Pain will be assessed with numeric rating scale (NRS). When NRS&#xD;
        is 4 or over 4, additional 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be given&#xD;
        intravenously.&#xD;
  &#xD;
        In the postoperative period all patients in groups, NRS will be also used to assess the pain.&#xD;
        When NRS is 4 or over 4, 1 gr paracetamol will be given intravenously. If NRS will not be&#xD;
        under 4 after 1 hour of paracetamol administration, iv 1 mg/kg tramadol will be given.&#xD;
  &#xD;
        Postoperative and intraoperative opioid consumption will be assessed to evaluate the&#xD;
        effectiveness of erector spinae plane block.&#xD;
  &#xD;
        Surgeon's and patients satisfaction will be assessed with 5 points Likert's scale; 1: very&#xD;
        dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very&#xD;
        satisfied. All outcome measures will be statistically analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Opioid consumption during surgery</measure>
      <time_frame>Within first hour of the surgical procedure</time_frame>
      <description>Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Opioid consumption after surgery</measure>
      <time_frame>Up to 24 hours after the surgical procedure</time_frame>
      <description>Opioid consumption will be assessed with the need of opioid analgesics after the surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain during surgical procedure</measure>
      <time_frame>Within the first hour of the surgical procedure</time_frame>
      <description>Pain during the surgical procedure will be assessed by using numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4 additional opioid analgesic will be given to the patient intravenously.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain after surgical procedure</measure>
      <time_frame>Up to 24 hours after the surgical procedure</time_frame>
      <description>Pain will be assessed with numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4, additional opioid analgesic will be given to the patient intravenously.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgeon's satisfaction</measure>
      <time_frame>Within 24 hours of the surgical procedure</time_frame>
      <description>The surgeon will assess the ease of the procedure and patient's comfort during the procedure with Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's satisfaction</measure>
      <time_frame>Within 24 hours of the surgical procedure</time_frame>
      <description>Patient will assess the comfort during intraoperative and postoperative period with Likert's scale 1: very dissatisfied, 2: dissatisfied, 4: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Erector Spinae Plane Block</condition>
    <arm_group>
      <arm_group_label>Local anesthesia</arm_group_label>
      <description>Local anesthesia with 0.25% 20 mL bupivacaine will be given extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous 0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered to achieve sedation and analgesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ESP Block</arm_group_label>
      <description>Bilateral erector spinae plane block will be performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under ultrasound imaging by the anesthesiologist. Intravenous 0.1 mg/kg midazolam will be administered for sedation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Erector spinae plane block</intervention_name>
      <description>Local anesthetic solution (40 mL 0.25% bupivacaine totally) will be given bilaterally between the processus transversalis of the fractured vertebra and the erector spinae muscle under ultrasound imaging by an anesthesiologist.</description>
      <arm_group_label>ESP Block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Local anesthesia</intervention_name>
      <description>Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.</description>
      <arm_group_label>Local anesthesia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with pathologic vertebra fracture that is indicated for percutaneous balloon&#xD;
          kyphoplasty will be enrolled for the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists physical status I, II, III, IV&#xD;
  &#xD;
            -  Pathologic vertebra fracture&#xD;
  &#xD;
            -  Percutaneous balloon kyphoplasty for single vertebrae&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindications for plane blocks (bleeding disorder, infection on the injection&#xD;
               side)&#xD;
  &#xD;
            -  Hemodynamic instability&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Patient's refusal&#xD;
  &#xD;
            -  Vertebra fracture due to trauma&#xD;
  &#xD;
            -  Multiple vertebra fractures&#xD;
  &#xD;
            -  Procedure under general anesthesia&#xD;
  &#xD;
            -  Allergy to local anesthetics&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Halide H Şahinkaya, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Izmir Bozyaka Training and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alper Tabanlı, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Izmir Bozyaka Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Halide H Şahinkaya, MD</last_name>
      <phone>+905058892157</phone>
      <email>drhhande@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Izmir Bozyaka Training and Research Hospital</name>
        <address>
          <city>İzmir</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Halide H Şahinkaya, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Verduzco LA. Erector spinae plane block as primary anesthetic for kyphoplasty. J Clin Anesth. 2020 May;61:109670. doi: 10.1016/j.jclinane.2019.109670. Epub 2019 Nov 26. No abstract available.</citation>
      <PMID>31784307</PMID>
    </reference>
    <reference>
      <citation>Demir U, Taskin O. Retrospective Comparison of Anesthetic Methods for Percutaneous Balloon Kyphoplasty Surgery: General Anesthesia and Erector Spinae Plane Block. Medicina (Kaunas). 2023 Jan 27;59(2):240. doi: 10.3390/medicina59020240.</citation>
      <PMID>36837442</PMID>
    </reference>
    <reference>
      <citation>Ge C, Wu X, Gao Z, Xu Z, Hao D, Dong L. Comparison of different anesthesia modalities during percutaneous kyphoplasty of osteoporotic vertebral compression fractures. Sci Rep. 2021 May 27;11(1):11102. doi: 10.1038/s41598-021-90621-9.</citation>
      <PMID>34045557</PMID>
    </reference>
    <reference>
      <citation>Wu AM, Lin ZK, Ni WF, Chi YL, Xu HZ, Wang XY, Huang QS. The existence of intravertebral cleft impact on outcomes of nonacute osteoporotic vertebral compression fractures patients treated by percutaneous kyphoplasty: a comparative study. J Spinal Disord Tech. 2014 May;27(3):E88-93. doi: 10.1097/BSD.0b013e31829142bf.</citation>
      <PMID>23563348</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bozyaka Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Halide Hande Şahinkaya</investigator_full_name>
      <investigator_title>MD, Anesthesiology Specialist, Clinical Director</investigator_title>
    </responsible_party>
    <keyword>percutaneous balloon kyphoplasty</keyword>
    <keyword>erector spinae plane block</keyword>
    <keyword>Postoperative Pain</keyword>
    <keyword>local anesthesia</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05970380
  org study id: Kyphoplasty
  nct id: NCT05970380
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon
        kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with
        sedation and analgesia for the procedure. Some patients will be performed erector spinae
        plane block with the guidance of ultrasonography for the procedure. The investigators aim to
        evaluate the intraoperative and postoperative analgesic requirement of patients. Surgeon's
        and patients' satisfaction will be also evaluated.
  Patients, older than 50 years, American Society of Anesthesiologists physical status I, II,
        III and IV and scheduled for percutaneous balloon kyphoplasty due to osteoporotic vertebra
        fracture will be enrolled for this prospective, observational study. Written consent will be
        taken from all patients.
  
        All patients will be taken to the premedication room. Standard monitorization will be
        performed with electrocardiography, non-invasive blood pressure and pulse oximeter. A 20
        Gauge intravenous (iv) canula will be inserted and 10-20 mg/kg iv crystalloid infusion will
        be started. According to the neurosurgeon's preference patients will be under local
        anesthesia with sedation and analgesia or erector spinae plane block and sedation during the
        procedure.
  
        In Group Local Anesthesia (L), local anesthesia with 0.25% 20 mL bupivacaine will be given
        extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous
        0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered
        to achieve sedation and analgesia.
  
        In Group Erector Spinae Plane Block (ESP), bilateral erector spinae plane block will be
        performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under
        ultrasound imaging by the anesthesiologist. 20 minutes after administration of the block, the
        surgical procedure will be started. During the procedure intravenous 0.1 mg/kg midazolam will
        be administered for sedation. Pain will be assessed with numeric rating scale (NRS). When NRS
        is 4 or over 4, additional 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be given
        intravenously.
  
        In the postoperative period all patients in groups, NRS will be also used to assess the pain.
        When NRS is 4 or over 4, 1 gr paracetamol will be given intravenously. If NRS will not be
        under 4 after 1 hour of paracetamol administration, iv 1 mg/kg tramadol will be given.
  
        Postoperative and intraoperative opioid consumption will be assessed to evaluate the
        effectiveness of erector spinae plane block.
  
        Surgeon's and patients satisfaction will be assessed with 5 points Likert's scale; 1: very
        dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very
        satisfied. All outcome measures will be statistically analyzed.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Opioid consumption during surgery
  time frame: Within first hour of the surgical procedure
  description: Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure.
  measure: Opioid consumption after surgery
  time frame: Up to 24 hours after the surgical procedure
  description: Opioid consumption will be assessed with the need of opioid analgesics after the surgery.
  measure: Pain during surgical procedure
  time frame: Within the first hour of the surgical procedure
  description: Pain during the surgical procedure will be assessed by using numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4 additional opioid analgesic will be given to the patient intravenously.
  measure: Pain after surgical procedure
  time frame: Up to 24 hours after the surgical procedure
  description: Pain will be assessed with numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4, additional opioid analgesic will be given to the patient intravenously.
  measure: Surgeon's satisfaction
  time frame: Within 24 hours of the surgical procedure
  description: The surgeon will assess the ease of the procedure and patient's comfort during the procedure with Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied
  measure: Patient's satisfaction
  time frame: Within 24 hours of the surgical procedure
  description: Patient will assess the comfort during intraoperative and postoperative period with Likert's scale 1: very dissatisfied, 2: dissatisfied, 4: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied
  arm group label: Local anesthesia
  description: Local anesthesia with 0.25% 20 mL bupivacaine will be given extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous 0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered to achieve sedation and analgesia.
  arm group label: ESP Block
  description: Bilateral erector spinae plane block will be performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under ultrasound imaging by the anesthesiologist. Intravenous 0.1 mg/kg midazolam will be administered for sedation.
  intervention type: Other
  intervention name: Erector spinae plane block
  description: Local anesthetic solution (40 mL 0.25% bupivacaine totally) will be given bilaterally between the processus transversalis of the fractured vertebra and the erector spinae muscle under ultrasound imaging by an anesthesiologist.
  arm group label: ESP Block
  intervention type: Other
  intervention name: Local anesthesia
  description: Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.
  arm group label: Local anesthesia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Halide H Şahinkaya, MD
  role: Study Chair
  affiliation: Izmir Bozyaka Training and Research Hospital
  last name: Alper Tabanlı, MD
  role: Study Chair
  affiliation: Izmir Bozyaka Training and Research Hospital
  last name: Halide H Şahinkaya, MD
  phone: +905058892157
  email: drhhande@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Verduzco LA. Erector spinae plane block as primary anesthetic for kyphoplasty. J Clin Anesth. 2020 May;61:109670. doi: 10.1016/j.jclinane.2019.109670. Epub 2019 Nov 26. No abstract available.
  PMID: 31784307
  citation: Demir U, Taskin O. Retrospective Comparison of Anesthetic Methods for Percutaneous Balloon Kyphoplasty Surgery: General Anesthesia and Erector Spinae Plane Block. Medicina (Kaunas). 2023 Jan 27;59(2):240. doi: 10.3390/medicina59020240.
  PMID: 36837442
  citation: Ge C, Wu X, Gao Z, Xu Z, Hao D, Dong L. Comparison of different anesthesia modalities during percutaneous kyphoplasty of osteoporotic vertebral compression fractures. Sci Rep. 2021 May 27;11(1):11102. doi: 10.1038/s41598-021-90621-9.
  PMID: 34045557
  citation: Wu AM, Lin ZK, Ni WF, Chi YL, Xu HZ, Wang XY, Huang QS. The existence of intravertebral cleft impact on outcomes of nonacute osteoporotic vertebral compression fractures patients treated by percutaneous kyphoplasty: a comparative study. J Spinal Disord Tech. 2014 May;27(3):E88-93. doi: 10.1097/BSD.0b013e31829142bf.
  PMID: 23563348
  responsible party type: Principal Investigator
  investigator affiliation: Bozyaka Training and Research Hospital
  investigator full name: Halide Hande Şahinkaya
  investigator title: MD, Anesthesiology Specialist, Clinical Director
  mesh term: Anesthetics