<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/NCT04457986</url>
  </required_header>
  <id_info>
    <org_study_id>ESP-MTIP-IVPCA</org_study_id>
    <nct_id>NCT04457986</nct_id>
  </id_info>
  <brief_title>Plane Block vs Intravenous Patient Controlled Analgesia</brief_title>
  <official_title>Randomized Controlled Comparison of the Erector Spina Plane Block and Modified Thoracolumbar Interfacial Plane Block and Intravenous Patient Controlled Analgesia in Patients Undergoing Lumbar Disc Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</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>
      Acute postoperative pain begins with surgical trauma and decreases with tissue healing.&#xD;
      Untreatable postoperative pain is one of the most important problems due to the increase in&#xD;
      respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely&#xD;
      performed, and patients often complain of postoperative pain.&#xD;
&#xD;
      Preventing and managing postoperative pain after lumber disc surgery is very important for&#xD;
      anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids,&#xD;
      preemptive analgesia methods, intravenous patient controlled analgesia methods and regional&#xD;
      anesthesia techniques are used within the multimodal analgesia strategy.&#xD;
&#xD;
      Regional anesthesia techniques are becoming increasingly widespread due to their efficiency&#xD;
      and increased applicability thanks to the use of ultrasonography. Regional anesthesia&#xD;
      techniques used in lumber disc surgery include paravertebral block, local anesthetic&#xD;
      infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar&#xD;
      interfacial plan block in recent years.&#xD;
&#xD;
      The erector spina plane block was first described in 2016, and the thoracolumbar interfacial&#xD;
      plane block in 2015, and its modification was developed in 2017. Although they vary depending&#xD;
      on the level of application, they offer analgesic activity in a wide range. Although there&#xD;
      are publications about the use of these blocks for postoperative analgesia after lumber&#xD;
      surgeries, which block is more effective has not been investigated.&#xD;
&#xD;
      This study may contribute to the development of new options for pain management after lumber&#xD;
      disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial&#xD;
      plane block, which have recently been used for postoperative pain treatment, with limited&#xD;
      research, with each other and the standard technique, intravenous patient controlled&#xD;
      analgesia, can add new applications to multimodal analgesia methods, increase patient&#xD;
      satisfaction and contribute to the early recovery process.&#xD;
&#xD;
      The objective is to compare the erector spina plane block and modified thoracolumbar&#xD;
      interfacial plane block in patients undergoing lumber disc surgery with intravenous&#xD;
      patient-controlled analgesia in terms of analgesic efficacy.&#xD;
&#xD;
      Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block&#xD;
      may decrease the postoperative pain scores, opioid consumption and time to first analgesic&#xD;
      requirement compared with intravenous patient controlled analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either&#xD;
      Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or&#xD;
      Intravenous patient controlled analgesia IV-PCA.&#xD;
&#xD;
      Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the&#xD;
      preoperative holding area.&#xD;
&#xD;
      All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated&#xD;
      with a numeric rating scale at postoperative recovery room admittance, postoperative 1st ,&#xD;
      second, 4th, 12th and 24th hours both at rest and during movement.&#xD;
&#xD;
      Postoperative tramadol consumption and time to first tramadol demand will be determined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Postoperative pain will be assessed by an anaesthesiologist unaware of group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>10 minutes after extubation</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 1st hour</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 2nd hour</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 4th hour</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 12th hour</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score</measure>
    <time_frame>postoperative 24th hour</time_frame>
    <description>Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tramadol consumption</measure>
    <time_frame>postoperative 24th hour</time_frame>
    <description>Tramadol consumption will be determined from the ambulatory infusion pump (Abott)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first analgesia request</measure>
    <time_frame>10 minutes after extubation</time_frame>
    <description>Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <arm_group>
    <arm_group_label>Erector spina plane block (ESP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified thoracolumbar interfacial plane block (MTI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous patient controlled analgesia (IV-PCA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erector spina plane block (ESP)</intervention_name>
    <description>Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol</description>
    <arm_group_label>Erector spina plane block (ESP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Modified thoracolumbar interfacial plane block (MTI)</intervention_name>
    <description>Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol</description>
    <arm_group_label>Modified thoracolumbar interfacial plane block (MTI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous patient controlled analgesia (IV-PCA)</intervention_name>
    <description>Patient will receive intravenous patient controlled analgesia with tramadol</description>
    <arm_group_label>Intravenous patient controlled analgesia (IV-PCA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective lumber discectomy or laminectomy&#xD;
&#xD;
          -  Adults&#xD;
&#xD;
          -  Aged 18-65&#xD;
&#xD;
          -  America Society of Anesthesiologists physical status I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Chronic pain condition&#xD;
&#xD;
          -  Allergic to study drugs&#xD;
&#xD;
          -  Recurrent surgical cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ÜNAL Dr YAZICIOĞLU, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
    <PMID>27501016</PMID>
  </reference>
  <reference>
    <citation>Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.</citation>
    <PMID>26149600</PMID>
  </reference>
  <results_reference>
    <citation>Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.</citation>
    <PMID>31029989</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 6, 2020</last_update_submitted>
  <last_update_submitted_qc>November 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>DILEK YAZICIOGLU</investigator_full_name>
    <investigator_title>Assoc Professor</investigator_title>
  </responsible_party>
  <keyword>postoperative pain</keyword>
  <keyword>erector spina plane block</keyword>
  <keyword>thoracolumbar interfacial plane block</keyword>
  <keyword>patient controlled analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
  </condition_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/NCT04457986
org study id: ESP-MTIP-IVPCA
nct id: NCT04457986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute postoperative pain begins with surgical trauma and decreases with tissue healing.
      Untreatable postoperative pain is one of the most important problems due to the increase in
      respiratory, cardiac and thromboembolic complications. Lumber disc surgery is widely
      performed, and patients often complain of postoperative pain.

      Preventing and managing postoperative pain after lumber disc surgery is very important for
      anesthetists. For this purpose, non-steroidal anti-inflammatory agents, intravenous opioids,
      preemptive analgesia methods, intravenous patient controlled analgesia methods and regional
      anesthesia techniques are used within the multimodal analgesia strategy.

      Regional anesthesia techniques are becoming increasingly widespread due to their efficiency
      and increased applicability thanks to the use of ultrasonography. Regional anesthesia
      techniques used in lumber disc surgery include paravertebral block, local anesthetic
      infiltration, epidural analgesia, and erector spina plan block and modified thoracolumbar
      interfacial plan block in recent years.

      The erector spina plane block was first described in 2016, and the thoracolumbar interfacial
      plane block in 2015, and its modification was developed in 2017. Although they vary depending
      on the level of application, they offer analgesic activity in a wide range. Although there
      are publications about the use of these blocks for postoperative analgesia after lumber
      surgeries, which block is more effective has not been investigated.

      This study may contribute to the development of new options for pain management after lumber
      disc surgery by comparing erector spina plane block and modified thoracolumbar interfacial
      plane block, which have recently been used for postoperative pain treatment, with limited
      research, with each other and the standard technique, intravenous patient controlled
      analgesia, can add new applications to multimodal analgesia methods, increase patient
      satisfaction and contribute to the early recovery process.

      The objective is to compare the erector spina plane block and modified thoracolumbar
      interfacial plane block in patients undergoing lumber disc surgery with intravenous
      patient-controlled analgesia in terms of analgesic efficacy.

      Hypothesis The erector spina plane block and modified thoracolumbar interfacial plane block
      may decrease the postoperative pain scores, opioid consumption and time to first analgesic
      requirement compared with intravenous patient controlled analgesia.
Patients undergoing lumber disc surgery will be randomised into 3 groups. To receive either
      Erector spina plane block (ESP) or Modified thoracolumbar interfacial plane block (MTI) or
      Intravenous patient controlled analgesia IV-PCA.

      Patients in the ESP and MTI groups will receive the blocks before anesthesia induction in the
      preoperative holding area.

      All patients will receive IV-PCA with tramadol. Postoperative analgesia will be evaluated
      with a numeric rating scale at postoperative recovery room admittance, postoperative 1st ,
      second, 4th, 12th and 24th hours both at rest and during movement.

      Postoperative tramadol consumption and time to first tramadol demand will be determined.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Postoperative pain will be assessed by an anaesthesiologist unaware of group assignment
measure: Pain score
time frame: 10 minutes after extubation
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Pain score
time frame: postoperative 1st hour
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Pain score
time frame: postoperative 2nd hour
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Pain score
time frame: postoperative 4th hour
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Pain score
time frame: postoperative 12th hour
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Pain score
time frame: postoperative 24th hour
description: Pain will be evaluated with the Numeric Rating Scale (0-10 points; 0=no pain and 10=worst pain)
measure: Tramadol consumption
time frame: postoperative 24th hour
description: Tramadol consumption will be determined from the ambulatory infusion pump (Abott)
measure: Time to first analgesia request
time frame: 10 minutes after extubation
description: Time to first tramadol request will be determined from the ambulatory infusion pump (Abott)
arm group label: Erector spina plane block (ESP)
arm group type: Experimental
description: Patients will receive Erector spina plane block (ESP) with bupivacaine for postoperative analgesia
arm group label: Modified thoracolumbar interfacial plane block (MTI)
arm group type: Experimental
description: Patients will receive Modified thoracolumbar interfacial plane block (MTI) with bupivacaine for postoperative analgesia
arm group label: Intravenous patient controlled analgesia (IV-PCA)
arm group type: Active Comparator
description: Patients will receive Intravenous patient controlled analgesia (IV-PCA) with tramadol for postoperative analgesia
intervention type: Drug
intervention name: Erector spina plane block (ESP)
description: Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
arm group label: Erector spina plane block (ESP)
intervention type: Drug
intervention name: Modified thoracolumbar interfacial plane block (MTI)
description: Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
arm group label: Modified thoracolumbar interfacial plane block (MTI)
intervention type: Drug
intervention name: Intravenous patient controlled analgesia (IV-PCA)
description: Patient will receive intravenous patient controlled analgesia with tramadol
arm group label: Intravenous patient controlled analgesia (IV-PCA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: ÜNAL Dr YAZICIOĞLU, Assoc Prof
role: Principal Investigator
affiliation: DISKAPI YILDIRIM BEYAZIT TEACHING HOSPITAL
facility: 
country: Turkey
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PMID: 27501016
citation: Hand WR, Taylor JM, Harvey NR, Epperson TI, Gunselman RJ, Bolin ED, Whiteley J. Thoracolumbar interfascial plane (TLIP) block: a pilot study in volunteers. Can J Anaesth. 2015 Nov;62(11):1196-200. doi: 10.1007/s12630-015-0431-y. Epub 2015 Jul 7.
PMID: 26149600
citation: Ueshima H, Hara E, Otake H. RETRACTED: Thoracolumbar interfascial plane block provides effective perioperative pain relief for patients undergoing lumbar spinal surgery; a prospective, randomized and double blinded trial. J Clin Anesth. 2019 Dec;58:12-17. doi: 10.1016/j.jclinane.2019.04.026. Epub 2019 Apr 25.
PMID: 31029989
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: DILEK YAZICIOGLU
investigator title: Assoc Professor
mesh term: Intervertebral Disc Displacement
sharing ipd: No