<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/NCT04459923</url>
  </required_header>
  <id_info>
    <org_study_id>B.30.2.ATA.0.01.00/290</org_study_id>
    <nct_id>NCT04459923</nct_id>
  </id_info>
  <brief_title>Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery</brief_title>
  <acronym>EsPITHX</acronym>
  <official_title>The Effects of the Epidural Catheter and Ultrason-guided Erector Spina Plan Block Catheter on Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk University</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>
      Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery&#xD;
      (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary,&#xD;
      mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy&#xD;
      can be performed with smaller incisions using video support. While being less invasive in&#xD;
      comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve&#xD;
      and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain&#xD;
      can be more intense than expected after thoracoscopic procedures. Post-operation pain is not&#xD;
      just an acute problem; 20% of the patients develop chronic incision pain after a thoracic&#xD;
      surgery.&#xD;
&#xD;
      particiants hypothesis is that continue ESP block catheter application is non-inferior than&#xD;
      epidural catheter application in the first post-operative 48 hours regarding post-operative&#xD;
      pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on&#xD;
      post-operative pain in patients undergoing VATS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery&#xD;
      (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary,&#xD;
      mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy&#xD;
      can be performed with smaller incisions using video support. Literature shows that resections&#xD;
      performed with VATS result in shorter hospital stay, lower complication rates, lower&#xD;
      mortality rates and similar survivability rates in comparison to thoracotomy. While being&#xD;
      less invasive in comparison to open surgery options, thoracoscopic surgery may damage the&#xD;
      intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision&#xD;
      area. Therefore, pain can be more intense than expected after thoracoscopic procedures.&#xD;
      Post-operation pain is not just an acute problem; 20% of the patients develop chronic&#xD;
      incision pain after a thoracic surgery.&#xD;
&#xD;
      Post-operative pain is a type of acute pain which starts with surgical procedure and ends&#xD;
      with tissue recovery. Eliminating this pain is one of the important purposes of anaesthesia.&#xD;
      Post-operative analgesia methods may prevent the patient from feeling pain, but there has&#xD;
      been no consensus regarding pain management, and generally a multi-modal approach is the most&#xD;
      preferable approach. While various methods are used for post-operation analgesia, studies to&#xD;
      increase patient satisfaction are still ongoing.&#xD;
&#xD;
      Thoracic epidural analgesia (TEA) and paravertebral block are gold standard of analgesia&#xD;
      methods for thoracoscopy operations, and these are widely used for VATS procedures. An&#xD;
      epidural application generally performed at the level of T5-7 intervertebral space for&#xD;
      thoracic surgery. While intra-operative analgesia is also provided using by an epidural&#xD;
      catheter, it is also the first preference in post-operative analgesia management. It can be&#xD;
      applied by continuous infusion of local anesthetic, or bolus dosages with 4-6 hours&#xD;
      intervals.&#xD;
&#xD;
      Erector spina plane block (ESPB) is a type of block applied by injection of a local&#xD;
      anaesthetic into the interfacial plane under the erector spina muscle, and it is defined as&#xD;
      an analgesic method for thoracic neuropathic pain in 2016. The dermatome area it covers&#xD;
      varies according to the level of application. It can be applied under USG guidance and its&#xD;
      application may be considered less invasive in comparison to thoracic epidural. Due to its&#xD;
      easier application it can prove to be a more popular approach in the future. In thoracic&#xD;
      surgeries, single-shut at the T5-6 level can be used or multiple shuts at multiple levels can&#xD;
      be applied or continue analgesia can be applied by catheter&#xD;
&#xD;
        -  There has been no randomised controlled study comparing epidural versus erector spinae&#xD;
           plane block in the literature.&#xD;
&#xD;
      particiants hypothesis is that continue ESP block catheter application is non-inferior than&#xD;
      epidural catheter application in the first post-operative 48 hours regarding post-operative&#xD;
      pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on&#xD;
      post-operative pain in patients undergoing VATS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Anticipated">May 25, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>48 hour</time_frame>
    <description>difference between average VAS scores of epidural and ESP groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total fentanyl consumption</measure>
    <time_frame>48 hour</time_frame>
    <description>Total fentanyl consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS scores</measure>
    <time_frame>48 hour</time_frame>
    <description>VAS scores at rest and movement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pain, Acute</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Epidural Catheter Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be applied with epidural catheter at T 5-6 level and the patient will be injected with an epidural solution containing 15 ml 0.125% bupivacaine through this epidural catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erector Spina Block Catheter Groups</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be applied with an erector spina plane block catheter at the T 5-6 level, erector spina plane block will be applied by ultrasound guidance and when the first local anaesthetic dosage block needle is identified under the erector spina muscle 30 ml 0.25% bupivacaine (15 ml bupivacain + 15 ml saline) will be injected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound-guided erector spinae plane block catheter</intervention_name>
    <description>for postoperative pain management ultrasound-guided erector spine plane block catheter placement</description>
    <arm_group_label>Erector Spina Block Catheter Groups</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thoracic epidural catheter</intervention_name>
    <description>for postoperative pain management thoracic epidural catheter placement</description>
    <arm_group_label>Epidural Catheter Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  VATS surgery patients&#xD;
&#xD;
          -  ASA I-III group&#xD;
&#xD;
          -  without any chronic pain or anychronic analgesic usage history&#xD;
&#xD;
          -  volunteer to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients of ASA IV and above&#xD;
&#xD;
          -  patients with a BMI &gt; 30&#xD;
&#xD;
          -  patients receiving anticoagulant treatments&#xD;
&#xD;
          -  patients having previous neurologic sequellae history&#xD;
&#xD;
          -  patients having previous thoracoctomy history on the same side&#xD;
&#xD;
          -  patients having any allergy against any of the drugs used in the study (paracetamol,&#xD;
             non-steroid analgesics and opioids) will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilker Ince, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ataturk University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kübra SELVİTOPİ</last_name>
    <phone>+905067303513</phone>
    <email>drkubra25@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ataturk University</name>
      <address>
        <city>Erzurum</city>
        <state>Yakutiye</state>
        <zip>25240</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KÜBRA SELVİTOPİ, 1</last_name>
      <phone>+905067303513</phone>
      <email>drkubra25@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Türk Göğüs Kalp Damar Cer Derg 2009;17(2):139-143</citation>
  </reference>
  <reference>
    <citation>Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.</citation>
    <PMID>29033355</PMID>
  </reference>
  <reference>
    <citation>Karanikolas M, Swarm RA. Current trends in perioperative pain management. Anesthesiol Clin North Am. 2000 Sep;18(3):575-99. doi: 10.1016/s0889-8537(05)70181-4.</citation>
    <PMID>10989710</PMID>
  </reference>
  <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>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk University</investigator_affiliation>
    <investigator_full_name>Ilker Ince</investigator_full_name>
    <investigator_title>Associated Prof MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Acute Pain</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/NCT04459923
org study id: B.30.2.ATA.0.01.00/290
nct id: NCT04459923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery
      (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary,
      mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy
      can be performed with smaller incisions using video support. While being less invasive in
      comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve
      and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain
      can be more intense than expected after thoracoscopic procedures. Post-operation pain is not
      just an acute problem; 20% of the patients develop chronic incision pain after a thoracic
      surgery.

      particiants hypothesis is that continue ESP block catheter application is non-inferior than
      epidural catheter application in the first post-operative 48 hours regarding post-operative
      pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on
      post-operative pain in patients undergoing VATS.
Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery
      (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary,
      mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy
      can be performed with smaller incisions using video support. Literature shows that resections
      performed with VATS result in shorter hospital stay, lower complication rates, lower
      mortality rates and similar survivability rates in comparison to thoracotomy. While being
      less invasive in comparison to open surgery options, thoracoscopic surgery may damage the
      intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision
      area. Therefore, pain can be more intense than expected after thoracoscopic procedures.
      Post-operation pain is not just an acute problem; 20% of the patients develop chronic
      incision pain after a thoracic surgery.

      Post-operative pain is a type of acute pain which starts with surgical procedure and ends
      with tissue recovery. Eliminating this pain is one of the important purposes of anaesthesia.
      Post-operative analgesia methods may prevent the patient from feeling pain, but there has
      been no consensus regarding pain management, and generally a multi-modal approach is the most
      preferable approach. While various methods are used for post-operation analgesia, studies to
      increase patient satisfaction are still ongoing.

      Thoracic epidural analgesia (TEA) and paravertebral block are gold standard of analgesia
      methods for thoracoscopy operations, and these are widely used for VATS procedures. An
      epidural application generally performed at the level of T5-7 intervertebral space for
      thoracic surgery. While intra-operative analgesia is also provided using by an epidural
      catheter, it is also the first preference in post-operative analgesia management. It can be
      applied by continuous infusion of local anesthetic, or bolus dosages with 4-6 hours
      intervals.

      Erector spina plane block (ESPB) is a type of block applied by injection of a local
      anaesthetic into the interfacial plane under the erector spina muscle, and it is defined as
      an analgesic method for thoracic neuropathic pain in 2016. The dermatome area it covers
      varies according to the level of application. It can be applied under USG guidance and its
      application may be considered less invasive in comparison to thoracic epidural. Due to its
      easier application it can prove to be a more popular approach in the future. In thoracic
      surgeries, single-shut at the T5-6 level can be used or multiple shuts at multiple levels can
      be applied or continue analgesia can be applied by catheter

        -  There has been no randomised controlled study comparing epidural versus erector spinae
           plane block in the literature.

      particiants hypothesis is that continue ESP block catheter application is non-inferior than
      epidural catheter application in the first post-operative 48 hours regarding post-operative
      pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on
      post-operative pain in patients undergoing VATS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: VAS
time frame: 48 hour
description: difference between average VAS scores of epidural and ESP groups
measure: Total fentanyl consumption
time frame: 48 hour
description: Total fentanyl consumption.
measure: VAS scores
time frame: 48 hour
description: VAS scores at rest and movement
arm group label: Epidural Catheter Group
arm group type: Active Comparator
description: Patients will be applied with epidural catheter at T 5-6 level and the patient will be injected with an epidural solution containing 15 ml 0.125% bupivacaine through this epidural catheter
arm group label: Erector Spina Block Catheter Groups
arm group type: Active Comparator
description: Patients will be applied with an erector spina plane block catheter at the T 5-6 level, erector spina plane block will be applied by ultrasound guidance and when the first local anaesthetic dosage block needle is identified under the erector spina muscle 30 ml 0.25% bupivacaine (15 ml bupivacain + 15 ml saline) will be injected.
intervention type: Procedure
intervention name: ultrasound-guided erector spinae plane block catheter
description: for postoperative pain management ultrasound-guided erector spine plane block catheter placement
arm group label: Erector Spina Block Catheter Groups
intervention type: Procedure
intervention name: thoracic epidural catheter
description: for postoperative pain management thoracic epidural catheter placement
arm group label: Epidural Catheter Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ilker Ince, MD
role: Principal Investigator
affiliation: Ataturk University
last name: Kübra SELVİTOPİ
phone: +905067303513
email: drkubra25@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Türk Göğüs Kalp Damar Cer Derg 2009;17(2):139-143
citation: Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
PMID: 29033355
citation: Karanikolas M, Swarm RA. Current trends in perioperative pain management. Anesthesiol Clin North Am. 2000 Sep;18(3):575-99. doi: 10.1016/s0889-8537(05)70181-4.
PMID: 10989710
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
responsible party type: Principal Investigator
investigator affiliation: Ataturk University
investigator full name: Ilker Ince
investigator title: Associated Prof MD
mesh term: Pain, Postoperative
mesh term: Acute Pain
sharing ipd: No