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/NCT06011863</url>
    </required_header>
    <id_info>
      <org_study_id>10.21.2022/216</org_study_id>
      <nct_id>NCT06011863</nct_id>
    </id_info>
    <brief_title>Comparison of Pain Relief Efficacy of Epidural Analgesia and Erector Spinae Plane Block Before Thoracotomy Surgery</brief_title>
    <official_title>Effectiveness Comparison Of Preemptive Single-Dose Thoracic Epidural Analgesia And Erector Spinae Plane Block For Thoracotomy Analgesia In Thoracic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gazi Yasargil Training 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>
        In patients who will undergo open thoracic surgery, two different types of drugs will be&#xD;
        administered to volunteer patients before surgery in order to relieve postoperative pain,&#xD;
        facilitate breathing and reduce hospitalization time. The pain intensity, respiratory&#xD;
        capacity, the amount of opioid analgesic needed during and after surgery, side effects such&#xD;
        as nausea-vomiting, low blood pressure and shortness of breath will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Group Thoracic Epidural Analgesia (TEA): Thoracic Epidural Application: The epidural area&#xD;
        will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an&#xD;
        18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is&#xD;
        administered and no spinal effect is observed, a mixture of morphine and local anaesthetic&#xD;
        3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered&#xD;
        through the epidural needle at once and the epidural needle will be withdrawn and sterile&#xD;
        dressing will be applied.&#xD;
  &#xD;
          -  The mode of presentation will be face-to-face and individually.&#xD;
  &#xD;
          -  The intervention will be performed by an anaesthetist with at least 5 years of&#xD;
             experience.&#xD;
  &#xD;
          -  The stages of the intervention will be verbally explained in detail to participants&#xD;
             prior to the intervention.&#xD;
  &#xD;
          -  The patient will be taken to the operating table and electrocardiographic, oxygen&#xD;
             saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic&#xD;
             manometer will be performed.&#xD;
  &#xD;
        The intervention will be administered only once, 3-4 mg of morphine hydrochloride + 5 ml of&#xD;
        0.5 % bupivacaine + 2 ml of 0.9 % saline into the epidural space.&#xD;
  &#xD;
          -  Immediately before induction of anaesthesia, the patient will be seated and after&#xD;
             appropriate sterilisation conditions are provided, the thoracic epidural space will be&#xD;
             reached and the analgesic mixture will be given once and the space will be exited.&#xD;
  &#xD;
          -  Immediately after sterile dressing of the intervention site, the patient will be placed&#xD;
             supine and standard general anaesthesia will be applied.&#xD;
  &#xD;
          -  The intervention will be performed in the thoracic surgery room of our hospital&#xD;
             operating theatre.&#xD;
  &#xD;
        Grup Erector spinae plane block (ESP): Before induction of anaesthesia, the patient will be&#xD;
        placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis&#xD;
        conditions will be fulfilled.&#xD;
  &#xD;
        The linear ultrasonogram (USG) probe will first be placed in the sagittal plane to visualise&#xD;
        the vertebral spinous process. Then the linear probe was moved approximately 2-3 cm lateral&#xD;
        to the spinous process T5 - T6 level on the side to be operated on, and the probe will be&#xD;
        rotated 90 degrees to the longitudinal plane to visualise the transverse process. The&#xD;
        trapezius, rhomboid major and erector spinae muscles will be identified to find the correct&#xD;
        probe position. A 22 gauge, 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be&#xD;
        inserted through the skin in a cranio-caudal direction. With the needle resting on the&#xD;
        transverse process, the plane between the erector spinae muscle and the transverse process&#xD;
        will be verified by hydrodissection with 5 ml saline solution. Then, 20 ml of 0.25%&#xD;
        bupivacaine will be injected. The ESP block will be considered successful if the local&#xD;
        anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the&#xD;
        supine position and general anaesthesia will be administered.&#xD;
  &#xD;
          -  The mode of presentation will be face-to-face and individually.&#xD;
  &#xD;
          -  The intervention will be performed by an anaesthetist with at least 5 years of&#xD;
             experience.&#xD;
  &#xD;
          -  The stages of the intervention will be verbally explained in detail to participants&#xD;
             prior to the intervention.&#xD;
  &#xD;
          -  The patient will be taken to the operating table and electrocardiographic, oxygen&#xD;
             saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic&#xD;
             manometer will be performed.&#xD;
  &#xD;
          -  The intervention will be performed only once on the side of the surgical incision and 20&#xD;
             ml of 0.25% bupivacaine will be injected once into the relevant area.&#xD;
  &#xD;
          -  Immediately before induction of anaesthesia, the patient will be seated and after&#xD;
             appropriate sterilisation conditions are provided, the fascia of the erector spina&#xD;
             muscle will be reached under ultrasound guidance and the analgesic solution will be&#xD;
             given to this area only once and the cavity will be exited.&#xD;
  &#xD;
          -  Immediately after sterile dressing of the intervention site, the patient will be placed&#xD;
             supine and standard general anaesthesia will be applied.&#xD;
  &#xD;
          -  The intervention will be performed in the thoracic surgery room of our hospital&#xD;
             operating theatre.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 27, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery</time_frame>
      <description>The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between &quot;no pain&quot; and &quot;worst pain.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inspiratory spirometry test</measure>
      <time_frame>At the minute of admission to the postoperative care unit (PACU),in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery</time_frame>
      <description>The inspiratory spirometry test will be performed and the inspiratory flow rate calculated according to the number of rising balls will be recorded (1 ball = 600 ml, 2 balls = 900 ml, 3 balls = 1200 ml).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea and/or vomiting (PONV)</measure>
      <time_frame>At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery</time_frame>
      <description>Questioning about the presence/absence of nausea and/or vomiting in the postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of fentanyl used intraoperatively</measure>
      <time_frame>during surgery</time_frame>
      <description>Amount of fentanyl used intraoperatively (µg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Amount of tramadol used postoperatively</measure>
      <time_frame>during the postoperative 24 hour</time_frame>
      <description>Amount of tramadol used postoperatively (milligrams)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgery duration</measure>
      <time_frame>at the end of surgery</time_frame>
      <description>Time in hours from the start of the surgical incision until the last surgical suture is placed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anesthesia duration</measure>
      <time_frame>as soon as the patient is extubated</time_frame>
      <description>time in hours from induction of anaesthesia to extubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in intensive care</measure>
      <time_frame>It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first</time_frame>
      <description>Length of stay in intensive care unit in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first</time_frame>
      <description>days of hospitalisation after the operation</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Thoracotomy Surgery</condition>
    <arm_group>
      <arm_group_label>Group TEA (Thoracic Epidural Analgesia)</arm_group_label>
      <description>Group TEA (Thoracic Epidural Analgesia): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Grup ESP ( Erector spinae plane block)</arm_group_label>
      <description>Group ESP: Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge , 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Thoracic Epidural Analgesia</intervention_name>
      <description>Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.</description>
      <arm_group_label>Group TEA (Thoracic Epidural Analgesia)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Erector spinae plane block</intervention_name>
      <description>Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.</description>
      <arm_group_label>Grup ESP ( Erector spinae plane block)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients undergoing thoracotomy surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) I-III physical condition&#xD;
  &#xD;
            -  who were to undergo thoracotomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with acute infection,&#xD;
  &#xD;
            -  coagulation disorder,&#xD;
  &#xD;
            -  morbid obesity (Body Mass Index (BMI) &gt; 35),&#xD;
  &#xD;
            -  drug allergy&#xD;
  &#xD;
            -  history of chronic pain,&#xD;
  &#xD;
            -  long-term opioid use,&#xD;
  &#xD;
            -  history of psychiatric illness,&#xD;
  &#xD;
            -  emergency surgeries&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fatma Acil</last_name>
      <role>Principal Investigator</role>
      <affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatma Acil</last_name>
      <phone>+905337225225</phone>
      <email>acilfatma@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Zhang Y, Fu Z, Fang T, Wang K, Liu Z, Li H, Jiang W, Cao X. A comparison of the analgesic efficacy of serratus anterior plane block vs. paravertebral nerve block for video-assisted thoracic surgery: a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):134-142. doi: 10.5114/wiitm.2021.105725. Epub 2021 Apr 30.</citation>
      <PMID>35251398</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Fatma Acil</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06011863
  org study id: 10.21.2022/216
  nct id: NCT06011863
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In patients who will undergo open thoracic surgery, two different types of drugs will be
        administered to volunteer patients before surgery in order to relieve postoperative pain,
        facilitate breathing and reduce hospitalization time. The pain intensity, respiratory
        capacity, the amount of opioid analgesic needed during and after surgery, side effects such
        as nausea-vomiting, low blood pressure and shortness of breath will be evaluated.
  Group Thoracic Epidural Analgesia (TEA): Thoracic Epidural Application: The epidural area
        will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an
        18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is
        administered and no spinal effect is observed, a mixture of morphine and local anaesthetic
        3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered
        through the epidural needle at once and the epidural needle will be withdrawn and sterile
        dressing will be applied.
  
          -  The mode of presentation will be face-to-face and individually.
  
          -  The intervention will be performed by an anaesthetist with at least 5 years of
             experience.
  
          -  The stages of the intervention will be verbally explained in detail to participants
             prior to the intervention.
  
          -  The patient will be taken to the operating table and electrocardiographic, oxygen
             saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic
             manometer will be performed.
  
        The intervention will be administered only once, 3-4 mg of morphine hydrochloride + 5 ml of
        0.5 % bupivacaine + 2 ml of 0.9 % saline into the epidural space.
  
          -  Immediately before induction of anaesthesia, the patient will be seated and after
             appropriate sterilisation conditions are provided, the thoracic epidural space will be
             reached and the analgesic mixture will be given once and the space will be exited.
  
          -  Immediately after sterile dressing of the intervention site, the patient will be placed
             supine and standard general anaesthesia will be applied.
  
          -  The intervention will be performed in the thoracic surgery room of our hospital
             operating theatre.
  
        Grup Erector spinae plane block (ESP): Before induction of anaesthesia, the patient will be
        placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis
        conditions will be fulfilled.
  
        The linear ultrasonogram (USG) probe will first be placed in the sagittal plane to visualise
        the vertebral spinous process. Then the linear probe was moved approximately 2-3 cm lateral
        to the spinous process T5 - T6 level on the side to be operated on, and the probe will be
        rotated 90 degrees to the longitudinal plane to visualise the transverse process. The
        trapezius, rhomboid major and erector spinae muscles will be identified to find the correct
        probe position. A 22 gauge, 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be
        inserted through the skin in a cranio-caudal direction. With the needle resting on the
        transverse process, the plane between the erector spinae muscle and the transverse process
        will be verified by hydrodissection with 5 ml saline solution. Then, 20 ml of 0.25%
        bupivacaine will be injected. The ESP block will be considered successful if the local
        anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the
        supine position and general anaesthesia will be administered.
  
          -  The mode of presentation will be face-to-face and individually.
  
          -  The intervention will be performed by an anaesthetist with at least 5 years of
             experience.
  
          -  The stages of the intervention will be verbally explained in detail to participants
             prior to the intervention.
  
          -  The patient will be taken to the operating table and electrocardiographic, oxygen
             saturation with pulse oximetry and non-invasive blood pressure monitoring with automatic
             manometer will be performed.
  
          -  The intervention will be performed only once on the side of the surgical incision and 20
             ml of 0.25% bupivacaine will be injected once into the relevant area.
  
          -  Immediately before induction of anaesthesia, the patient will be seated and after
             appropriate sterilisation conditions are provided, the fascia of the erector spina
             muscle will be reached under ultrasound guidance and the analgesic solution will be
             given to this area only once and the cavity will be exited.
  
          -  Immediately after sterile dressing of the intervention site, the patient will be placed
             supine and standard general anaesthesia will be applied.
  
          -  The intervention will be performed in the thoracic surgery room of our hospital
             operating theatre.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Visual Analogue Scale (VAS)
  time frame: At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
  description: The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
  measure: Inspiratory spirometry test
  time frame: At the minute of admission to the postoperative care unit (PACU),in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
  description: The inspiratory spirometry test will be performed and the inspiratory flow rate calculated according to the number of rising balls will be recorded (1 ball = 600 ml, 2 balls = 900 ml, 3 balls = 1200 ml).
  measure: Postoperative nausea and/or vomiting (PONV)
  time frame: At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery
  description: Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
  measure: Amount of fentanyl used intraoperatively
  time frame: during surgery
  description: Amount of fentanyl used intraoperatively (µg)
  measure: Amount of tramadol used postoperatively
  time frame: during the postoperative 24 hour
  description: Amount of tramadol used postoperatively (milligrams)
  measure: Surgery duration
  time frame: at the end of surgery
  description: Time in hours from the start of the surgical incision until the last surgical suture is placed
  measure: Anesthesia duration
  time frame: as soon as the patient is extubated
  description: time in hours from induction of anaesthesia to extubation
  measure: Length of stay in intensive care
  time frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
  description: Length of stay in intensive care unit in days
  measure: Length of hospital stay
  time frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
  description: days of hospitalisation after the operation
  arm group label: Group TEA (Thoracic Epidural Analgesia)
  description: Group TEA (Thoracic Epidural Analgesia): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
  arm group label: Grup ESP ( Erector spinae plane block)
  description: Group ESP: Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge , 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.
  intervention type: Procedure
  intervention name: Thoracic Epidural Analgesia
  description: Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
  arm group label: Group TEA (Thoracic Epidural Analgesia)
  intervention type: Procedure
  intervention name: Erector spinae plane block
  description: Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.
  arm group label: Grup ESP ( Erector spinae plane block)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Fatma Acil
  role: Principal Investigator
  affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  last name: Fatma Acil
  phone: +905337225225
  email: acilfatma@gmail.com
  citation: Zhang Y, Fu Z, Fang T, Wang K, Liu Z, Li H, Jiang W, Cao X. A comparison of the analgesic efficacy of serratus anterior plane block vs. paravertebral nerve block for video-assisted thoracic surgery: a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):134-142. doi: 10.5114/wiitm.2021.105725. Epub 2021 Apr 30.
  PMID: 35251398
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Fatma Acil
  investigator title: Principal Investigator
  sharing ipd: Undecided