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/NCT05999253</url>
    </required_header>
    <id_info>
      <org_study_id>05.05.2023/373</org_study_id>
      <nct_id>NCT05999253</nct_id>
    </id_info>
    <brief_title>Comparison of the Efficacy of Thoracolumbar Interfascial Plane Block and Erector Spina Plane Block in Lumbar Discectomy</brief_title>
    <official_title>Comparison of the Effects of Modified Thoracolumbar Interfacial Plane (mTLIP) Block and Erector Spina Plane Block on Postoperative Pain and Opioid Analgesic Consumption in Patients Undergoing Lumbar Discectomy for Lumbar Disc Herniation</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>
        Patients who will undergo herniated disc surgery have serious pain after surgery. In order to&#xD;
        minimise this pain and to ensure that they recover more quickly and use less morphine-derived&#xD;
        painkillers, we aim to apply two types of painkiller injections before surgery. For this&#xD;
        purpose, it is planned to apply painkiller injections on both sides of the level of the&#xD;
        herniated disc with sedation before the operation. Afterwards, herniated disc surgery will be&#xD;
        performed under general anaesthesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment&#xD;
        of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is&#xD;
        placed in the interfascial plane of these two muscles and local anesthesic solution is&#xD;
        appliced.&#xD;
  &#xD;
          -  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25%&#xD;
             bupivacaine will be used)&#xD;
  &#xD;
          -  to be administered only approximately 20-30 minutes before the onset of anaesthesia.&#xD;
  &#xD;
          -  only once in the preoperative block room approximately 20-30 minutes before induction of&#xD;
             anaesthesia&#xD;
  &#xD;
          -  plane block applications will be performed by anaesthesiologists with at least 5 years&#xD;
             of experience&#xD;
  &#xD;
          -  patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening&#xD;
             from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS&#xD;
             pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.&#xD;
  &#xD;
          -  plane blocks will be applied under ultrasound guidance.&#xD;
  &#xD;
          -  plane block applications will be performed by anaesthesiologists with at least 5 years&#xD;
             of experience&#xD;
  &#xD;
          -  Postoperative evaluations of patients will be performed face to face. Patients will be&#xD;
             routinely administered 1 g paracetamol intravenously at 8 hour intervals in the&#xD;
             postoperative period. 100 mg tramadol intravenously will be administered if their pain&#xD;
             is above VAS 4 despite this.&#xD;
  &#xD;
          -  This study was followed up in the neurosurgery unit of SBU Gazi Yasargil Training and&#xD;
             Research Hospital.&#xD;
  &#xD;
          -  Patients were sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the&#xD;
             preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was&#xD;
             administered bilaterally on each side under ultrasound guidance. After the block&#xD;
             application, the patient was taken to the operating room and standard general&#xD;
             anaesthesia was applied.&#xD;
  &#xD;
        Patients will be monitored for pain and side effects at the neurosurgery unit , 1st hour, 2nd&#xD;
        hour, 4th hour, 8th hour and 24th hour in the postoperative period.&#xD;
  &#xD;
        - Both plan blocks are applied for analgesia in the postoperative period and aim to reduce&#xD;
        opioid consumption in the postoperative period.&#xD;
  &#xD;
        Erector spinae plane block (ESP): After determining the vertebral spinal process and&#xD;
        trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block&#xD;
        needle is advanced in the cranio-caudal direction with an in plane approach and local&#xD;
        anaesthetic solution is applied to the plane between the erector spinae muscle and the&#xD;
        transverse process when the needle rests on the transverse process.&#xD;
  &#xD;
          -  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25%&#xD;
             bupivacaine will be used)&#xD;
  &#xD;
          -  to be administered only approximately 20-30 minutes before the onset of anaesthesia.&#xD;
  &#xD;
          -  only once in the preoperative block room approximately 20-30 minutes before induction of&#xD;
             anaesthesia&#xD;
  &#xD;
          -  plane block applications will be performed by anaesthesiologists with at least 5 years&#xD;
             of experience&#xD;
  &#xD;
          -  patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening&#xD;
             from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS&#xD;
             pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.&#xD;
  &#xD;
          -  plane blocks will be applied under ultrasound guidance.&#xD;
  &#xD;
          -  plane block applications will be performed by anaesthesiologists with at least 5 years&#xD;
             of experience&#xD;
  &#xD;
          -  Postoperative evaluations of patients will be performed face to face.&#xD;
  &#xD;
        Statistical methods / analysis: G-Power version 3.1.9.4 (Universität Kiel, Germany) program&#xD;
        was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as&#xD;
        0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted&#xD;
        as N2/N1:1,12. The minimum number of patients to be included in the study was calculated as&#xD;
        42.&#xD;
  &#xD;
        SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for other statistical analyses.&#xD;
        Statistical data were expressed as mean and standard deviation, while categorical data were&#xD;
        expressed as frequency and percentage. Comparison of categorical data in the groups was done&#xD;
        with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if&#xD;
        the numerical data fit the normal distribution. While the data fitting the normal&#xD;
        distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to&#xD;
        compare the data differ from the normal distribution. p &lt;0.05 was considered statistically&#xD;
        significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 29, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours</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;&#xD;
  Low back pain and leg pain as an extension of the traveling nerve assessed using visual pain scores (VAS) will be evaluated</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sedation- agitation level</measure>
      <time_frame>After extubation]</time_frame>
      <description>The Riker Sedation- Agitation Scale (RSAS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior.&#xD;
  Riker sedation-agitation Scale:1- Unarousable, 2 -Very Sedated, 3- Sedated, 4 Calm and Cooperative, 5 -Agitated, 6 -Very Agitated, 7 -Dangerous Agitation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nausea-vomiting</measure>
      <time_frame>postoperative 1st, 2nd, 4th, 8th and 24th hours</time_frame>
      <description>-Postoperative nausea and vomiting will be assessed using a 100 mm Visual Analogue Scale (VAS):&#xD;
  1- severe nausea (VAS&gt;70 mm), 2- moderate nausea (50&lt;VAS&lt;70 mm), 3- mild nausea (VAS &lt;50 mm).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic, diastolic and mean arterial pressure monitoring</measure>
      <time_frame>before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery</time_frame>
      <description>Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>heart rate monitoring</measure>
      <time_frame>before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery</time_frame>
      <description>the measurement will be obtained by electrocardiographic monitoring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of fentanyl consumed during the operation</measure>
      <time_frame>during surgery</time_frame>
      <description>micrograms of fentanyl consumed</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>at the end of anaesthesia]</time_frame>
      <description>time in hours from induction of anaesthesia to extubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction assessmen</measure>
      <time_frame>at the end of 24 hours postoperatively</time_frame>
      <description>Patients' satisfaction with the quality of pain management will be assessed at 24 hours postoperatively using the following scale:&#xD;
  1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfied; 5 = very satisfied</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Lumbar Disc Herniation</condition>
    <arm_group>
      <arm_group_label>Modified thoracolumbar plane block (mTLIP)</arm_group_label>
      <description>Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.&#xD;
  Patients will be induced with standard general anesthesia and turned to the prone position.&#xD;
  Before the surgical incision, 20 ml of 0.25% bupivacaine 0.25% will be administered bilaterally under ultrasound guidance only once.&#xD;
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)&#xD;
  Plane block applications will be performed by anaesthesiologists with at least 5 years of experience</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Erector spinae plane block (ESP)</arm_group_label>
      <description>Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.&#xD;
  Patients will be induced with standard general anesthesia and turned to the prone position.&#xD;
  Before the surgical incision, 20 ml of 0.25% bupivacaine will be administered bilaterally under ultrasound guidance only once.&#xD;
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)&#xD;
  Plane block applications will be performed by anaesthesiologists with at least 5 years of experience</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Modified thoracolumbar plane block (mTLIP)</intervention_name>
      <description>Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.&#xD;
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)&#xD;
  to be administered only approximately 20-30 minutes before the onset of anaesthesia.</description>
      <arm_group_label>Modified thoracolumbar plane block (mTLIP)</arm_group_label>
      <other_name>Plane block</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Erector spinae plane block (ESP)</intervention_name>
      <description>Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.&#xD;
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)&#xD;
  to be administered only approximately 20-30 minutes before the onset of anaesthesia</description>
      <arm_group_label>Erector spinae plane block (ESP)</arm_group_label>
      <other_name>Plane block</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients to be operated for 1 or 2 level lumbar disc herniation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between 18-70 years of age, ASA I-III, scheduled for Lumbar Disc Herniation&#xD;
               operation under general anaesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA &gt;III body mass index (BMI) &gt; 35 kg/m2 known allergy to local anaesthetics presence&#xD;
               of preoperative chronic pain presence of coagulopathy those who are unable to give&#xD;
               written consent non-voluntary patients&#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>Cem K. Kaçar, Assoc.Prof</last_name>
      <role>Study Director</role>
      <affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fatma Acil, M.D.</last_name>
      <phone>+905337225225</phone>
      <email>acilfatma@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Ciftci B, Ekinci M, Celik EC, Yayik AM, Aydin ME, Ahiskalioglu A. Ultrasound-Guided Erector Spinae Plane Block versus Modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study. World Neurosurg. 2020 Dec;144:e849-e855. doi: 10.1016/j.wneu.2020.09.077. Epub 2020 Sep 18.</citation>
      <PMID>32956890</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>Anesthesiology and Reanimation Spesialist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Displacement</mesh_term>
      <mesh_term>Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>after de-identification; all individual participant data collected during the research and the primary and secondary outcomes of the study.&#xD;
  data can be shared immediately after publication, no end date set.&#xD;
  case-by-case basis at the discretion of Primary Sponsor&#xD;
  data can be access subject to approvals by Principal Investigator (e-mail: fatma.acil@saglik.gov.tr)</ipd_description>
    </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/NCT05999253
  org study id: 05.05.2023/373
  nct id: NCT05999253
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients who will undergo herniated disc surgery have serious pain after surgery. In order to
        minimise this pain and to ensure that they recover more quickly and use less morphine-derived
        painkillers, we aim to apply two types of painkiller injections before surgery. For this
        purpose, it is planned to apply painkiller injections on both sides of the level of the
        herniated disc with sedation before the operation. Afterwards, herniated disc surgery will be
        performed under general anaesthesia.
  Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment
        of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is
        placed in the interfascial plane of these two muscles and local anesthesic solution is
        appliced.
  
          -  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25%
             bupivacaine will be used)
  
          -  to be administered only approximately 20-30 minutes before the onset of anaesthesia.
  
          -  only once in the preoperative block room approximately 20-30 minutes before induction of
             anaesthesia
  
          -  plane block applications will be performed by anaesthesiologists with at least 5 years
             of experience
  
          -  patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening
             from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS
             pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
  
          -  plane blocks will be applied under ultrasound guidance.
  
          -  plane block applications will be performed by anaesthesiologists with at least 5 years
             of experience
  
          -  Postoperative evaluations of patients will be performed face to face. Patients will be
             routinely administered 1 g paracetamol intravenously at 8 hour intervals in the
             postoperative period. 100 mg tramadol intravenously will be administered if their pain
             is above VAS 4 despite this.
  
          -  This study was followed up in the neurosurgery unit of SBU Gazi Yasargil Training and
             Research Hospital.
  
          -  Patients were sedated with 1 mg midazolam and 50 mcg fentanyl intravenously in the
             preoperative preparation room in the operating room and 20 ml of 0.25% bupivacaine was
             administered bilaterally on each side under ultrasound guidance. After the block
             application, the patient was taken to the operating room and standard general
             anaesthesia was applied.
  
        Patients will be monitored for pain and side effects at the neurosurgery unit , 1st hour, 2nd
        hour, 4th hour, 8th hour and 24th hour in the postoperative period.
  
        - Both plan blocks are applied for analgesia in the postoperative period and aim to reduce
        opioid consumption in the postoperative period.
  
        Erector spinae plane block (ESP): After determining the vertebral spinal process and
        trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block
        needle is advanced in the cranio-caudal direction with an in plane approach and local
        anaesthetic solution is applied to the plane between the erector spinae muscle and the
        transverse process when the needle rests on the transverse process.
  
          -  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25%
             bupivacaine will be used)
  
          -  to be administered only approximately 20-30 minutes before the onset of anaesthesia.
  
          -  only once in the preoperative block room approximately 20-30 minutes before induction of
             anaesthesia
  
          -  plane block applications will be performed by anaesthesiologists with at least 5 years
             of experience
  
          -  patients' intraoperative fentanyl consumption, agitation-sedation scores on awakening
             from anaesthesia, tramadol consumption in the postoperative 24 hours, postoperative VAS
             pain scores, and side effects such as postoperative nausea-vomiting will be evaluated.
  
          -  plane blocks will be applied under ultrasound guidance.
  
          -  plane block applications will be performed by anaesthesiologists with at least 5 years
             of experience
  
          -  Postoperative evaluations of patients will be performed face to face.
  
        Statistical methods / analysis: G-Power version 3.1.9.4 (Universität Kiel, Germany) program
        was used to calculate the sample size. The two-tailed alpha error was taken as 0.05, power as
        0.80 and effect size as 0.8, and based on a previous study the allocation ratio was accepted
        as N2/N1:1,12. The minimum number of patients to be included in the study was calculated as
        42.
  
        SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA) was used for other statistical analyses.
        Statistical data were expressed as mean and standard deviation, while categorical data were
        expressed as frequency and percentage. Comparison of categorical data in the groups was done
        with Chi-square, the results were given as %n. Shapiro-Wilk tests were used to determine if
        the numerical data fit the normal distribution. While the data fitting the normal
        distribution were evaluated with the Student's t-test. Mann- Whitney U tests were used to
        compare the data differ from the normal distribution. p <0.05 was considered statistically
        significant.
  observational model: Cohort
  time perspective: Prospective
  measure: Visual Analogue Scale (VAS)
  time frame: assessed at postoperative 1st, 2nd, 4th, 8th and 24th hours
  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."
  Low back pain and leg pain as an extension of the traveling nerve assessed using visual pain scores (VAS) will be evaluated
  measure: Sedation- agitation level
  time frame: After extubation]
  description: The Riker Sedation- Agitation Scale (RSAS): identifies seven levels of sedation and agitation, which range from dangerous agitation to deep sedation, with a thorough description of patient behavior.
  Riker sedation-agitation Scale:1- Unarousable, 2 -Very Sedated, 3- Sedated, 4 Calm and Cooperative, 5 -Agitated, 6 -Very Agitated, 7 -Dangerous Agitation
  measure: Nausea-vomiting
  time frame: postoperative 1st, 2nd, 4th, 8th and 24th hours
  description: -Postoperative nausea and vomiting will be assessed using a 100 mm Visual Analogue Scale (VAS):
  1- severe nausea (VAS>70 mm), 2- moderate nausea (50<VAS<70 mm), 3- mild nausea (VAS <50 mm).
  measure: Systolic, diastolic and mean arterial pressure monitoring
  time frame: before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
  description: Blood pressure will be measured with a non-invasive automatic pneumatic cuff in the operating theatre.
  measure: heart rate monitoring
  time frame: before the start of surgery, at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 40 minutes, 50th minutes, 60 minutes after the start of surgery
  description: the measurement will be obtained by electrocardiographic monitoring
  measure: amount of fentanyl consumed during the operation
  time frame: during surgery
  description: micrograms of fentanyl consumed
  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: at the end of anaesthesia]
  description: time in hours from induction of anaesthesia to extubation
  measure: patient satisfaction assessmen
  time frame: at the end of 24 hours postoperatively
  description: Patients' satisfaction with the quality of pain management will be assessed at 24 hours postoperatively using the following scale:
  1 = very dissatisfied; 2 = quite dissatisfied; 3 = moderate; 4 = quite satisfied; 5 = very satisfied
  arm group label: Modified thoracolumbar plane block (mTLIP)
  description: Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.
  Patients will be induced with standard general anesthesia and turned to the prone position.
  Before the surgical incision, 20 ml of 0.25% bupivacaine 0.25% will be administered bilaterally under ultrasound guidance only once.
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
  Plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  arm group label: Erector spinae plane block (ESP)
  description: Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.
  Patients will be induced with standard general anesthesia and turned to the prone position.
  Before the surgical incision, 20 ml of 0.25% bupivacaine will be administered bilaterally under ultrasound guidance only once.
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
  Plane block applications will be performed by anaesthesiologists with at least 5 years of experience
  intervention type: Procedure
  intervention name: Modified thoracolumbar plane block (mTLIP)
  description: Modified thoracolumbar plane block (mTLIP): under ultrasound-guided, the lateral compartment of the longissimus muscle and iliocostal muscle muscles are imagined and the block needle is placed in the interfascial plane of these two muscles and local anesthesic solution is appliced.
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
  to be administered only approximately 20-30 minutes before the onset of anaesthesia.
  arm group label: Modified thoracolumbar plane block (mTLIP)
  other name: Plane block
  intervention type: Procedure
  intervention name: Erector spinae plane block (ESP)
  description: Erector spinae plane block (ESP): After determining the vertebral spinal process and trapezius, rhomboid major and erector spinae muscles with ultrasound guidance, the block needle is advanced in the cranio-caudal direction with an in plane approach and local anaesthetic solution is applied to the plane between the erector spinae muscle and the transverse process when the needle rests on the transverse process.
  20 ml of 0.25% bupivacaine will be used on each side (total of 40 ml of 0.25% bupivacaine will be used)
  to be administered only approximately 20-30 minutes before the onset of anaesthesia
  arm group label: Erector spinae plane block (ESP)
  other name: Plane block
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Cem K. Kaçar, Assoc.Prof
  role: Study Director
  affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  last name: Fatma Acil, M.D.
  phone: +905337225225
  email: acilfatma@gmail.com
  citation: Ciftci B, Ekinci M, Celik EC, Yayik AM, Aydin ME, Ahiskalioglu A. Ultrasound-Guided Erector Spinae Plane Block versus Modified-Thoracolumbar Interfascial Plane Block for Lumbar Discectomy Surgery: A Randomized, Controlled Study. World Neurosurg. 2020 Dec;144:e849-e855. doi: 10.1016/j.wneu.2020.09.077. Epub 2020 Sep 18.
  PMID: 32956890
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Fatma Acil
  investigator title: Anesthesiology and Reanimation Spesialist
  mesh term: Intervertebral Disc Displacement
  mesh term: Hernia
  sharing ipd: Undecided
  ipd description: after de-identification; all individual participant data collected during the research and the primary and secondary outcomes of the study.
  data can be shared immediately after publication, no end date set.
  case-by-case basis at the discretion of Primary Sponsor
  data can be access subject to approvals by Principal Investigator (e-mail: fatma.acil@saglik.gov.tr)