<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/NCT04428216</url>
  </required_header>
  <id_info>
    <org_study_id>Medipol Hospital 13</org_study_id>
    <nct_id>NCT04428216</nct_id>
  </id_info>
  <brief_title>Rhomboid Intercostal Block for Video Assisted Thoracic Surgery</brief_title>
  <official_title>The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block for Pain Management Following Video Assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medipol 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 thoracic surgery (VATS) has recently been evaluated as the standard surgical&#xD;
      procedure for lung surgery. Analgesia management is very important for these patients in&#xD;
      postoperative period since insufficient analgesia can cause pulmonary complications such as&#xD;
      atelectasis, pneumonia and increased oxygen consumption.&#xD;
&#xD;
      Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et&#xD;
      al. It has been reported that RIB may provide effective analgesia management for several&#xD;
      surgeries like thoracotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently&#xD;
      been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS&#xD;
      prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low&#xD;
      complication risk. Although VATS is less painful than thoracotomy, patients may feel severe&#xD;
      pain during the first hours at postoperative period. Analgesia management is very important&#xD;
      for these patients in postoperative period since insufficient analgesia can cause pulmonary&#xD;
      complications such as atelectasis, pneumonia and increased oxygen consumption.&#xD;
&#xD;
      Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et&#xD;
      al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal&#xD;
      muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets&#xD;
      both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides&#xD;
      analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide&#xD;
      effective analgesia management for several surgeries like thoracotomy.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block&#xD;
      compared to no intervention control group for postoperative analgesia management after VATS.&#xD;
      The primary aim is to compare postoperative opioid consumption and the secondary aim is to&#xD;
      evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic&#xD;
      reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">June 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 30, 2022</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>
    <intervention_model_description>There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The anesthesiologist who performs postoperative pain evaluation will not know the group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours</time_frame>
    <description>The primary aim is to compare perioperative and postoperative opioid consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain scores (Visual analogue scores-VAS)</measure>
    <time_frame>Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.</time_frame>
    <description>Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Group RIB = Rhomboid intercostal block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C = Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group RIB</intervention_name>
    <description>In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.</description>
    <arm_group_label>Group RIB = Rhomboid intercostal block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
          -  Scheduled for VATS under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of bleeding diathesis,&#xD;
&#xD;
          -  receiving anticoagulant treatment,&#xD;
&#xD;
          -  known local anesthetics and opioid allergy,&#xD;
&#xD;
          -  infection of the skin at the site of the needle puncture,&#xD;
&#xD;
          -  pregnancy or lactation,&#xD;
&#xD;
          -  patients who do not accept the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bagcilar</state>
        <zip>34070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.</citation>
    <PMID>27291611</PMID>
  </reference>
  <reference>
    <citation>Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The usage of single-shot ultrasound guided rhomboid intercostal block for analgesia after thoracotomy: Clinical experience in two patients. J Clin Anesth. 2019 Sep;56:98-99. doi: 10.1016/j.jclinane.2019.01.032. Epub 2019 Jan 29. No abstract available.</citation>
    <PMID>30708149</PMID>
  </reference>
  <reference>
    <citation>Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.</citation>
    <PMID>30851503</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 10, 2022</last_update_submitted>
  <last_update_submitted_qc>August 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medipol University</investigator_affiliation>
    <investigator_full_name>Bahadir Ciftci</investigator_full_name>
    <investigator_title>Primary researcher</investigator_title>
  </responsible_party>
  <keyword>Video Assisted Thoracic Surgery</keyword>
  <keyword>Postoperative pain management</keyword>
  <keyword>Rhomboid intercostal block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not plan to share IPD</ipd_description>
  </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/NCT04428216
org study id: Medipol Hospital 13
nct id: NCT04428216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical
      procedure for lung surgery. Analgesia management is very important for these patients in
      postoperative period since insufficient analgesia can cause pulmonary complications such as
      atelectasis, pneumonia and increased oxygen consumption.

      Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et
      al. It has been reported that RIB may provide effective analgesia management for several
      surgeries like thoracotomy.
Following Video Assisted Thoracic Surgery Video assisted thoracic surgery (VATS) has recently
      been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS
      prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low
      complication risk. Although VATS is less painful than thoracotomy, patients may feel severe
      pain during the first hours at postoperative period. Analgesia management is very important
      for these patients in postoperative period since insufficient analgesia can cause pulmonary
      complications such as atelectasis, pneumonia and increased oxygen consumption.

      Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et
      al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal
      muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets
      both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides
      analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide
      effective analgesia management for several surgeries like thoracotomy.

      The aim of this study is to evaluate the efficacy US-guided Rhomboid intercostal block
      compared to no intervention control group for postoperative analgesia management after VATS.
      The primary aim is to compare postoperative opioid consumption and the secondary aim is to
      evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic
      reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are two models for this study. The first group is rhomboid intercostal block group. The second one is no intervention control group
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The anesthesiologist who performs postoperative pain evaluation will not know the group.
measure: Opioid consumption
time frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
description: The primary aim is to compare perioperative and postoperative opioid consumption
measure: Pain scores (Visual analogue scores-VAS)
time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.
description: Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded
arm group label: Group RIB = Rhomboid intercostal block group
arm group type: Active Comparator
description: In group RIB, RIB block will be performed with patients in the lateral decubitus position. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injected into the fascial plane.
arm group label: Group C = Control group
arm group type: No Intervention
description: Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
intervention type: Other
intervention name: Group RIB
description: In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
arm group label: Group RIB = Rhomboid intercostal block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Elsharkawy H, Saifullah T, Kolli S, Drake R. Rhomboid intercostal block. Anaesthesia. 2016 Jul;71(7):856-7. doi: 10.1111/anae.13498. No abstract available.
PMID: 27291611
citation: Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. The usage of single-shot ultrasound guided rhomboid intercostal block for analgesia after thoracotomy: Clinical experience in two patients. J Clin Anesth. 2019 Sep;56:98-99. doi: 10.1016/j.jclinane.2019.01.032. Epub 2019 Jan 29. No abstract available.
PMID: 30708149
citation: Yayik AM, Ahiskalioglu A, Ates I, Ahiskalioglu EO, Cinal H. Ultrasound guided bilateral rhomboid intercostal block for breast reduction surgery. J Clin Anesth. 2019 Nov;57:38-39. doi: 10.1016/j.jclinane.2019.03.001. Epub 2019 Mar 6. No abstract available.
PMID: 30851503
responsible party type: Principal Investigator
investigator affiliation: Medipol University
investigator full name: Bahadir Ciftci
investigator title: Primary researcher
mesh term: Lung Diseases
sharing ipd: No
ipd description: We will not plan to share IPD