<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/NCT04443556</url>
  </required_header>
  <id_info>
    <org_study_id>RISS THORACOTOMY</org_study_id>
    <nct_id>NCT04443556</nct_id>
  </id_info>
  <brief_title>Effect of Continue RISS Block in Thoracotomy</brief_title>
  <official_title>Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konya Meram State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Meram State 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>
      Thoracotomy is one of the most painful surgery. Acute postoperative pain increases&#xD;
      postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic&#xD;
      pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and&#xD;
      subserratus plane (RISS) block by inserting a catheter under direct vision for controlling&#xD;
      acute thoracotomy pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy&#xD;
      needle into fascial planes for continue RISS block. First catheter tip will be place towards&#xD;
      the interfascial planes between the rhomboid major and intercostal muscles and the second&#xD;
      catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be&#xD;
      injected through the catheters for 48 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">February 15, 2021</completion_date>
  <primary_completion_date type="Actual">January 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>postoperative 48 hour</time_frame>
    <description>Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic consumption</measure>
    <time_frame>Postoperative 48 hour</time_frame>
    <description>Total opioid consumption after the surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Thoracotomy</condition>
  <arm_group>
    <arm_group_label>Group Rhomboid Intercostal and Subserratus Plane Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standart postoperative analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol</intervention_name>
    <description>Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.</description>
    <arm_group_label>Group Rhomboid Intercostal and Subserratus Plane Block</arm_group_label>
    <other_name>Local anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IV PCA</intervention_name>
    <description>An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Group Rhomboid Intercostal and Subserratus Plane Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age undergoing elective thoracic surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I-III grade&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  History of psychiatric and cognitive disorders.&#xD;
&#xD;
          -  Patients allergic to the drugs used in the study&#xD;
&#xD;
          -  Emergent surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Konya Education and Training Hospital</name>
      <address>
        <city>Konya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>April 18, 2021</last_update_submitted>
  <last_update_submitted_qc>April 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation>
    <investigator_full_name>Betul Kozanhan</investigator_full_name>
    <investigator_title>Ass.Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04443556
org study id: RISS THORACOTOMY
nct id: NCT04443556
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thoracotomy is one of the most painful surgery. Acute postoperative pain increases
      postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic
      pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and
      subserratus plane (RISS) block by inserting a catheter under direct vision for controlling
      acute thoracotomy pain.
Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy
      needle into fascial planes for continue RISS block. First catheter tip will be place towards
      the interfascial planes between the rhomboid major and intercostal muscles and the second
      catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be
      injected through the catheters for 48 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: postoperative pain
time frame: postoperative 48 hour
description: Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
measure: Analgesic consumption
time frame: Postoperative 48 hour
description: Total opioid consumption after the surgery
arm group label: Group Rhomboid Intercostal and Subserratus Plane Block
arm group type: Active Comparator
description: Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block
arm group label: Control Group
arm group type: Other
description: Standart postoperative analgesia
intervention type: Drug
intervention name: Tramadol
description: Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
arm group label: Group Rhomboid Intercostal and Subserratus Plane Block
other name: Local anesthetic
intervention type: Other
intervention name: IV PCA
description: An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
arm group label: Control Group
arm group label: Group Rhomboid Intercostal and Subserratus Plane Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Konya Meram State Hospital
investigator full name: Betul Kozanhan
investigator title: Ass.Prof.
mesh term: Pain, Postoperative
mesh term: Tramadol
mesh term: Anesthetics
mesh term: Anesthetics, Local