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/NCT06008002</url>
    </required_header>
    <id_info>
      <org_study_id>2023-3/1</org_study_id>
      <nct_id>NCT06008002</nct_id>
    </id_info>
    <brief_title>Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy</brief_title>
    <official_title>Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bursa Yüksek İhtisas Education and Research Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Postoperative pain is important for patient comfort, wound healing and earlier mobilisation.&#xD;
        Different procedures are used by clinicians for this purpose. Intravenous and regional&#xD;
        anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic&#xD;
        cholecystectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In our study, the investigators aimed to investigate the effectiveness of different methods&#xD;
        applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">January 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 25, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>prospective, single-blind, observational study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>NRS</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning &quot;no pain&quot; and 10 meaning &quot;the worst pain imaginable&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>tramadol consumption</measure>
      <time_frame>Postoperative 24 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>side effect profile scores</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>1. Nausea and vomiting scale (nausea-vomiting scale (NVS):&#xD;
  No nausea is present,&#xD;
  Mild nausea is present.&#xD;
  Severe nausea is present.&#xD;
  Vomiting is present) In case of a NVS score of &gt;3, an anti-emetic drug was administered.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>additional analgesic use</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>additional analgesic use</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pinprick test</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.&#xD;
  With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ramsay Sedation Scale</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>Ramsay Sedation Scale (RSS) :&#xD;
  Anxiety, agitation are present;&#xD;
  Cooperated,awake;&#xD;
  Sedated , response to commands;&#xD;
  Sleepy, immediately awoken by auditory stimulus or glabella tap;&#xD;
  Sleepy, deep response to auditory stimulus or glabella tap and&#xD;
  Sleepy, no response to auditory stimulus or glabella tap )</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Laparoscopic Cholecystectomy</condition>
    <condition>Regional Anesthesia</condition>
    <arm_group>
      <arm_group_label>Group M</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group E</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group P</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patient-controlled analgesia with tramadol</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>M-TAPA block</intervention_name>
      <description>ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed</description>
      <arm_group_label>Group M</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>EXORA block</intervention_name>
      <description>Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed</description>
      <arm_group_label>Group E</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tramadol</intervention_name>
      <description>400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.</description>
      <arm_group_label>Group E</arm_group_label>
      <arm_group_label>Group M</arm_group_label>
      <arm_group_label>Group P</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  laparoscopic cholecystectomy surgery&#xD;
  &#xD;
            -  Patients with ASA (American Society of Anaesthetists) scores I and III will be&#xD;
               included.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled Arterial Hypertension&#xD;
  &#xD;
            -  Uncontrolled Diabetes Mellitus,&#xD;
  &#xD;
            -  Mental retardation ,&#xD;
  &#xD;
            -  Antidepressant use&#xD;
  &#xD;
            -  Metabolic disorders,&#xD;
  &#xD;
            -  Bleeding diathesis&#xD;
  &#xD;
            -  Patients with a body mass index above 30.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Korgün Ökmen</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Korgün Ökmen, M.D</last_name>
      <phone>+905057081021</phone>
      <email>korgunokmen@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Korgün Ökmen</investigator_full_name>
      <investigator_title>Principal Investigator</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>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06008002
  org study id: 2023-3/1
  nct id: NCT06008002
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative pain is important for patient comfort, wound healing and earlier mobilisation.
        Different procedures are used by clinicians for this purpose. Intravenous and regional
        anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic
        cholecystectomy.
  In our study, the investigators aimed to investigate the effectiveness of different methods
        applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, single-blind, observational study
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: NRS
  time frame: Postoperative 24 hours
  description: The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
  measure: tramadol consumption
  time frame: Postoperative 24 hours
  measure: side effect profile scores
  time frame: Postoperative 24 hours
  description: 1. Nausea and vomiting scale (nausea-vomiting scale (NVS):
  No nausea is present,
  Mild nausea is present.
  Severe nausea is present.
  Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
  measure: additional analgesic use
  time frame: Postoperative 24 hours
  description: additional analgesic use
  measure: pinprick test
  time frame: Postoperative 24 hours
  description: The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients.
  With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.
  measure: Ramsay Sedation Scale
  time frame: Postoperative 24 hours
  description: Ramsay Sedation Scale (RSS) :
  Anxiety, agitation are present;
  Cooperated,awake;
  Sedated , response to commands;
  Sleepy, immediately awoken by auditory stimulus or glabella tap;
  Sleepy, deep response to auditory stimulus or glabella tap and
  Sleepy, no response to auditory stimulus or glabella tap )
  arm group label: Group M
  arm group type: Active Comparator
  description: ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
  arm group label: Group E
  arm group type: Active Comparator
  description: Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block
  arm group label: Group P
  arm group type: Active Comparator
  description: Patient-controlled analgesia with tramadol
  intervention type: Procedure
  intervention name: M-TAPA block
  description: ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed
  arm group label: Group M
  intervention type: Procedure
  intervention name: EXORA block
  description: Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
  arm group label: Group E
  intervention type: Drug
  intervention name: Tramadol
  description: 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
  arm group label: Group E
  arm group label: Group M
  arm group label: Group P
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Korgün Ökmen
  role: Principal Investigator
  affiliation: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
  last name: Korgün Ökmen, M.D
  phone: +905057081021
  email: korgunokmen@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
  investigator full name: Korgün Ökmen
  investigator title: Principal Investigator
  mesh term: Pain, Postoperative
  mesh term: Tramadol
  sharing ipd: No