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/NCT06017401</url>
    </required_header>
    <id_info>
      <org_study_id>UludagU-KCebeci-001</org_study_id>
      <nct_id>NCT06017401</nct_id>
    </id_info>
    <brief_title>Oblique Subcostal Transversus Abdominis Plane Block Versus Transmuscular Quadratus Lumborum Block for Pain Management in Laparoscopic Gynecological Surgery</brief_title>
    <official_title>Comparison of The Efficacy of Oblique Subcostal Transversus Abdominis Plane Block and Transmuscular Quadratus Lumborum Block on Postoperative Analgesia and Quality of Recovery in Patients Undergoing Laparoscopic Gynecological Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uludag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uludag 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>
        Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this&#xD;
        study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus&#xD;
        abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular&#xD;
        quadratus lumborum block (TQLB).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery,&#xD;
        American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the&#xD;
        range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the&#xD;
        study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB&#xD;
        group and TQL block will be performed for TQLB group. Patients will be administered&#xD;
        postoperative 4x500 mg iv paracetamol as needed (if Numerical rating scale (NRS) score is 4&#xD;
        or higher). If the NRS score remains at 4 or higher 30 minutes after paracetamol&#xD;
        administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily&#xD;
        maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption&#xD;
        within the first 24 hours after surgery. The secondary outcome is to compare the time to the&#xD;
        first postoperative analgesic requirement, NRS scores at rest and on movement, and assess the&#xD;
        impact of these two blocks on the quality of recovery using the QOR-15 scale&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 18, 2023</start_date>
    <completion_date type="Anticipated">February 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 18, 2023</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>Supportive Care</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative 24 hours total analgesic consumption</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The time to the first analgesic requirement, NRS scores and QOR-15 scores of the patients</measure>
      <time_frame>24 hours postoperatively</time_frame>
      <description>The secondary outcome is to compare the time to the first postoperative analgesic requirement, NRS scores at 0, 30th min and 1, 2, 6, 12, 18, 24th hours at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QoR-15 scale.&#xD;
  A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.&#xD;
  The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>Group OSTAP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group TQLB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Oblique Subcostal Transversus Abdominis Plane Block</intervention_name>
      <description>The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia</description>
      <arm_group_label>Group OSTAP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transmuscular Quadratus Lumborum Block</intervention_name>
      <description>The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia</description>
      <arm_group_label>Group TQLB</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages of 18-65&#xD;
  &#xD;
            -  Patients who will undergo laparoscopic gynecological surgery&#xD;
  &#xD;
            -  ASA I-II-III patients&#xD;
  &#xD;
            -  Body Mass Index (BMI) in the range of 18-25 kg/m²&#xD;
  &#xD;
            -  Patients who will undergo surgery using 3 or 4 trocars&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA IV-V&#xD;
  &#xD;
            -  Patients with a known or suspected allergy to local anesthetics&#xD;
  &#xD;
            -  Coagulopathy&#xD;
  &#xD;
            -  Injection site infection&#xD;
  &#xD;
            -  Severe neurological or psychiatric disorders&#xD;
  &#xD;
            -  Severe cardiovascular disease&#xD;
  &#xD;
            -  Liver failure&#xD;
  &#xD;
            -  Kidney failure (glomerular filtration rate &lt;15 ml/min/m²)&#xD;
  &#xD;
            -  Chronic opioid use (&gt;6 months)&#xD;
  &#xD;
            -  Surgical durations less than 45 minutes or greater than 120 minutes&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bursa Uludag University Faculty of Medicine</name>
        <address>
          <city>Bursa</city>
          <zip>16059</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kübra CEBECI</last_name>
        <phone>+905532813646</phone>
        <email>kubracebeci@uludag.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uludag University</investigator_affiliation>
      <investigator_full_name>Kübra Cebeci</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Postoperative pain</keyword>
    <keyword>Pain management</keyword>
    <keyword>Oblique subcostal transversus abdominis plane block</keyword>
    <keyword>Transmuscular quadratus lumborum block</keyword>
    <keyword>Quality of Recovery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017401
  org study id: UludagU-KCebeci-001
  nct id: NCT06017401
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Laparoscopic gynecological surgery causes postoperative pain.The primary objective of this
        study is to compare the effect of ultrasound (US)-guided oblique subcostal transversus
        abdominis plane block (OSTAP) on 24-hour total analgesic consumption with transmuscular
        quadratus lumborum block (TQLB).
  Patients between the ages of 18-65, who will undergo laparoscopic gynecological surgery,
        American Society of Anesthesiologists (ASA) class I-II-III, Body Mass Index (BMI) in the
        range of 18-25 kg/m², and who will use 3 or 4 trocar for surgery will be included in the
        study. Patients will be randomized into two groups. OSTAP block will be performed for OSTAPB
        group and TQL block will be performed for TQLB group. Patients will be administered
        postoperative 4x500 mg iv paracetamol as needed (if Numerical rating scale (NRS) score is 4
        or higher). If the NRS score remains at 4 or higher 30 minutes after paracetamol
        administration, 1 mg/kg iv tramadol will be administered as a rescue analgesic (with a daily
        maximum dose of 400 mg). The primary outcome is to compare the total analgesic consumption
        within the first 24 hours after surgery. The secondary outcome is to compare the time to the
        first postoperative analgesic requirement, NRS scores at rest and on movement, and assess the
        impact of these two blocks on the quality of recovery using the QOR-15 scale
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Postoperative 24 hours total analgesic consumption
  time frame: 24 hours postoperatively
  description: The primary outcome is to compare the total consumption of paracetamol and tramadol within the first 24 hours after surgery.
  measure: The time to the first analgesic requirement, NRS scores and QOR-15 scores of the patients
  time frame: 24 hours postoperatively
  description: The secondary outcome is to compare the time to the first postoperative analgesic requirement, NRS scores at 0, 30th min and 1, 2, 6, 12, 18, 24th hours at rest and on movement, and assess the impact of these two blocks on the quality of recovery using the QoR-15 scale.
  A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
  The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery.
  arm group label: Group OSTAP
  arm group type: Active Comparator
  description: The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
  arm group label: Group TQLB
  arm group type: Active Comparator
  description: The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
  intervention type: Procedure
  intervention name: Oblique Subcostal Transversus Abdominis Plane Block
  description: The investigator will perform oblique subcostal transversus abdominis plane block to that patient group for postoperative analgesia
  arm group label: Group OSTAP
  intervention type: Procedure
  intervention name: Transmuscular Quadratus Lumborum Block
  description: The investigator will perform transmuscular quadratus lumborum block to that patient group for postoperative analgesia
  arm group label: Group TQLB
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Uludag University
  investigator full name: Kübra Cebeci
  investigator title: Research Assistant
  mesh term: Pain, Postoperative