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/NCT06011850</url>
    </required_header>
    <id_info>
      <org_study_id>08.04.2023/484</org_study_id>
      <nct_id>NCT06011850</nct_id>
    </id_info>
    <brief_title>Investigation of the Effects of Quadratus Lumborum Block Applied to Patients in Kidney Transplant Surgery</brief_title>
    <official_title>Comparison of the Effects of Quadratus Lumborum Block (QLB) Applied for Preemptive Analgesia on Post-operative Pain in Recipients and Donors in Renal Transplantation Surgery With Intravenous Analgesic (IVA) Group</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>
        This study aims to determine the most effective and long-lasting pain relief method for&#xD;
        post-operative analgesia in kidney donor and recipient patients in kidney transplantation&#xD;
        programme with the least invasive and least drug administration.&#xD;
  &#xD;
        For this reason, it is planned to perform Quadratus lumborum plane block (QLB) in a group of&#xD;
        patients who will be kidney donors and kidney recipients in kidney transplantation and who&#xD;
        meet the American Society of Anesthesiologists (ASA) Physical Status Classification System&#xD;
        1-3 risk classification between the ages of 18-70 years, and to administer intravenous pain&#xD;
        medication without block in another group. It is planned to include at least 84 patients in&#xD;
        the Quadratus lumborum plan block (QLB) and Intravenous Analgesia group (IVA) without gender&#xD;
        discrimination.&#xD;
  &#xD;
        Postoperative Sedation-Agitation assessment and NRS (numeric pain scale) at 1st hour, 2nd,&#xD;
        6th, 12th and 24th hours, as well as possible side effects such as nausea, vomiting, shoulder&#xD;
        pain, respiratory depression, bradycardia and hypotension, total amount of opioid analgesics&#xD;
        consumed within 24 hours and duration of hospital stay will be observed and recorded.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area&#xD;
  &#xD;
          -  the injection will be administered immediately after general anaesthesia and intubation&#xD;
             of the patient&#xD;
  &#xD;
          -  to monitor compliance with the intervention The medical files and laboratory blood tests&#xD;
             of the patients will be examined to determine whether there are any contraindications to&#xD;
             the intervention (patients will be excluded in case of bleeding diathesis such as&#xD;
             intra-abdominal fluid accumulation, cystic formation, International Normalized Ratio&#xD;
             (INR) &gt; 2 or thrombocytopenia).&#xD;
  &#xD;
        Blood pressure and heart rate values of the patient and the amount of fentanyl consumed will&#xD;
        be recorded throughout the surgery.&#xD;
  &#xD;
        The level of sedation-agitation will be evaluated during extubation at the end of surgery.&#xD;
  &#xD;
        In the postoperative period, blood pressure, heart rate, pain scoring and the amount of&#xD;
        opioid analgesic consumed will be recorded by the anaesthesiologist in the general surgery&#xD;
        organ transplant unit and the general surgery specialist and nurses in the organ transplant&#xD;
        service at the 1st, 2nd, 6th, 12th, and 24th hours.&#xD;
  &#xD;
        The patient's satisfaction level will be evaluated and recorded 24 hours after the operation.&#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 30, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>2 Days</target_duration>
    <primary_outcome>
      <measure>Assessment of pain (NRS) level</measure>
      <time_frame>postoperative 1st, 2nd, 6th, 12th, 24th hours</time_frame>
      <description>The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total postoperative tramadol consumption</measure>
      <time_frame>Within 24 hours postoperatively</time_frame>
      <description>milligrams</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sedation- agitation level</measure>
      <time_frame>Will be assessed from immediately after extubation until transfer from the recovery room to the ward.</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>Duration of first analgesic requirement</measure>
      <time_frame>During the 24 hours postoperative period</time_frame>
      <description>Time in minutes from the patient's extubation to the first analgesic requirement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure measurement</measure>
      <time_frame>It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.</time_frame>
      <description>Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of heart rate</measure>
      <time_frame>It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.</time_frame>
      <description>The number of heart beats per minute 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 during surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction assessment</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>
    <secondary_outcome>
      <measure>Nausea-vomiting</measure>
      <time_frame>During the 24 hours postoperative period</time_frame>
      <description>Questioning about the presence/absence of nausea and/or vomiting in the postoperative period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first</time_frame>
      <description>Days of hospitalisation after the operation</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">84</enrollment>
    <condition>Kidney Transplant Recipient</condition>
    <condition>Kidney Transplant Donor</condition>
    <arm_group>
      <arm_group_label>Kidney Donor QLB Group</arm_group_label>
      <description>Quadratus lumborum block (QLB) will be applied to the kidney donor in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Kidney Donor Paracetamol Group</arm_group_label>
      <description>In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney donor before the surgical incision is started, immediately after induction of general anesthesia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Kidney Recipient QLB Group</arm_group_label>
      <description>Quadratus lumborum block (QLB) will be applied to the kidney recipient in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Kidney Recipient Paracetamol Group</arm_group_label>
      <description>In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney recipient before the surgical incision is started, immediately after induction of general anesthesia.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Being a kidney recipient and donor in an organ transplant program&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18-70 years,&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) Physical Status Classification System&#xD;
               I-III,&#xD;
  &#xD;
            -  Being a volunteer kidney recipient or volunteer donor in a kidney transplant programme&#xD;
               under general anaesthesia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 years or &gt; 70 years&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) Physical Status Classification System &gt;III&#xD;
  &#xD;
            -  body mass index (BMI) &gt; 35 kg/m2&#xD;
  &#xD;
            -  known allergy to local anaesthetics or paracetamol/tramadol&#xD;
  &#xD;
            -  presence of preoperative chronic pain&#xD;
  &#xD;
            -  presence of accumulated fluid or cystic formation in the abdomen&#xD;
  &#xD;
            -  presence of coagulopathy&#xD;
  &#xD;
            -  those who are unable to give written consent&#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_contact>
      <last_name>Fatma Acil, M.D.</last_name>
      <phone>+905337225225</phone>
      <email>acilfatma@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth. 2020 Jul;64(7):605-610. doi: 10.4103/ija.IJA_21_20. Epub 2020 Jul 1.</citation>
      <PMID>32792737</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06011850
  org study id: 08.04.2023/484
  nct id: NCT06011850
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to determine the most effective and long-lasting pain relief method for
        post-operative analgesia in kidney donor and recipient patients in kidney transplantation
        programme with the least invasive and least drug administration.
  
        For this reason, it is planned to perform Quadratus lumborum plane block (QLB) in a group of
        patients who will be kidney donors and kidney recipients in kidney transplantation and who
        meet the American Society of Anesthesiologists (ASA) Physical Status Classification System
        1-3 risk classification between the ages of 18-70 years, and to administer intravenous pain
        medication without block in another group. It is planned to include at least 84 patients in
        the Quadratus lumborum plan block (QLB) and Intravenous Analgesia group (IVA) without gender
        discrimination.
  
        Postoperative Sedation-Agitation assessment and NRS (numeric pain scale) at 1st hour, 2nd,
        6th, 12th and 24th hours, as well as possible side effects such as nausea, vomiting, shoulder
        pain, respiratory depression, bradycardia and hypotension, total amount of opioid analgesics
        consumed within 24 hours and duration of hospital stay will be observed and recorded.
  Plane block ultrasound-guided intra-abdominal injection into the appropriate anatomical area
  
          -  the injection will be administered immediately after general anaesthesia and intubation
             of the patient
  
          -  to monitor compliance with the intervention The medical files and laboratory blood tests
             of the patients will be examined to determine whether there are any contraindications to
             the intervention (patients will be excluded in case of bleeding diathesis such as
             intra-abdominal fluid accumulation, cystic formation, International Normalized Ratio
             (INR) > 2 or thrombocytopenia).
  
        Blood pressure and heart rate values of the patient and the amount of fentanyl consumed will
        be recorded throughout the surgery.
  
        The level of sedation-agitation will be evaluated during extubation at the end of surgery.
  
        In the postoperative period, blood pressure, heart rate, pain scoring and the amount of
        opioid analgesic consumed will be recorded by the anaesthesiologist in the general surgery
        organ transplant unit and the general surgery specialist and nurses in the organ transplant
        service at the 1st, 2nd, 6th, 12th, and 24th hours.
  
        The patient's satisfaction level will be evaluated and recorded 24 hours after the operation.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Assessment of pain (NRS) level
  time frame: postoperative 1st, 2nd, 6th, 12th, 24th hours
  description: The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
  measure: Total postoperative tramadol consumption
  time frame: Within 24 hours postoperatively
  description: milligrams
  measure: Sedation- agitation level
  time frame: Will be assessed from immediately after extubation until transfer from the recovery room to the ward.
  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: Duration of first analgesic requirement
  time frame: During the 24 hours postoperative period
  description: Time in minutes from the patient's extubation to the first analgesic requirement
  measure: Blood pressure measurement
  time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
  description: Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.
  measure: Measurement of heart rate
  time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
  description: The number of heart beats per minute obtained by electrocardiographic monitoring
  measure: Amount of fentanyl consumed during the operation
  time frame: During surgery
  description: Micrograms of fentanyl consumed during surgery
  measure: Patient satisfaction assessment
  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.
  measure: Nausea-vomiting
  time frame: During the 24 hours postoperative period
  description: Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
  measure: Length of hospital stay
  time frame: It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first
  description: Days of hospitalisation after the operation
  arm group label: Kidney Donor QLB Group
  description: Quadratus lumborum block (QLB) will be applied to the kidney donor in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.
  arm group label: Kidney Donor Paracetamol Group
  description: In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney donor before the surgical incision is started, immediately after induction of general anesthesia.
  arm group label: Kidney Recipient QLB Group
  description: Quadratus lumborum block (QLB) will be applied to the kidney recipient in kidney transplant surgery immediately after induction of general anesthesia before the surgical incision is started.
  arm group label: Kidney Recipient Paracetamol Group
  description: In kidney transplantation surgery, 1000 milligrams of Paracetamol will be administered intravenously to the kidney recipient before the surgical incision is started, immediately after induction of general anesthesia.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Fatma Acil, M.D.
  phone: +905337225225
  email: acilfatma@gmail.com
  citation: Sindwani G, Sahu S, Suri A, Sureka S, Thomas M. Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study. Indian J Anaesth. 2020 Jul;64(7):605-610. doi: 10.4103/ija.IJA_21_20. Epub 2020 Jul 1.
  PMID: 32792737
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Fatma Acil
  investigator title: Principal Investigator
  sharing ipd: Undecided