<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/NCT04406012</url>
  </required_header>
  <id_info>
    <org_study_id>Eskisehir University</org_study_id>
    <secondary_id>Kırıkkale University</secondary_id>
    <nct_id>NCT04406012</nct_id>
  </id_info>
  <brief_title>Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients</brief_title>
  <official_title>Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eskisehir Osmangazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kırıkkale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eskisehir Osmangazi 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>
      The aim of this study is to investigate the analgesic effects of thoracal paravertebral block&#xD;
      in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to&#xD;
      the study group. Conventional analgesia methods were applied to the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization was divided into two groups by using closed envelope method. Postoperative pain&#xD;
      scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain&#xD;
      = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a&#xD;
      deep Breath) were evaluated. Patients with VAS&gt; 4 received additional analgesics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2016</start_date>
  <completion_date type="Actual">July 1, 2016</completion_date>
  <primary_completion_date type="Actual">June 16, 2016</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>Paravertebral block group and Control group</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient VAS scores</measure>
    <time_frame>24 hours</time_frame>
    <description>0=no pain, 10=incredible pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction scores</measure>
    <time_frame>at the end of the 24 hours</time_frame>
    <description>0=not satisfied, 5=very good satisfied</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Pain, Postoperative; Anesthesia, Regional</condition>
  <arm_group>
    <arm_group_label>block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score &gt;4, tramadol 1 mg kg-1 was administered intravenously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paravertebral block</intervention_name>
    <description>paravertebral block group</description>
    <arm_group_label>block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous&#xD;
        nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed&#xD;
        consent was signed by all patients. Patients under 18 years of age, pregnant, with known&#xD;
        hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety&#xD;
        disorder, obesity (BMI&gt; 35kg / m2), history of pneumothorax, phrenic nerve paralysis,&#xD;
        severe aortic stenosis were excluded. Also who did not want to participate the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 26, 2020</last_update_submitted>
  <last_update_submitted_qc>September 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eskisehir Osmangazi University</investigator_affiliation>
    <investigator_full_name>Ferda YAMAN</investigator_full_name>
    <investigator_title>Assist. Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Pain management</keyword>
  <keyword>Analgesia</keyword>
  <keyword>paravertebral block</keyword>
  <keyword>nephrolithotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>when the article published</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/NCT04406012
org study id: Eskisehir University
secondary id: Kırıkkale University
nct id: NCT04406012
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the analgesic effects of thoracal paravertebral block
      in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to
      the study group. Conventional analgesia methods were applied to the control group.
Randomization was divided into two groups by using closed envelope method. Postoperative pain
      scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain
      = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a
      deep Breath) were evaluated. Patients with VAS> 4 received additional analgesics.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Paravertebral block group and Control group
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Patient VAS scores
time frame: 24 hours
description: 0=no pain, 10=incredible pain
measure: Patient Satisfaction scores
time frame: at the end of the 24 hours
description: 0=not satisfied, 5=very good satisfied
arm group label: block group
arm group type: Active Comparator
description: Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist.
arm group label: Control group
arm group type: No Intervention
description: Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score >4, tramadol 1 mg kg-1 was administered intravenously.
intervention type: Procedure
intervention name: paravertebral block
description: paravertebral block group
arm group label: block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Eskisehir Osmangazi University
investigator full name: Ferda YAMAN
investigator title: Assist. Prof. Dr.
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: when the article published