<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/NCT04474873</url>
  </required_header>
  <id_info>
    <org_study_id>E1-20-315</org_study_id>
    <nct_id>NCT04474873</nct_id>
  </id_info>
  <brief_title>Effectivenes of Erector Spinae Plane Block in Percutaneous Nephrolithotomy?</brief_title>
  <official_title>SHOULD THE ERECTOR SPİNAE PLANE BLOCK BE APPLIED IN THE PAIN MANAGEMENT OF PERCUTANOUS NEPHROLITOTOMY SURGERY?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara City Hospital Bilkent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ankara City Hospital Bilkent</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 investigates the effectiveness of the erector spinae plane block (ESPB) in pain&#xD;
      management of patients undergoing PNL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes&#xD;
      severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and&#xD;
      peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral&#xD;
      and intravenous treatments. The primary aim of our study is to investigate the effectiveness&#xD;
      of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.&#xD;
&#xD;
      Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial&#xD;
      peak expiratory flow measurements, postoperative agitation score of the patient (Riker&#xD;
      Score), ambulation time, length of hospital stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2020</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dynamic Visual Analog Scale</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Expiratory Flow Rate( PEFR)</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>maximum speed of expiration as measured with a peak flow meter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for first analgesic requirement</measure>
    <time_frame>24 hours</time_frame>
    <description>Time between end of surgery and patients first analgesic demand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ambulation time</measure>
    <time_frame>5 days</time_frame>
    <description>first postoperative mobilization time of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>1 week</time_frame>
    <description>day of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rikert Agitation Scale</measure>
    <time_frame>24 hours</time_frame>
    <description>postoperative agitation score&#xD;
unarousable&#xD;
very sedated&#xD;
sedated&#xD;
calm and cooperative&#xD;
agitated&#xD;
very agitated&#xD;
dangerous agitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea and vomiting</measure>
    <time_frame>24 hours</time_frame>
    <description>incidence of nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction with anesthesia and analgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>starting oral intake</measure>
    <time_frame>48 hours</time_frame>
    <description>first oral intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary catheter releated pain score(Visual Analog Scale)</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgeon satisfaction with anesthesia and analgesia</measure>
    <time_frame>24 hour</time_frame>
    <description>4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Nephrolithotomy, Percutaneous</condition>
  <condition>Erector Spinae Plane Block</condition>
  <arm_group>
    <arm_group_label>Group 1:Conventional intravenous analgesia</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional intravenous analgesia applied according to surgeon's preference</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2:ESPB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>erector spinae block</intervention_name>
    <description>we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.</description>
    <arm_group_label>Group 2:ESPB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing PNL between 18-65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serious cardiac, respiratory, hepatic, renal or haemotologic disease&#xD;
&#xD;
          -  mental disorder and hearing problem&#xD;
&#xD;
          -  anxiety, depression and / or other psychiatric disorders&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  refusal of patient&#xD;
&#xD;
          -  Allergy or contraindications to drugs used in the study&#xD;
&#xD;
          -  ASA &gt; 2 Inflammation or infection over injection site Obese patients BMI ≥35/&#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>Semih Baskan, 2</last_name>
    <role>Study Director</role>
    <affiliation>Ankara City Hospital Anesthesiology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara City Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.</citation>
    <PMID>31620856</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara City Hospital Bilkent</investigator_affiliation>
    <investigator_full_name>semih başkan</investigator_full_name>
    <investigator_title>assistant professor</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04474873
org study id: E1-20-315
nct id: NCT04474873
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the effectiveness of the erector spinae plane block (ESPB) in pain
      management of patients undergoing PNL.
Although percutaneous nephrolithotomy(PNL) is a minimally invasive procedure, it causes
      severe postoperative pain due to dilatation of the renal capsule and parenchymal duct and
      peritubal distension of the nephrostomy tube. PNL-related pain has a limited response to oral
      and intravenous treatments. The primary aim of our study is to investigate the effectiveness
      of the erector spinae plane block (ESPB) in pain management of patients undergoing PNL.

      Our secondary aim is determining if any possible clinical effect of ESPB in terms of serial
      peak expiratory flow measurements, postoperative agitation score of the patient (Riker
      Score), ambulation time, length of hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Visual Analog Scale
time frame: postoperative 24 hours
description: the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
measure: Dynamic Visual Analog Scale
time frame: postoperative 24 hours
description: the amount of pain during mobilization, deep breathing or coughing that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart
measure: Peak Expiratory Flow Rate( PEFR)
time frame: postoperative 24 hours
description: maximum speed of expiration as measured with a peak flow meter
measure: Time for first analgesic requirement
time frame: 24 hours
description: Time between end of surgery and patients first analgesic demand
measure: ambulation time
time frame: 5 days
description: first postoperative mobilization time of the patient
measure: length of hospital stay
time frame: 1 week
description: day of hospitalization
measure: Rikert Agitation Scale
time frame: 24 hours
description: postoperative agitation score
unarousable
very sedated
sedated
calm and cooperative
agitated
very agitated
dangerous agitation
measure: nausea and vomiting
time frame: 24 hours
description: incidence of nausea and vomiting
measure: patient satisfaction with anesthesia and analgesia
time frame: 24 hour
description: 4 Likert scale ( the level of satisfaction of a patient ranges from satisfied (1) to nonsatisfied(4)
measure: starting oral intake
time frame: 48 hours
description: first oral intake
measure: urinary catheter releated pain score(Visual Analog Scale)
time frame: postoperative 24 hours
description: the amount of pain that a patient feels ranges across a continuum from none(0) to an extreme amount of pain(10) on a chart.
measure: surgeon satisfaction with anesthesia and analgesia
time frame: 24 hour
description: 4 Likert scale ( the level of satisfaction of surgeon ranges from satisfied (1) to nonsatisfied(4)
arm group label: Group 1:Conventional intravenous analgesia
arm group type: No Intervention
description: Conventional intravenous analgesia applied according to surgeon's preference
arm group label: Group 2:ESPB
arm group type: Active Comparator
description: A 6-13 MHz linear probe was used for ultrasound-guided ESPB (Logiq e, General Electric, USA,) performed at the T11 level. The transverse process was detected by sliding the transducer 3-4 cm laterally from the midline, and after identification of the transverse process, a 20-gauge 100mm insulated echogenic needle (Vygon locoplex, France) was used
intervention type: Procedure
intervention name: erector spinae block
description: we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.
arm group label: Group 2:ESPB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Semih Baskan, 2
role: Study Director
affiliation: Ankara City Hospital Anesthesiology Department
facility: 
country: Turkey
citation: Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.
PMID: 31620856
responsible party type: Principal Investigator
investigator affiliation: Ankara City Hospital Bilkent
investigator full name: semih başkan
investigator title: assistant professor
mesh term: Pain, Postoperative
sharing ipd: No