<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/NCT03751540</url>
  </required_header>
  <id_info>
    <org_study_id>Blocks in LC</org_study_id>
    <nct_id>NCT03751540</nct_id>
  </id_info>
  <brief_title>Retrospective Evaluation of Plane Blocks in Laparoscopic Cholecystectomy</brief_title>
  <official_title>Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block Versus Serratus Intercostal Plane Block Plus Rectus Sheath Block; in Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maltepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maltepe 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 investigators use usually a plane block for postoperative analgesia; if it suitable. İn&#xD;
      laparoscopic patients; investigators used oblique subcostal transversus abdominis plane&#xD;
      block; formerly. But in the last few months, the investigators have performed serratus&#xD;
      intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective&#xD;
      evaluation, the aim of the retrospective evaluation is to determine the effects of two block&#xD;
      on postoperative opioid consumption.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>opioid consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessed by NRS</measure>
    <time_frame>24 hours</time_frame>
    <description>Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 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>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>OSTAP</arm_group_label>
    <description>Data of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SIPB plus rectus sheath block</arm_group_label>
    <description>Data of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ostap</intervention_name>
    <description>this block is performed under general anesthesia in this patients for postoperative analgesia.</description>
    <arm_group_label>OSTAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SIPB plus rectus sheath block</intervention_name>
    <description>this block is performed under general anesthesia in this patients for postoperative analgesia.</description>
    <arm_group_label>SIPB plus rectus sheath block</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients undergoing laparoscopic cholecystectomy, ASA I-II-III patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoed laparoscopic cholecystectomy ASA I-II-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients used another block or block combination&#xD;
&#xD;
          -  no block performed patients&#xD;
&#xD;
          -  procedure converted to open procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>serkan tulgar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maltepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maltepe University faculty of medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.</citation>
    <PMID>29278604</PMID>
  </reference>
  <reference>
    <citation>Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.</citation>
    <PMID>29789137</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maltepe University</investigator_affiliation>
    <investigator_full_name>Asst. Prof. Serkan Tulgar, M.D.</investigator_full_name>
    <investigator_title>associated 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/NCT03751540
org study id: Blocks in LC
nct id: NCT03751540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
the investigators use usually a plane block for postoperative analgesia; if it suitable. İn
      laparoscopic patients; investigators used oblique subcostal transversus abdominis plane
      block; formerly. But in the last few months, the investigators have performed serratus
      intercostal (BRILMA) block with bilateral rectus sheath block. in this retrospective
      evaluation, the aim of the retrospective evaluation is to determine the effects of two block
      on postoperative opioid consumption.
observational model: Case-Control
time perspective: Retrospective
measure: opioid consumption
time frame: 24 hours
description: Tramadol consumption in Patient Controlled Analgesia device and additional and rescue analgesic using
measure: Pain assessed by NRS
time frame: 24 hours
description: Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. 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").
arm group label: OSTAP
description: Data of patients (performed oblique subcostal transversus abdominis plane-OSTAP- block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.
arm group label: SIPB plus rectus sheath block
description: Data of patients (performed serratus intercostal plane block-SIPB- plus rectus sheath block for postoperative analgesia in laparoscopic cholecystectomy) will be collected.
intervention type: Procedure
intervention name: ostap
description: this block is performed under general anesthesia in this patients for postoperative analgesia.
arm group label: OSTAP
intervention type: Procedure
intervention name: SIPB plus rectus sheath block
description: this block is performed under general anesthesia in this patients for postoperative analgesia.
arm group label: SIPB plus rectus sheath block
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: serkan tulgar
role: Principal Investigator
affiliation: Maltepe University
facility: 
country: Turkey
citation: Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.
PMID: 29278604
citation: Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
PMID: 29789137
responsible party type: Principal Investigator
investigator affiliation: Maltepe University
investigator full name: Asst. Prof. Serkan Tulgar, M.D.
investigator title: associated professor
mesh term: Pain, Postoperative
sharing ipd: No