<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/NCT03790007</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN....</org_study_id>
    <nct_id>NCT03790007</nct_id>
  </id_info>
  <brief_title>COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS</brief_title>
  <official_title>COMPARISON OF INTRAOPERATIVE TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHESIA APPLICATION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatih Sultan Mehmet 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>
      Since 1987, laparoscopic cholecystectomy has become the standard procedure for gallbladder&#xD;
      stones and lesions. Complications due to improvements in laparoscopy and increased surgical&#xD;
      experience have decreased day by day, but there is still a problem in terms of postoperative&#xD;
      pain management. Several pain management procedures have been tried to combat pain after&#xD;
      laparoscopic cholecystectomy. The aim of this study is to decrease the length of hospital&#xD;
      stay, to increase the comfort of the patient and to reduce the cost of treatment. Local&#xD;
      anesthetic injection to port locations, intraperitoneal periportal local anesthetic injection&#xD;
      ,Transversus Abdominis Plane Blok and without any local anesthetic application to the control&#xD;
      group compared to the group's analgesic efficiency and to reduce the amount of analgesics&#xD;
      needed, shorten the length of hospital stay and improve patient comfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic cholecystectomy procedure will be performed in patients older than 18 years of&#xD;
      age for the diagnosis of cholelithiasis. Laparoscopic cholecystectomy procedure will be&#xD;
      performed.4 patients group will be formed Power: 0.80 and alpha: :0.05 The minimum number of&#xD;
      samples determined for each group is n: 34 for each group. It will be determined. In our&#xD;
      clinic, local anesthetic injections are performed routinely to the trocar areas in&#xD;
      laparoscopic cholecystectomy operations. After endotracheal intubation at the beginning of&#xD;
      the operation, after appropriate skin staining and sterile dressing, Transversus abdominis&#xD;
      plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis&#xD;
      muscle regions) will be applied. to the second group local anesthetic injection (6 cc to&#xD;
      subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution)&#xD;
      to be applied, in the third group intraperitoneal direct vision of the gallbladder&#xD;
      area-periportal area under the direct injection of local anesthetic spraying process&#xD;
      (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc saline, 20 cc&#xD;
      0.5% bupivacaine solution total 40 cc spraying will be applied. The fourth group will be the&#xD;
      control group and any of these methods will not be applied, the operation time and&#xD;
      peroperative complications (pouch perforation etc.) will be recorded. Paracetamol 1 g + 1 mg&#xD;
      / kg tramadol IV will be applied to all four groups as standard before extubation. Visual&#xD;
      analogue scale (VAS) will be applied to all patients in the postoperative period. If VAS&gt; 3&#xD;
      is still present, a dose of 1 mg / kg tramadol will be administered. Tenoxicam 1x1 IV will be&#xD;
      applied to the patients on the 12th hour. All patients were postoperative; 1,2,4,6,12,24. VAS&#xD;
      scores , patient satisfaction (0: never satisfied, 5: very satisfied) will be recorded. The&#xD;
      group of patients will be determined according to the order of surgery. Pain scores of the&#xD;
      patients will be performed by a physician who is not in the operation who does not know which&#xD;
      group is taken. The patients included in the group will not be known to the patient by the&#xD;
      pain scoring system and the study will be done as double blind. Patients will be randomized&#xD;
      with this method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>3 types of local anesthetic applying method will be compared</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of postoperative pain: visual analogue scale</measure>
    <time_frame>24 hours</time_frame>
    <description>the level of the pain will be assessed using the VAS ( visual analogue scale) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) that best reflects the intensity of their pain. The pain measurements will be done at 1,2,4,6,12,24 hours. Test is easy to obtain, reliable, valid and can detect changes of over time</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TROCHAR SITES LOCAL ANESTHETIC INJECTION</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intraperitoneal direct vision of the gallbladder excision area-periportal area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc SF, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>group will be the control group and any of these methods will not be applied,</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>In our study this local anesthetic agent will be applied for postoperative pain relief</description>
    <arm_group_label>INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD</arm_group_label>
    <arm_group_label>TROCHAR SITES LOCAL ANESTHETIC INJECTION</arm_group_label>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <other_name>marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age who were admitted to the general surgery department with&#xD;
             the diagnosis of cholelithiasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who need to undergo peroperative open cholecystectomy procedure.&#xD;
&#xD;
          -  Patients with local anesthetic or NSAID allergy&#xD;
&#xD;
          -  Patients in pregnancy&#xD;
&#xD;
          -  Patients who are breastfeeding&#xD;
&#xD;
          -  Patients with connective tissue disease&#xD;
&#xD;
          -  Patients with malignancy in postoperative gallbladder pathological examination and&#xD;
             patients with any malignancy diagnosis&#xD;
&#xD;
          -  Patients with renal impairment, where the effect of using Marcain is unknown&#xD;
&#xD;
          -  Cardiac disease&#xD;
&#xD;
          -  Patients with hepatic impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fatih Sultan Mehmet Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34734</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fatih Sultan Mehmet Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ANIL ERGIN</investigator_full_name>
    <investigator_title>asistant doctor</investigator_title>
  </responsible_party>
  <keyword>laparoscopic cholecystectomy</keyword>
  <keyword>postoperative pain relief</keyword>
  <keyword>local anesthetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_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/NCT03790007
org study id: ANIL ERGIN....
nct id: NCT03790007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since 1987, laparoscopic cholecystectomy has become the standard procedure for gallbladder
      stones and lesions. Complications due to improvements in laparoscopy and increased surgical
      experience have decreased day by day, but there is still a problem in terms of postoperative
      pain management. Several pain management procedures have been tried to combat pain after
      laparoscopic cholecystectomy. The aim of this study is to decrease the length of hospital
      stay, to increase the comfort of the patient and to reduce the cost of treatment. Local
      anesthetic injection to port locations, intraperitoneal periportal local anesthetic injection
      ,Transversus Abdominis Plane Blok and without any local anesthetic application to the control
      group compared to the group's analgesic efficiency and to reduce the amount of analgesics
      needed, shorten the length of hospital stay and improve patient comfort.
Laparoscopic cholecystectomy procedure will be performed in patients older than 18 years of
      age for the diagnosis of cholelithiasis. Laparoscopic cholecystectomy procedure will be
      performed.4 patients group will be formed Power: 0.80 and alpha: :0.05 The minimum number of
      samples determined for each group is n: 34 for each group. It will be determined. In our
      clinic, local anesthetic injections are performed routinely to the trocar areas in
      laparoscopic cholecystectomy operations. After endotracheal intubation at the beginning of
      the operation, after appropriate skin staining and sterile dressing, Transversus abdominis
      plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis
      muscle regions) will be applied. to the second group local anesthetic injection (6 cc to
      subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution)
      to be applied, in the third group intraperitoneal direct vision of the gallbladder
      area-periportal area under the direct injection of local anesthetic spraying process
      (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc saline, 20 cc
      0.5% bupivacaine solution total 40 cc spraying will be applied. The fourth group will be the
      control group and any of these methods will not be applied, the operation time and
      peroperative complications (pouch perforation etc.) will be recorded. Paracetamol 1 g + 1 mg
      / kg tramadol IV will be applied to all four groups as standard before extubation. Visual
      analogue scale (VAS) will be applied to all patients in the postoperative period. If VAS> 3
      is still present, a dose of 1 mg / kg tramadol will be administered. Tenoxicam 1x1 IV will be
      applied to the patients on the 12th hour. All patients were postoperative; 1,2,4,6,12,24. VAS
      scores , patient satisfaction (0: never satisfied, 5: very satisfied) will be recorded. The
      group of patients will be determined according to the order of surgery. Pain scores of the
      patients will be performed by a physician who is not in the operation who does not know which
      group is taken. The patients included in the group will not be known to the patient by the
      pain scoring system and the study will be done as double blind. Patients will be randomized
      with this method.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 3 types of local anesthetic applying method will be compared
primary purpose: Supportive Care
masking: None (Open Label)
measure: Level of postoperative pain: visual analogue scale
time frame: 24 hours
description: the level of the pain will be assessed using the VAS ( visual analogue scale) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) that best reflects the intensity of their pain. The pain measurements will be done at 1,2,4,6,12,24 hours. Test is easy to obtain, reliable, valid and can detect changes of over time
arm group label: Transversus Abdominis Plane Block
arm group type: Active Comparator
description: Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left transversus abdominis muscle regions) will be applied.
arm group label: TROCHAR SITES LOCAL ANESTHETIC INJECTION
arm group type: Active Comparator
description: local anesthetic injection (6 cc to subxiphoid and infraumbilical trocar sites, 4 cc instead of 2 cc, 0.5% bupivacaine solution to be applied)
arm group label: INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD
arm group type: Active Comparator
description: Intraperitoneal direct vision of the gallbladder excision area-periportal area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periportal area 1: 1 diluted with 20 cc SF, 20 cc 0.5% bupivacaine solution total 40 cc spraying will be applied.
arm group label: CONTROL GROUP
arm group type: No Intervention
description: group will be the control group and any of these methods will not be applied,
intervention type: Drug
intervention name: Bupivacaine
description: In our study this local anesthetic agent will be applied for postoperative pain relief
arm group label: INTRAPERİTONEAL LOCAL ANESTHETIC SPREADING METHOD
arm group label: TROCHAR SITES LOCAL ANESTHETIC INJECTION
arm group label: Transversus Abdominis Plane Block
other name: marcaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Fatih Sultan Mehmet Training and Research Hospital
investigator full name: ANIL ERGIN
investigator title: asistant doctor
mesh term: Pain, Postoperative
mesh term: Bupivacaine
sharing ipd: No