<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/NCT03790020</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN.....</org_study_id>
    <nct_id>NCT03790020</nct_id>
  </id_info>
  <brief_title>COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHETIC INJECTION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHESIA APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN PATIENTS WITH LAPAROSCOPIC APPENDECTOMY</brief_title>
  <acronym>APPENDECTOMY</acronym>
  <official_title>COMPARISON OF TRANSVERSUS ABDOMINIS PLANE BLOCK, LOCAL ANESTHETIC INJECTION TO THE PORT SITES AND INTRAPERITONEAL LOCAL ANESTHESIA APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN PATIENTS WITH LAPAROSCOPIC APPENDECTOMY</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>
      The most important determinant of the recovery in abdominal surgery is postoperative pain.&#xD;
      Postoperative pain can be explained by 2 pathways connected to the peritoneum; The first is&#xD;
      the parietal peritoneum, whose innervation is very rich and the other is the visceral&#xD;
      peritoneum which is stimulated at the vagus level. Since 1950, they have been injecting local&#xD;
      anesthetic for post-surgery pain. inflammation and peritoneal irritation are the most&#xD;
      important factors of pain when acute appendicitis is diagnosed. . This increases the length&#xD;
      of hospital stay and increases the cost of pain relief, and reduces patient satisfaction. The&#xD;
      aim of this study is to evaluate the application of Transversus Abdominis Plane Block . local&#xD;
      anesthetic injection to the port sites, intraperitoneal periappendiceal local anesthetic&#xD;
      injection is compared with the control group without any local anesthetic application to&#xD;
      investigate which group has more analgesic effectiveness and thus reduce the amount of&#xD;
      analgesics needed postoperatively, hospitalization Shortening the duration of the patient and&#xD;
      taking the patient comfort to the next level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic Appendectomy procedure will be performed in patients over 18 years of age who&#xD;
      are hospitalized from the emergency department for acute appendicitis. 4 patient group will&#xD;
      be established. The number of samples determined for Power: 0.80 and alpha: 0.05 was&#xD;
      determined as minimum n: 28 for each group. Therefore, the groups will be determined to&#xD;
      include 28 patients. In our clinic, local anesthetic injection to the trocar areas is&#xD;
      routinely performed in laparoscopic appendectomy operations. After endotracheal intubation at&#xD;
      the beginning of the operation, after appropriate skin staining and sterile dressing&#xD;
      Transversus abdominis plane block (10 cc / 10 cc, 0.5% bupivacaine to the right and left&#xD;
      transversus abdominis muscle regions) will be applied. local anesthetic injection to the&#xD;
      pre-incision trocar sites (8 cc instead of infraumbilical trocar, 6 cc instead of the other 2&#xD;
      trocar 20 cc 0.5% bupivacaine solution will be applied), following intraperitoneal direct&#xD;
      visualization of the appendiceal region - local anesthetic spraying into the periappendiceal&#xD;
      area(1: 1 diluted with 20 cc saline, 20 cc 0.5% bupivacaine solution total 40 cc spraying )&#xD;
      will be applied. The fourth group will be the control group and any of these methods will not&#xD;
      be applied, operation time and peroperative complications (appendiceal perforation etc.) will&#xD;
      be recorded.Paracetamol 1 g + 1 mg / kg tramadol IV will be applied to all four groups as&#xD;
      standard before extubation. Visual analogue scale (VAS) will be applied to all patients in&#xD;
      the postoperative period. If VAS&gt; 3 is still present, a dose of 1 mg / kg tramadol will be&#xD;
      administered. Tenoxicam 1x1 IV will be applied to the patients on the 12th hour. All patients&#xD;
      were postoperative; 1,2,4,6,12,24. VAS scores , patient satisfaction (0: never satisfied, 5:&#xD;
      very satisfied) will be recorded. The group of patients will be determined according to the&#xD;
      order of surgery. Pain scores of the patients will be performed by a physician who is not in&#xD;
      the operation who does not know which group is taken. The patients included in the group will&#xD;
      not be known to the patient by the pain scoring system and the study will be done as double&#xD;
      blind. Patients will be randomized 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">November 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>compare of local anesthetic applying methods for postoperative pain relief by VAS (Visual Analog Scala)</measure>
    <time_frame>24 hours</time_frame>
    <description>pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours).&#xD;
(VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.</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 appendix excision area-periappendiciall area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periappendicial 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 older than 18 years of age with acute appendicitis in emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have to undergo peroperative open appendectomy procedure.&#xD;
&#xD;
          -  Patients with local anesthetic or non steroid antiinflammatory allergy&#xD;
&#xD;
          -  Patients in pregnancy&#xD;
&#xD;
          -  Patients with connective tissue disease&#xD;
&#xD;
          -  Patients with malignancy detected in pathological examination of postoperative&#xD;
             appendix and patients with any malignancy diagnosis&#xD;
&#xD;
          -  Perforated patients peroperatively&#xD;
&#xD;
          -  Patients who were evaluated as plastron appendicitis peroperatively&#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>acute appendicitis</keyword>
  <keyword>postoperative pain relief</keyword>
  <keyword>local anesthetic</keyword>
  <keyword>laparoscopic appendectomy</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/NCT03790020
org study id: ANIL ERGIN.....
nct id: NCT03790020
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The most important determinant of the recovery in abdominal surgery is postoperative pain.
      Postoperative pain can be explained by 2 pathways connected to the peritoneum; The first is
      the parietal peritoneum, whose innervation is very rich and the other is the visceral
      peritoneum which is stimulated at the vagus level. Since 1950, they have been injecting local
      anesthetic for post-surgery pain. inflammation and peritoneal irritation are the most
      important factors of pain when acute appendicitis is diagnosed. . This increases the length
      of hospital stay and increases the cost of pain relief, and reduces patient satisfaction. The
      aim of this study is to evaluate the application of Transversus Abdominis Plane Block . local
      anesthetic injection to the port sites, intraperitoneal periappendiceal local anesthetic
      injection is compared with the control group without any local anesthetic application to
      investigate which group has more analgesic effectiveness and thus reduce the amount of
      analgesics needed postoperatively, hospitalization Shortening the duration of the patient and
      taking the patient comfort to the next level.
Laparoscopic Appendectomy procedure will be performed in patients over 18 years of age who
      are hospitalized from the emergency department for acute appendicitis. 4 patient group will
      be established. The number of samples determined for Power: 0.80 and alpha: 0.05 was
      determined as minimum n: 28 for each group. Therefore, the groups will be determined to
      include 28 patients. In our clinic, local anesthetic injection to the trocar areas is
      routinely performed in laparoscopic appendectomy 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. local anesthetic injection to the
      pre-incision trocar sites (8 cc instead of infraumbilical trocar, 6 cc instead of the other 2
      trocar 20 cc 0.5% bupivacaine solution will be applied), following intraperitoneal direct
      visualization of the appendiceal region - local anesthetic spraying into the periappendiceal
      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, operation time and peroperative complications (appendiceal 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: compare of local anesthetic applying methods for postoperative pain relief by VAS (Visual Analog Scala)
time frame: 24 hours
description: pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours).
(VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
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 appendix excision area-periappendiciall area under the direct injection of local anesthetic spraying process (percutaneous method injected into the periappendicial 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