<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/NCT02185716</url>
  </required_header>
  <id_info>
    <org_study_id>2013-414</org_study_id>
    <nct_id>NCT02185716</nct_id>
  </id_info>
  <brief_title>Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery</brief_title>
  <official_title>Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duzce University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duzce University</source>
  <brief_summary>
    <textblock>
      Postoperative pain is a significant cause of increased morbidity in the perioperative period,&#xD;
      leading to patient discomfort and greater hospital length of stay. Laparoscopic&#xD;
      cholecystectomy associated with significant postoperative pain, a substantial component of&#xD;
      which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has&#xD;
      been used for providing pain relief following abdominal surgery. We designed this study with&#xD;
      the hypothesis that, administering TAP block with levobupivacaine in laparoscopic&#xD;
      cholecystectomy provides superior analgesic effects than port-side infiltration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized and double-blind study, 75 patients, American Society of Anesthesiology&#xD;
      (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic&#xD;
      cholecystectomy operation under general anesthesia will be accepted. The patients will be&#xD;
      divided into three groups and they will be given postoperative pain treatment with&#xD;
      patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24,&#xD;
      Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total&#xD;
      analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be&#xD;
      recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12,&#xD;
      16 and 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain scores</measure>
    <time_frame>24 hours</time_frame>
    <description>VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative total analgesic consumption</measure>
    <time_frame>Postoperatively 24 h</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>side effects</measure>
    <time_frame>postoperatively 24 h</time_frame>
    <description>In hours of postoperative 1, 2, 4, 8, 12, 16 and 24 nausea, and vomiting will be recorded.Nausea (0=non-existent, 1=mild, 2 = severe) and vomiting (0=non-existent, 1=mild, 2 = severe) of the patients will be scored postoperatively on a 3-point scale.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Cholecystectomy, Laparoscopic</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>local infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only routine general anesthesia will be applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0.25 %</intervention_name>
    <arm_group_label>TAP</arm_group_label>
    <other_name>chirocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0.5%</intervention_name>
    <arm_group_label>local infiltration</arm_group_label>
    <other_name>chirocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II risk group,&#xD;
&#xD;
          -  between the ages of 20-60,&#xD;
&#xD;
          -  undergo elective laporoscopic cholecystectomy operation under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to anesthetic medication,&#xD;
&#xD;
          -  coronary artery patients,&#xD;
&#xD;
          -  obese patients,&#xD;
&#xD;
          -  emergencies,&#xD;
&#xD;
          -  pregnants,&#xD;
&#xD;
          -  abdomen operation history&#xD;
&#xD;
          -  heart block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gülbin Sezen, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duzce University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duzce University Medical Faculty</name>
      <address>
        <city>Duzce</city>
        <zip>81160</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.</citation>
    <PMID>24348067</PMID>
  </results_reference>
  <results_reference>
    <citation>Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.</citation>
    <PMID>23770342</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Duzce University</investigator_affiliation>
    <investigator_full_name>gulbin sezen</investigator_full_name>
    <investigator_title>assistant of professor</investigator_title>
  </responsible_party>
  <keyword>Transversus abdominis plane block</keyword>
  <keyword>levobupivacaine</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>Levobupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02185716
org study id: 2013-414
nct id: NCT02185716
lead sponsor: 
Postoperative pain is a significant cause of increased morbidity in the perioperative period,
      leading to patient discomfort and greater hospital length of stay. Laparoscopic
      cholecystectomy associated with significant postoperative pain, a substantial component of
      which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has
      been used for providing pain relief following abdominal surgery. We designed this study with
      the hypothesis that, administering TAP block with levobupivacaine in laparoscopic
      cholecystectomy provides superior analgesic effects than port-side infiltration.
In this randomized and double-blind study, 75 patients, American Society of Anesthesiology
      (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic
      cholecystectomy operation under general anesthesia will be accepted. The patients will be
      divided into three groups and they will be given postoperative pain treatment with
      patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24,
      Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total
      analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be
      recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12,
      16 and 24.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: postoperative pain scores
time frame: 24 hours
description: VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,
measure: postoperative total analgesic consumption
time frame: Postoperatively 24 h
measure: side effects
time frame: postoperatively 24 h
description: In hours of postoperative 1, 2, 4, 8, 12, 16 and 24 nausea, and vomiting will be recorded.Nausea (0=non-existent, 1=mild, 2 = severe) and vomiting (0=non-existent, 1=mild, 2 = severe) of the patients will be scored postoperatively on a 3-point scale.
arm group label: local infiltration
arm group type: Active Comparator
description: Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation
arm group label: Control
arm group type: No Intervention
description: Only routine general anesthesia will be applied
arm group label: TAP
arm group type: Experimental
description: Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.
intervention type: Drug
intervention name: Levobupivacaine 0.25 %
arm group label: TAP
other name: chirocaine
intervention type: Drug
intervention name: Levobupivacaine 0.5%
arm group label: local infiltration
other name: chirocaine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gülbin Sezen, MD,PhD
role: Principal Investigator
affiliation: Duzce University
facility: 
country: Turkey
citation: Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.
PMID: 24348067
citation: Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.
PMID: 23770342
responsible party type: Principal Investigator
investigator affiliation: Duzce University
investigator full name: gulbin sezen
investigator title: assistant of professor
mesh term: Pain, Postoperative
mesh term: Levobupivacaine