<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/NCT02983383</url>
  </required_header>
  <id_info>
    <org_study_id>53</org_study_id>
    <nct_id>NCT02983383</nct_id>
  </id_info>
  <brief_title>Effect of TAP Block for Postoperative Pain Control After Varicocele Operations.</brief_title>
  <official_title>Effect of TAP Block for Postoperative Pain Control After Varicocele Operations on Analgesia Quality and Postoperative Analgesic Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TAP block is the administration of local anesthetic agents into the anatomic neurofascial&#xD;
      cavity between the internal oblique and transversus abdominis muscle in the antero-lateral&#xD;
      region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and&#xD;
      first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We&#xD;
      aim to show the effect of TAP block administration on analgesic consumption after&#xD;
      varicocelectomy operations, side effects linked to analgesic use and analgesic quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing&#xD;
      varicocelectomy operations under elective conditions, randomized with a lottery method.&#xD;
      Patients will be informed of the study and included in the study after giving permission with&#xD;
      a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25)&#xD;
      and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those&#xD;
      with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the&#xD;
      medications used, with infection in the operated area, and those who do not volunteer will be&#xD;
      excluded from the study. At the end of the operation, patients in Group T in the supine&#xD;
      position will have a USI probe placed at the middle point between the costal edge and iliac&#xD;
      crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then&#xD;
      after the abdominal muscle layers are observed, the needle tip will be advanced through the&#xD;
      muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled&#xD;
      fashion. After feeling the second click (passing the internal oblique muscle fascia), a test&#xD;
      dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip.&#xD;
      Then noting the location, with frequent aspiration local anesthetic agent will be&#xD;
      administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant&#xD;
      added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4,&#xD;
      6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain&#xD;
      severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded.&#xD;
      When patients are in pain, analgesic agent will be administered according to patient&#xD;
      controlled analgesia protocol. The time of first requirement for analgesic agent and the&#xD;
      amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like&#xD;
      postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction&#xD;
      will be assessed by asking if the surgical method they experienced was bad, moderate, good or&#xD;
      very good and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 2018</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>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS (visual analog scale)</measure>
    <time_frame>24 Hours</time_frame>
    <description>VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative side effects</measure>
    <time_frame>24 Hours</time_frame>
    <description>questionnaire for postoperative nausea, vomiting, numbness and itching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>24 Hours</time_frame>
    <description>questionnaire for patient satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time to first analgesic</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Varicocele</condition>
  <arm_group>
    <arm_group_label>TAP block group (Group T)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group without TAP (Group P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in Group P will have adjuvant added to spinal anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block group (Group T)</intervention_name>
    <description>At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.</description>
    <arm_group_label>TAP block group (Group T)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).</description>
    <arm_group_label>Group without TAP (Group P)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        18-45 year old ASA I-II patient group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications for spinal anesthesia&#xD;
&#xD;
          2. Coagulopathy&#xD;
&#xD;
          3. Known allergy to medications used&#xD;
&#xD;
          4. Infection in the operated area&#xD;
&#xD;
          5. Non-volunteer patient&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ömer Faruk Boran</last_name>
    <role>Study Chair</role>
    <affiliation>Kahramanmaraş Üniversitesi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kahramanmaras Sutcu Imam University</name>
      <address>
        <city>Kahramanmaras</city>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Ömer Faruk Boran</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Varicocele</keyword>
  <keyword>TAP block</keyword>
  <keyword>spinal anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicocele</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT02983383
org study id: 53
nct id: NCT02983383
lead sponsor: 
has dmc: Yes
TAP block is the administration of local anesthetic agents into the anatomic neurofascial
      cavity between the internal oblique and transversus abdominis muscle in the antero-lateral
      region of the abdomen to block the anterior branches of the thoracic intercostal (T7-T12) and
      first lumbar (L1) nerves. TAP block may be a good method for postoperative pain control. We
      aim to show the effect of TAP block administration on analgesic consumption after
      varicocelectomy operations, side effects linked to analgesic use and analgesic quality.
The study will include 50 patients aged from 18-45 years in ASA I-II risk group undergoing
      varicocelectomy operations under elective conditions, randomized with a lottery method.
      Patients will be informed of the study and included in the study after giving permission with
      a patient consent form. Patients will be divided into two groups; TAP group (Group T, n=25)
      and P (Group P, n=25). Both groups will be taken for operation under spinal anesthesia. Those
      with contraindications for spinal anesthesia, with coagulopathy, with known allergy to the
      medications used, with infection in the operated area, and those who do not volunteer will be
      excluded from the study. At the end of the operation, patients in Group T in the supine
      position will have a USI probe placed at the middle point between the costal edge and iliac
      crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then
      after the abdominal muscle layers are observed, the needle tip will be advanced through the
      muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled
      fashion. After feeling the second click (passing the internal oblique muscle fascia), a test
      dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip.
      Then noting the location, with frequent aspiration local anesthetic agent will be
      administered to the neurofascial plane for TAP block. Patients in Group P will have adjuvant
      added to spinal anesthesia. Patients in both groups will have pain scores assessed at 2, 4,
      6, 12 and 24 hours postoperative at rest and coughing with VAS (visual analog scale) (pain
      severity: 0 no pain to 10 most severe pain experienced to date) and values will be recorded.
      When patients are in pain, analgesic agent will be administered according to patient
      controlled analgesia protocol. The time of first requirement for analgesic agent and the
      amount of analgesic agent used in 24 hours will be recorded for patients. Side effects like
      postoperative nausea, vomiting, or itching will be noted. Additionally, patient satisfaction
      will be assessed by asking if the surgical method they experienced was bad, moderate, good or
      very good and recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
measure: VAS (visual analog scale)
time frame: 24 Hours
description: VAS (visual analog scale) (pain severity: 0 no pain to 10 most severe pain experienced to date) score changes in the postoperative period at rest and coughing
measure: Postoperative side effects
time frame: 24 Hours
description: questionnaire for postoperative nausea, vomiting, numbness and itching
measure: Patient satisfaction
time frame: 24 Hours
description: questionnaire for patient satisfaction
measure: time to first analgesic
time frame: 24 hours
arm group label: TAP block group (Group T)
arm group type: Active Comparator
description: At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
arm group label: Group without TAP (Group P)
arm group type: Active Comparator
description: Patients in Group P will have adjuvant added to spinal anesthesia.
intervention type: Procedure
intervention name: TAP block group (Group T)
description: At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
arm group label: TAP block group (Group T)
intervention type: Procedure
intervention name: spinal anesthesia
description: Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).
arm group label: Group without TAP (Group P)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ömer Faruk Boran
role: Study Chair
affiliation: Kahramanmaraş Üniversitesi
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Ömer Faruk Boran
investigator title: Assistant Professor
mesh term: Varicocele
mesh term: Pain, Postoperative
mesh term: Anesthetics
sharing ipd: No