<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/NCT03793764</url>
  </required_header>
  <id_info>
    <org_study_id>2018/15/21</org_study_id>
    <nct_id>NCT03793764</nct_id>
  </id_info>
  <brief_title>Comparison of TAP Bock vs QL Block in Varicocele Surgery</brief_title>
  <official_title>The Comparison of TAP Block and QL Block on Postoperative Analgesic Consumption and Patient Satisfaction After Varicocele Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ömer Faruk Boran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam 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>
      In this study we aim to compare the effect of TAP block and QL block on postoperative&#xD;
      analgesia, analgesic consumption , side effects and patient satisfaction after varicocelec&#xD;
      surgery.&#xD;
&#xD;
      75 patients will be randomized into 3 groups:TAP Group (Group T) n = 25, QL Group (Group Q) n&#xD;
      = 25, Control Group (Group K) n = 25 All patients will be operated on with spinal anesthesia.&#xD;
      TAP and QL blocks will be performed after completion of the surgeries. In the postoperative&#xD;
      care unit, an iv patient-controlled analgesia protocol with tramadol will be started.&#xD;
      Patients in all three groups will be assessed with a resting and cough VAS (visual analog&#xD;
      scale) at postoperative 2,4,6,12,18 and 24 hours and values will be recorded. The amount of&#xD;
      analgesic consumption and the first analgesic request times will be recorded. Post-operative&#xD;
      QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied,&#xD;
      side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient&#xD;
      satisfaction will be assessed with these methods as bad, medium, good, and very good.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:TAP is the application of local anesthetic agents to block the anterior neck of the&#xD;
      thoracic intercostal (T7-T12) and first lumbar (L1) nerves in the anatomic neurofascial gap&#xD;
      between the internal oblique and transversus abdominis muscle located in the anterolateral&#xD;
      region of the abdomen. It was first described by Rafi in 2001. Then in 2007 Hebbart et al.&#xD;
      described that using USG, TAP block could be implemented more effectively and safely. With QL&#xD;
      block, a local anesthetic agent is applied to the posterior layer of the thoracolumbar fascia&#xD;
      and similar nerve blockage is achieved. The technique was first described by Blanco in 2007.&#xD;
      TAP block and QL block may be a good method for postoperative pain control. We aimed to&#xD;
      compare the efficacy of TAP block and QL block to analgesic consumption after varicocelectomy&#xD;
      operations, analgesic side effects and analgesia quality and to compare these two block&#xD;
      efficacy.&#xD;
&#xD;
      Material &amp; Method:75 patients in the ASA I-II risk group, aged 18-45 years, who will undergo&#xD;
      elective varicocelectomy surgery, will be randomized using the cohort procedure. The patient&#xD;
      will be informed about the study and will be included in the study after the patient is&#xD;
      approved with the approval form. The three groups will be divided into TAP Group (Group T) n&#xD;
      = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25. A total of 75 patients were&#xD;
      planned to receive α = 0,05 at the β: 0.20 level and 0.80 at the power level and n = 25 for&#xD;
      each group. Reference work including VAS scores and I-TAP method was taken into consideration&#xD;
      when the sample size of the study was determined. The normal distribution of data in the&#xD;
      statistical evaluation of the study will be examined by the Shapiro-Wilk test. One-way ANOVA&#xD;
      will be performed for comparison of groups (if the data are normally distributed). Multiple&#xD;
      comparisons Tukey test, Dunnett test Tamhane T2 test will be applied. (Kruskal-Wallis H test&#xD;
      will be applied in cases where it does not normally disperse.) Multiple comparison will be&#xD;
      performed with the Dunn-Sidak test. Statistical significance is accepted as p &lt;0.05, data&#xD;
      will be examined in the IBMSPSS program. All three patients will be operated on with spinal&#xD;
      anesthesia. Patients with coagulopathy who are contraindicated for spinal anesthesia, known&#xD;
      allergies to the drugs to be used, infected and non-voluntary patients to be excluded from&#xD;
      the study. At the end of the disease operation in Group T, after the necessary antiseptic&#xD;
      conditions are established in the supine position, the USG probe midpoint (within the petit&#xD;
      triangle). After the abdominal muscle layers are seen, the facial muscle sensation is taken&#xD;
      when the needle-like muscular layers and facial muscles pass, and the needle is controlled&#xD;
      with USG. After receiving the second click feeling (passage of the internalocutaneous&#xD;
      fascia), the needle-like localization will be determined by applying a test dose of 0.5-1 ml.&#xD;
      After localization is confirmed, frequent aspiration and local anesthetic agent will be given&#xD;
      to the neurophysiologic plan and TAP block will be applied. To apply the lateral QL block to&#xD;
      the patient in Group Q, a low frequency convex probe is inserted into the patient while the&#xD;
      patient is in the supine position. Quadratus lumborum block 1 is injected with 20 mL of local&#xD;
      anesthetic on the lateral side of the QL muscle in the area where the transversus abdominis&#xD;
      muscle contacts the transversal fascia at the level that enters the aponeurope. Local&#xD;
      analgesics will not be administered with Group III disease needle. When the patient is&#xD;
      removed to the postoperative care unit, an iv patient-controlled analgesia device will be&#xD;
      applied. Patients in all three groups will be assessed with a resting and cough VAS (visual&#xD;
      analog scale) at postoperative 2,4,6,12,18 and 24 hours (pain intensity: 0 no pain and 10:&#xD;
      the most severe pain I have ever heard) and values will be recorded. When the patient has a&#xD;
      pain, an analgesic agent will be given according to the patient-controlled analgesia&#xD;
      protocol. The amount of analgesic agent consumed by the patients when the first analgesic&#xD;
      agent is needed and 24 hours will be recorded. Post-operative QUIPS: Quality Improvement in&#xD;
      Postoperative Pain Management questionnaire will be applied, side effects such as&#xD;
      nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed&#xD;
      with these methods as bad, medium, good, and very good.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 25, 2018</start_date>
  <completion_date type="Anticipated">June 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2020</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>
    <intervention_model_description>Patients undergoing varicocele surgery under spinal anesthesia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative analgesic consumption</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfacion</measure>
    <time_frame>postoperative 24 hours</time_frame>
    <description>Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Group T</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Q</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this group no intervention will be performed after the end of operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP block</intervention_name>
    <description>USG guided TAP block</description>
    <arm_group_label>Group T</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>QL block</intervention_name>
    <description>USG guided QL block</description>
    <arm_group_label>Group Q</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
          -  Patients undergoing varicocele surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Coagulation abnormality.&#xD;
&#xD;
          -  contraindication for spinal anesthesia&#xD;
&#xD;
          -  Failed block&#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 F Boran</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bay</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ömer F Boran</last_name>
    <phone>03442803796</phone>
    <email>omerfarukboran@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kahramanmaras Sutcu Imam University</name>
      <address>
        <city>Kahramanmaras</city>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ömer Faruk Boran</last_name>
      <phone>+903442803434</phone>
      <phone_ext>3796</phone_ext>
      <email>omerfarukboran@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Ömer Faruk Boran</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kahramanmaraş Sütçü Imam Üniversity</name>
      <address>
        <city>Kahramanmaras</city>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ömer Faruk Boran</last_name>
      <phone>3442803796</phone>
      <phone_ext>3796</phone_ext>
      <email>omerfarukboran@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Varicocele</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/NCT03793764
org study id: 2018/15/21
nct id: NCT03793764
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study we aim to compare the effect of TAP block and QL block on postoperative
      analgesia, analgesic consumption , side effects and patient satisfaction after varicocelec
      surgery.

      75 patients will be randomized into 3 groups:TAP Group (Group T) n = 25, QL Group (Group Q) n
      = 25, Control Group (Group K) n = 25 All patients will be operated on with spinal anesthesia.
      TAP and QL blocks will be performed after completion of the surgeries. In the postoperative
      care unit, an iv patient-controlled analgesia protocol with tramadol will be started.
      Patients in all three groups will be assessed with a resting and cough VAS (visual analog
      scale) at postoperative 2,4,6,12,18 and 24 hours and values will be recorded. The amount of
      analgesic consumption and the first analgesic request times will be recorded. Post-operative
      QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied,
      side effects such as nausea-vomiting, drowsiness will be noted. In addition, patient
      satisfaction will be assessed with these methods as bad, medium, good, and very good.
Purpose:TAP is the application of local anesthetic agents to block the anterior neck of the
      thoracic intercostal (T7-T12) and first lumbar (L1) nerves in the anatomic neurofascial gap
      between the internal oblique and transversus abdominis muscle located in the anterolateral
      region of the abdomen. It was first described by Rafi in 2001. Then in 2007 Hebbart et al.
      described that using USG, TAP block could be implemented more effectively and safely. With QL
      block, a local anesthetic agent is applied to the posterior layer of the thoracolumbar fascia
      and similar nerve blockage is achieved. The technique was first described by Blanco in 2007.
      TAP block and QL block may be a good method for postoperative pain control. We aimed to
      compare the efficacy of TAP block and QL block to analgesic consumption after varicocelectomy
      operations, analgesic side effects and analgesia quality and to compare these two block
      efficacy.

      Material & Method:75 patients in the ASA I-II risk group, aged 18-45 years, who will undergo
      elective varicocelectomy surgery, will be randomized using the cohort procedure. The patient
      will be informed about the study and will be included in the study after the patient is
      approved with the approval form. The three groups will be divided into TAP Group (Group T) n
      = 25, QL Group (Group Q) n = 25, Control Group (Group K) n = 25. A total of 75 patients were
      planned to receive α = 0,05 at the β: 0.20 level and 0.80 at the power level and n = 25 for
      each group. Reference work including VAS scores and I-TAP method was taken into consideration
      when the sample size of the study was determined. The normal distribution of data in the
      statistical evaluation of the study will be examined by the Shapiro-Wilk test. One-way ANOVA
      will be performed for comparison of groups (if the data are normally distributed). Multiple
      comparisons Tukey test, Dunnett test Tamhane T2 test will be applied. (Kruskal-Wallis H test
      will be applied in cases where it does not normally disperse.) Multiple comparison will be
      performed with the Dunn-Sidak test. Statistical significance is accepted as p <0.05, data
      will be examined in the IBMSPSS program. All three patients will be operated on with spinal
      anesthesia. Patients with coagulopathy who are contraindicated for spinal anesthesia, known
      allergies to the drugs to be used, infected and non-voluntary patients to be excluded from
      the study. At the end of the disease operation in Group T, after the necessary antiseptic
      conditions are established in the supine position, the USG probe midpoint (within the petit
      triangle). After the abdominal muscle layers are seen, the facial muscle sensation is taken
      when the needle-like muscular layers and facial muscles pass, and the needle is controlled
      with USG. After receiving the second click feeling (passage of the internalocutaneous
      fascia), the needle-like localization will be determined by applying a test dose of 0.5-1 ml.
      After localization is confirmed, frequent aspiration and local anesthetic agent will be given
      to the neurophysiologic plan and TAP block will be applied. To apply the lateral QL block to
      the patient in Group Q, a low frequency convex probe is inserted into the patient while the
      patient is in the supine position. Quadratus lumborum block 1 is injected with 20 mL of local
      anesthetic on the lateral side of the QL muscle in the area where the transversus abdominis
      muscle contacts the transversal fascia at the level that enters the aponeurope. Local
      analgesics will not be administered with Group III disease needle. When the patient is
      removed to the postoperative care unit, an iv patient-controlled analgesia device will be
      applied. Patients in all three groups will be assessed with a resting and cough VAS (visual
      analog scale) at postoperative 2,4,6,12,18 and 24 hours (pain intensity: 0 no pain and 10:
      the most severe pain I have ever heard) and values will be recorded. When the patient has a
      pain, an analgesic agent will be given according to the patient-controlled analgesia
      protocol. The amount of analgesic agent consumed by the patients when the first analgesic
      agent is needed and 24 hours will be recorded. Post-operative QUIPS: Quality Improvement in
      Postoperative Pain Management questionnaire will be applied, side effects such as
      nausea-vomiting, drowsiness will be noted. In addition, patient satisfaction will be assessed
      with these methods as bad, medium, good, and very good.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients undergoing varicocele surgery under spinal anesthesia
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Postoperative analgesic consumption
time frame: postoperative 24 hours
description: The amount of analgesic agent consumption in the postoperative 24 hours with iv PCA will be recorded.
measure: Patient satisfacion
time frame: postoperative 24 hours
description: Post-operative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be applied, side effects such as nausea-vomiting, drowsiness will be noted. Patient satisfaction will be assessed with these methods as bad, medium, good, and very good.
arm group label: Group T
arm group type: Active Comparator
description: At the end of the surgery USG guided TAP block will be performed with 20 mL of 0.25% isobaric bupivacaine.
arm group label: Group Q
arm group type: Active Comparator
description: At the end of the surgery USG guided QL block will be performed with 20 mL of 0.25% isobaric bupivacaine.
arm group label: Group C
arm group type: No Intervention
description: In this group no intervention will be performed after the end of operation.
intervention type: Procedure
intervention name: TAP block
description: USG guided TAP block
arm group label: Group T
intervention type: Procedure
intervention name: QL block
description: USG guided QL block
arm group label: Group Q
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ömer F Boran
role: Principal Investigator
affiliation: Bay
last name: Ömer F Boran
phone: 03442803796
email: omerfarukboran@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Sponsor-Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Ömer Faruk Boran
investigator title: Assistant Professor
mesh term: Infertility
mesh term: Varicocele
sharing ipd: No