<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/NCT04425447</url>
  </required_header>
  <id_info>
    <org_study_id>33793/4/20</org_study_id>
    <nct_id>NCT04425447</nct_id>
  </id_info>
  <brief_title>Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery</brief_title>
  <official_title>Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block for Anesthesia in Gynecomastia Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The growing increase in the number of gynecomastia surgeries has resulted in an increased&#xD;
      need for anesthetic techniques with improved pain reduction, safety, and fewer complications.&#xD;
&#xD;
      The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial&#xD;
      plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized open label clinical trial will be carried out on 90 male patients&#xD;
      undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      Patients will be randomly allocated into three equal groups by computer generated sequence&#xD;
      through sealed opaque envelopes:&#xD;
&#xD;
      Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.&#xD;
&#xD;
      Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.&#xD;
&#xD;
      Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The amount of intraoperative fentanyl requirement (mg)</measure>
    <time_frame>3 hours</time_frame>
    <description>If the patient complains from pain, fentanyl 25μg intravenously will be administrated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of patient's satisfaction</measure>
    <time_frame>6 hours</time_frame>
    <description>Patient satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Amount of postoperative analgesic requirement (mg)</measure>
    <time_frame>24 hours</time_frame>
    <description>Postoperative pain will be assessed by numeric rating scale (NRS) score and diclofenac sodium 75 mg intramuscular will be given as rescue analgesia if NRS score was &gt;3 (maximum 75 mg/8 hours).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Gynecomastia</condition>
  <condition>Thoracic Interfascial Plane Block</condition>
  <condition>Thoracic Paravertebral Block</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 patients will receive bilateral tumescent local anesthesia as a control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TPVB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 patients will receive bilateral US guided thoracic paravertebral block.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group TIPB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 patients will receive bilateral US guided thoracic interfascial plane block</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tumescent local anesthesia</intervention_name>
    <description>Surgical disinfection of the area will be performed, skin inﬁltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine).&#xD;
Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue.</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thoracic paravertebral block</intervention_name>
    <description>The paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identiﬁed as more squared structure and deeper to the ribs. Once the transverse processes will be identiﬁed, skin inﬁltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4.</description>
    <arm_group_label>Group TPVB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thoracic interfascial plane block</intervention_name>
    <description>Total LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane.&#xD;
In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A</description>
    <arm_group_label>Group TIPB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 18 up to 65 years&#xD;
&#xD;
          -  Male gender only&#xD;
&#xD;
          -  ASA physical status I and II&#xD;
&#xD;
          -  Weight 75-100 kg&#xD;
&#xD;
          -  Duration of surgery ≤ 2 hours&#xD;
&#xD;
          -  Scheduled for elective idiopathic gynecomastia surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Uncooperative patients.&#xD;
&#xD;
          -  Known hypersensitivity to local anesthetic (LA) (bupivacaine).&#xD;
&#xD;
          -  Local infection at the site of injection (TPVB or TIPB).&#xD;
&#xD;
          -  Coagulopathy.&#xD;
&#xD;
          -  History of opioid abuse or chronic analgesic use.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gynecomastia in males only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tanta University Hospitals</name>
      <address>
        <city>Tanta</city>
        <state>ElGharbiaa</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Taysser Mahmoud Abdalraheem</investigator_full_name>
    <investigator_title>Principal Investigator - Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
    <mesh_term>Gynecomastia</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/NCT04425447
org study id: 33793/4/20
nct id: NCT04425447
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The growing increase in the number of gynecomastia surgeries has resulted in an increased
      need for anesthetic techniques with improved pain reduction, safety, and fewer complications.

      The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial
      plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia
      surgery.
This prospective randomized open label clinical trial will be carried out on 90 male patients
      undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.

      Study design:

      Patients will be randomly allocated into three equal groups by computer generated sequence
      through sealed opaque envelopes:

      Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.

      Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.

      Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The amount of intraoperative fentanyl requirement (mg)
time frame: 3 hours
description: If the patient complains from pain, fentanyl 25μg intravenously will be administrated.
measure: Degree of patient's satisfaction
time frame: 6 hours
description: Patient satisfaction before discharge using a 5- point score, with (0 = very dissatisfied, 1 = dissatisfied, 2 = neither satisfied nor dissatisfied, 3 = satisfied and 4 = very satisfied).
measure: Amount of postoperative analgesic requirement (mg)
time frame: 24 hours
description: Postoperative pain will be assessed by numeric rating scale (NRS) score and diclofenac sodium 75 mg intramuscular will be given as rescue analgesia if NRS score was >3 (maximum 75 mg/8 hours).
arm group label: Group C
arm group type: Active Comparator
description: 30 patients will receive bilateral tumescent local anesthesia as a control group
arm group label: Group TPVB
arm group type: Experimental
description: 30 patients will receive bilateral US guided thoracic paravertebral block.
arm group label: Group TIPB
arm group type: Experimental
description: 30 patients will receive bilateral US guided thoracic interfascial plane block
intervention type: Drug
intervention name: Tumescent local anesthesia
description: Surgical disinfection of the area will be performed, skin inﬁltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine).
Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue.
arm group label: Group C
intervention type: Drug
intervention name: Thoracic paravertebral block
description: The paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identiﬁed as more squared structure and deeper to the ribs. Once the transverse processes will be identiﬁed, skin inﬁltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4.
arm group label: Group TPVB
intervention type: Drug
intervention name: Thoracic interfascial plane block
description: Total LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane.
In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A
arm group label: Group TIPB
criteria: 
gender: Male
gender based: Yes
gender description: Gynecomastia in males only
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Taysser Mahmoud Abdalraheem
investigator title: Principal Investigator - Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
mesh term: Aortic Dissection
mesh term: Gynecomastia
mesh term: Anesthetics
sharing ipd: No