<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/NCT03769428</url>
  </required_header>
  <id_info>
    <org_study_id>erector-spinae</org_study_id>
    <nct_id>NCT03769428</nct_id>
  </id_info>
  <brief_title>Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block</brief_title>
  <acronym>erectspinae</acronym>
  <official_title>Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block, a Randomized Controlled Double Blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ben marzouk Sofiene</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Tunis El Manar</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>
      Breast cancer surgery is one of the most common surgeries, due to the high incidence of&#xD;
      breast cancer. Unfortunately, patients experience significant postoperative acute pain,&#xD;
      placing them at risk for increased clinical morbidity and the development of disabling&#xD;
      chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by&#xD;
      the patient is one of the best predictors of chronic pain.&#xD;
&#xD;
      However, postoperative analgesia in breast cancer surgery is difficult due to the extensive&#xD;
      nature of the surgery and the complex innervation of the breast.&#xD;
&#xD;
      Several newly described regional anesthesia techniques exist to control perioperative pain,&#xD;
      including the Paravertebral block (PVB) which has been proved to be the most effective one.&#xD;
      The anatomic proximity of the pleura and central neuraxial system makes it a particularly&#xD;
      challenging technique and carrying a risk of pneumothorax.&#xD;
&#xD;
      The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero&#xD;
      et al in September 2016. Local anesthetic injection is performed beneath the erector spinae&#xD;
      muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral&#xD;
      levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal&#xD;
      nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the&#xD;
      context of surgical pain during breast cancer surgery.&#xD;
&#xD;
      There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in&#xD;
      controlling post-operative breast surgery pain.&#xD;
&#xD;
      The main purpose of this study is to evaluate the postoperative analgesic effect of&#xD;
      Ultrasound-guided ESPB in patients undergoing breast cancer surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a prospective double blind trial. Sixty female patient aged between 20-65 years old&#xD;
      with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for&#xD;
      elective surgery for breast cancer were included in the study. Only unilateral surgical&#xD;
      procedures will be included. The patients will be randomized into two groups:&#xD;
&#xD;
      Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction&#xD;
      of general anesthetic.&#xD;
&#xD;
      Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a&#xD;
      placebo injection of normal saline in almost identical fashion to that of the ESP block.&#xD;
&#xD;
      Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the&#xD;
      contralateral upper limb of the surgical site and monitors (pulse oximeter,&#xD;
      electrocardiography, non-invasive blood pressure (NIBP) will be applied.&#xD;
&#xD;
      All blocks will be performed before induction of general anesthesia.&#xD;
&#xD;
      ESPB technique:&#xD;
&#xD;
      The ESPB will be done in the sitting position using linear ultrasound probe (L10) of MySonoU6&#xD;
      machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane&#xD;
      approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal&#xD;
      approach. Three muscles will be identified superficial to the transverse process shadow as&#xD;
      follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected&#xD;
      between the erector spinae muscle and transverse process. Following confirmation of the&#xD;
      correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40&#xD;
      mL of fluid will be injected next. The distribution will be observed in both cranial and&#xD;
      caudal directions.&#xD;
&#xD;
        -  Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine&#xD;
           (3.75mg/cc).&#xD;
&#xD;
        -  Group P (Sham ESP block) will receive 40 cc of normal saline.&#xD;
&#xD;
      General Anesthesia:&#xD;
&#xD;
      All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced&#xD;
      by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia&#xD;
      maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood&#xD;
      Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired&#xD;
      Oxygen.&#xD;
&#xD;
      The reinjection of 0.5μg/kg of fentanyl will be given intraoperatively either when heart rate&#xD;
      or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal&#xD;
      records.&#xD;
&#xD;
      Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for&#xD;
      postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal&#xD;
      extubation will be done once patient fulfilled the extubation criteria. In the recovery room,&#xD;
      all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1&#xD;
      mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1&#xD;
      h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores&#xD;
      ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at&#xD;
      1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the&#xD;
      investigators will resort to rescue analgesia as following: If 6&lt;VAS&lt;8: paracetamol 1g IV&#xD;
      will be administered and if VAS&gt;8: paracetamol 1g IV associated to ketoprofen100mg IM.&#xD;
&#xD;
      Incidence of nausea and vomiting, and total morphine consumption during the 24-h&#xD;
      postoperative period will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Parallel Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparing morphine consumption rates within 24h postoperative</measure>
    <time_frame>The first 24 hours postoperative</time_frame>
    <description>All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of pain in postoperative period via visual analogue scales (VAS) .</measure>
    <time_frame>The first 24 hours postoperative</time_frame>
    <description>Postoperative pain will be assessed using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).The VAS will be recorded at 1,2,4,8 6, 12 ,16,20 and 24 h postoperatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total morphine demand</measure>
    <time_frame>During 24 hours postoperative</time_frame>
    <description>The investigators will compare total morphine demand in both groups during the first 24h after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first request for morphine</measure>
    <time_frame>During 24 hours postoperative</time_frame>
    <description>The investigators will compare the timing of the first request for morphine in both groups during the first 24h after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement of rescue analgesia</measure>
    <time_frame>During 24 hours postoperative</time_frame>
    <description>The investigators will record and compare the timing of first rescue analgesia and total rescue analgesia requirement.&#xD;
If 6&lt;VAS&lt;8: paracetamol 1g iv will be administered If VAS&gt;8:paracetamol 1g iv associated to ketoprofen100mg IM will be administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total intraoperative consumption of Fentanyl.</measure>
    <time_frame>Intraoperative period</time_frame>
    <description>The investigators will record the total dose of Fentanyl (µg) required during surgery.&#xD;
Fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting</measure>
    <time_frame>within 24 hours postoperative</time_frame>
    <description>Incidence of postoperative nausea and vomiting will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphine related side effects</measure>
    <time_frame>During 24 hours postoperative</time_frame>
    <description>The occurence of morphine related side effects such as pruritus,urinary retention,hypotension,respiratory distress and sedation will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer Surgery</condition>
  <condition>Postoperative Analgesia</condition>
  <arm_group>
    <arm_group_label>group B:ESP block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc)&#xD;
An intravenous patient controlled analgesia device will be given to the patients postoperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group P: Sham ESP block</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected&#xD;
-An intravenous patient controlled analgesia device will be given to the patients postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>erector spinae plane block</intervention_name>
    <description>The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.</description>
    <arm_group_label>group B:ESP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sham erector spinae plane block</intervention_name>
    <description>The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.</description>
    <arm_group_label>group P: Sham ESP block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  25-65 years old&#xD;
&#xD;
          -  ASA I-II&#xD;
&#xD;
          -  Undergoing unilateral breast cancer surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obesity (body mass index &gt;40 kg/m2)&#xD;
&#xD;
          -  Preoperative chronic dependence upon opioid and NSAID medications&#xD;
&#xD;
          -  History of psychiatric or neurological disease&#xD;
&#xD;
          -  Patients with chronic pain syndromes&#xD;
&#xD;
          -  allergy to local anaesthetics&#xD;
&#xD;
          -  other contraindications to peripheral nerve blocks&#xD;
&#xD;
          -  Patients' refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hayen Maghrebi, PROFESSOR</last_name>
    <role>Study Chair</role>
    <affiliation>UNIVERSITY OF TUNIS EL MANAR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tunis maternity and neonatology center,</name>
      <address>
        <city>Tunis</city>
        <zip>1007</zip>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 19, 2019</last_update_submitted>
  <last_update_submitted_qc>December 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Tunis El Manar</investigator_affiliation>
    <investigator_full_name>Ben marzouk Sofiene</investigator_full_name>
    <investigator_title>clinical associate professor</investigator_title>
  </responsible_party>
  <keyword>opioid consumption</keyword>
  <keyword>erector spinae plane block</keyword>
  <keyword>breast surgery</keyword>
  <keyword>analgesia</keyword>
  <keyword>PCA morphine</keyword>
  <keyword>Locoregional anesthesia</keyword>
  <keyword>breast cancer surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_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/NCT03769428
org study id: erector-spinae
nct id: NCT03769428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Breast cancer surgery is one of the most common surgeries, due to the high incidence of
      breast cancer. Unfortunately, patients experience significant postoperative acute pain,
      placing them at risk for increased clinical morbidity and the development of disabling
      chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by
      the patient is one of the best predictors of chronic pain.

      However, postoperative analgesia in breast cancer surgery is difficult due to the extensive
      nature of the surgery and the complex innervation of the breast.

      Several newly described regional anesthesia techniques exist to control perioperative pain,
      including the Paravertebral block (PVB) which has been proved to be the most effective one.
      The anatomic proximity of the pleura and central neuraxial system makes it a particularly
      challenging technique and carrying a risk of pneumothorax.

      The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero
      et al in September 2016. Local anesthetic injection is performed beneath the erector spinae
      muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral
      levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal
      nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the
      context of surgical pain during breast cancer surgery.

      There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in
      controlling post-operative breast surgery pain.

      The main purpose of this study is to evaluate the postoperative analgesic effect of
      Ultrasound-guided ESPB in patients undergoing breast cancer surgery.
It is a prospective double blind trial. Sixty female patient aged between 20-65 years old
      with American Society of Anesthesiologists (ASA) physical status I-II and scheduled for
      elective surgery for breast cancer were included in the study. Only unilateral surgical
      procedures will be included. The patients will be randomized into two groups:

      Group B (ESP block): Patients in the experimental arm will receive an ESPB prior to induction
      of general anesthetic.

      Group P: (sham ESP block): Patients allocated to the placebo-control arm will receive a
      placebo injection of normal saline in almost identical fashion to that of the ESP block.

      Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the
      contralateral upper limb of the surgical site and monitors (pulse oximeter,
      electrocardiography, non-invasive blood pressure (NIBP) will be applied.

      All blocks will be performed before induction of general anesthesia.

      ESPB technique:

      The ESPB will be done in the sitting position using linear ultrasound probe (L10) of MySonoU6
      machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane
      approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal
      approach. Three muscles will be identified superficial to the transverse process shadow as
      follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected
      between the erector spinae muscle and transverse process. Following confirmation of the
      correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40
      mL of fluid will be injected next. The distribution will be observed in both cranial and
      caudal directions.

        -  Group B (ESP block) will receive 150 mg of Ropivacaine : 40cc of Ropivacaine
           (3.75mg/cc).

        -  Group P (Sham ESP block) will receive 40 cc of normal saline.

      General Anesthesia:

      All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced
      by using fentanyl 2μg/kg, Propofol 2-3 mg/kg and Atracurium 0.5 mg/kg. During anesthesia
      maintenance, monitoring will include Pulse Oximetry, an Electrocardiogram, Non-Invasive Blood
      Pressure (NIBP), end-tidal Carbon Dioxide, End-Tidal Sevoflurane, and Fraction of Inspired
      Oxygen.

      The reinjection of 0.5μg/kg of fentanyl will be given intraoperatively either when heart rate
      or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal
      records.

      Paracetamol 1 g IV and Ketoprofen 100 mg intramuscular (IM) will be administered for
      postoperative analgesia at the end of surgery. Anesthesia will be discontinued and tracheal
      extubation will be done once patient fulfilled the extubation criteria. In the recovery room,
      all patients will be given a patient-controlled analgesia device (PCA) containing morphine 1
      mg/ml-1 ,set to deliver a 1 mg bolus dose of morphine, with an 5 min lockout time and 12mg 1
      h limit. Postoperative pain will be assessed using a visual analogue scales (VAS) scores
      ranging from zero (no pain) to 10 (worst imaginable pain). The VAS scores will be recorded at
      1,2,4,8 6, 12, 16, 20 and 24 h postoperatively.If VAS scores are superior to 6 the
      investigators will resort to rescue analgesia as following: If 6<VAS<8: paracetamol 1g IV
      will be administered and if VAS>8: paracetamol 1g IV associated to ketoprofen100mg IM.

      Incidence of nausea and vomiting, and total morphine consumption during the 24-h
      postoperative period will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Comparing morphine consumption rates within 24h postoperative
time frame: The first 24 hours postoperative
description: All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.
measure: Assessment of pain in postoperative period via visual analogue scales (VAS) .
time frame: The first 24 hours postoperative
description: Postoperative pain will be assessed using a VAS ranging from 0 (no pain) to 10 (worst imaginable pain).The VAS will be recorded at 1,2,4,8 6, 12 ,16,20 and 24 h postoperatively.
measure: Total morphine demand
time frame: During 24 hours postoperative
description: The investigators will compare total morphine demand in both groups during the first 24h after surgery.
measure: Time to first request for morphine
time frame: During 24 hours postoperative
description: The investigators will compare the timing of the first request for morphine in both groups during the first 24h after surgery.
measure: Requirement of rescue analgesia
time frame: During 24 hours postoperative
description: The investigators will record and compare the timing of first rescue analgesia and total rescue analgesia requirement.
If 6<VAS<8: paracetamol 1g iv will be administered If VAS>8:paracetamol 1g iv associated to ketoprofen100mg IM will be administered.
measure: Total intraoperative consumption of Fentanyl.
time frame: Intraoperative period
description: The investigators will record the total dose of Fentanyl (µg) required during surgery.
Fentanyl will be given intraoperatively either when heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records.
measure: Postoperative nausea and vomiting
time frame: within 24 hours postoperative
description: Incidence of postoperative nausea and vomiting will be recorded.
measure: Morphine related side effects
time frame: During 24 hours postoperative
description: The occurence of morphine related side effects such as pruritus,urinary retention,hypotension,respiratory distress and sedation will be recorded.
arm group label: group B:ESP block
arm group type: Active Comparator
description: Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc)
An intravenous patient controlled analgesia device will be given to the patients postoperatively
arm group label: group P: Sham ESP block
arm group type: Placebo Comparator
description: Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected
-An intravenous patient controlled analgesia device will be given to the patients postoperatively
intervention type: Procedure
intervention name: erector spinae plane block
description: The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.
arm group label: group B:ESP block
intervention type: Procedure
intervention name: sham erector spinae plane block
description: The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.
arm group label: group P: Sham ESP block
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hayen Maghrebi, PROFESSOR
role: Study Chair
affiliation: UNIVERSITY OF TUNIS EL MANAR
facility: 
country: Tunisia
responsible party type: Sponsor-Investigator
investigator affiliation: University Tunis El Manar
investigator full name: Ben marzouk Sofiene
investigator title: clinical associate professor
mesh term: Breast Neoplasms