<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/NCT04498234</url>
  </required_header>
  <id_info>
    <org_study_id>Romany SECI</org_study_id>
    <nct_id>NCT04498234</nct_id>
  </id_info>
  <brief_title>Comparison Between U\S Guided Erector Spinaeblock and Paravertebral Block on Acute and Chronic Post Mastectomy Pain</brief_title>
  <official_title>Comparison Between Ultrasound Guided Erector Spinae Plane Block and Paravertebral Block on Acute and Chronic Postmastectomy Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South Egypt Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>South Egypt Cancer Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      compare between ultrasound guided erector spinae plane block and ultrasound guided&#xD;
      paravertebral block on acute and chronic post mastectomy pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Management of postoperative analgesia following breast surgery extending beyond a simple&#xD;
      lumpectomy can sometimes be a challenge, especially when such surgery is being performed as a&#xD;
      day-case procedure. Patients undergoing mastectomy have a very high possibility of developing&#xD;
      postsurgical pain syndrome, as high as 20% to 50%.There has been some evidence to suggest&#xD;
      regional analgesia techniques reduce the incidence of postsurgical pain in patients&#xD;
      undergoing mastectomy. This underlines the importance of performing regional anaesthetic and&#xD;
      analgesic techniques for postoperative analgesia following breast surgery.There are many&#xD;
      techniques of regional analgesia as thorasic epidural block , paravertebral block , PECS1&#xD;
      block ,PECS2 block , and recently erector spinae plan block.Paravertebral blocks have&#xD;
      superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to&#xD;
      provide analgesia for breast surgery.The injection of local anaesthetic solution in the&#xD;
      paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic.&#xD;
      The uptake of the local anaesthetic solution is enhanced due to the absence of fascial&#xD;
      sheaths binding the spinal nerves.TPVB produces ipsilateral somatic and sympathetic nerve&#xD;
      blockade due to a direct effect of the local anesthetic on the somatic and sympathetic nerves&#xD;
      in the TPVS, extension into the intercostal space laterally, and the epidural space medially.&#xD;
      Ultrasound-guided erector spinae plane (US-ESP) block is a novel analgesic technique, in&#xD;
      which local anaesthetic is injected into fascial plane deep to erector spinae muscle. It is&#xD;
      possible to block the dorsal and ventral rami of the spinal nerve depending on the level of&#xD;
      injection and amount of local anaesthetic injected. Erector spinae block (ESP) leads to&#xD;
      effective post-operative analgesia where it is performed at T4-5 level for breast cancer and&#xD;
      thoracic surgery , when performed bilaterally it has been reported to be as effective as&#xD;
      thoracic epidural analgesia.The drug spreads in craniocaudal fashion over several levels as&#xD;
      the erector spinae fascia extends from nuchal fascia cranially to the sacrum caudally. Forero&#xD;
      et al. recently described US-ESP block for thoracic neuropathic pain. This block could be&#xD;
      effective in both acute post-operative thoracic and abdominal surgeries and also neuropathic&#xD;
      pain in these regions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>analgesic requirement</measure>
    <time_frame>24 hours</time_frame>
    <description>Total morphine consumption during first 24 hours post operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stress response</measure>
    <time_frame>24 hours</time_frame>
    <description>Effect on stress response: serum level of cortisol and noradrenaline (immediately preoperative, after intubation, immediately postoperative, and after 24 hours postoperative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic post mastectomy pain</measure>
    <time_frame>6 month</time_frame>
    <description>Chronic post mastectomy will be assessed at pain clinic at 1st, 3rd, 6 th month postoperatively using (LANSS ) score .</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Compare Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Para-vertebral Block on Acute and Chronic Post Mastectomy Pain</condition>
  <arm_group>
    <arm_group_label>GROUP(A) (CONTROL GROUP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive standard regimen of anesthesia .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %</intervention_name>
    <description>One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .</description>
    <arm_group_label>GROUP(A) (CONTROL GROUP)</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender : female .&#xD;
&#xD;
          2. Age : 20 to 70 years old .&#xD;
&#xD;
          3. Scheduled for : either left or right modified radical mastectomy (MRM)&#xD;
&#xD;
          4. Physical status : American society of anesthesiologists (ASA) physical status I and&#xD;
             II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1-ASA &gt; III 2 -age&gt; 70 years old. 3-patients refusal to the procedure. 4-Infection of the&#xD;
        skin at or near site of needle puncture. 5- Coagulopathy . 6- Drug hypersensitivity or&#xD;
        allergy to the studied drugs. 7- Central or peripheral neuropthy . 8-Pre-operative opoid&#xD;
        consumption ( within 24 hours preoperative ) 9- Anomalies of the vertebral column .&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romany G. Naeem, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>assistant lecturer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Romany G. Naeem, MSc</last_name>
    <phone>1006231332</phone>
    <phone_ext>0020</phone_ext>
    <email>Romanytreka22@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>South Egypt Cancer Institute</name>
      <address>
        <city>Assiut</city>
        <zip>171516</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romany G. Naeem, MSc</last_name>
      <phone>1006231332</phone>
      <phone_ext>0020</phone_ext>
      <email>Romanytreka22@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>South Egypt Cancer Institute</investigator_affiliation>
    <investigator_full_name>Romany Gergis Naeem Gendy</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT04498234
org study id: Romany SECI
nct id: NCT04498234
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
compare between ultrasound guided erector spinae plane block and ultrasound guided
      paravertebral block on acute and chronic post mastectomy pain
Management of postoperative analgesia following breast surgery extending beyond a simple
      lumpectomy can sometimes be a challenge, especially when such surgery is being performed as a
      day-case procedure. Patients undergoing mastectomy have a very high possibility of developing
      postsurgical pain syndrome, as high as 20% to 50%.There has been some evidence to suggest
      regional analgesia techniques reduce the incidence of postsurgical pain in patients
      undergoing mastectomy. This underlines the importance of performing regional anaesthetic and
      analgesic techniques for postoperative analgesia following breast surgery.There are many
      techniques of regional analgesia as thorasic epidural block , paravertebral block , PECS1
      block ,PECS2 block , and recently erector spinae plan block.Paravertebral blocks have
      superseded thoracic epidurals when it comes to choice of a regional anaesthesia technique to
      provide analgesia for breast surgery.The injection of local anaesthetic solution in the
      paravertebral space results in a unilateral block, which is sensory, motor, and sympathetic.
      The uptake of the local anaesthetic solution is enhanced due to the absence of fascial
      sheaths binding the spinal nerves.TPVB produces ipsilateral somatic and sympathetic nerve
      blockade due to a direct effect of the local anesthetic on the somatic and sympathetic nerves
      in the TPVS, extension into the intercostal space laterally, and the epidural space medially.
      Ultrasound-guided erector spinae plane (US-ESP) block is a novel analgesic technique, in
      which local anaesthetic is injected into fascial plane deep to erector spinae muscle. It is
      possible to block the dorsal and ventral rami of the spinal nerve depending on the level of
      injection and amount of local anaesthetic injected. Erector spinae block (ESP) leads to
      effective post-operative analgesia where it is performed at T4-5 level for breast cancer and
      thoracic surgery , when performed bilaterally it has been reported to be as effective as
      thoracic epidural analgesia.The drug spreads in craniocaudal fashion over several levels as
      the erector spinae fascia extends from nuchal fascia cranially to the sacrum caudally. Forero
      et al. recently described US-ESP block for thoracic neuropathic pain. This block could be
      effective in both acute post-operative thoracic and abdominal surgeries and also neuropathic
      pain in these regions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: analgesic requirement
time frame: 24 hours
description: Total morphine consumption during first 24 hours post operatively.
measure: stress response
time frame: 24 hours
description: Effect on stress response: serum level of cortisol and noradrenaline (immediately preoperative, after intubation, immediately postoperative, and after 24 hours postoperative)
measure: Chronic post mastectomy pain
time frame: 6 month
description: Chronic post mastectomy will be assessed at pain clinic at 1st, 3rd, 6 th month postoperatively using (LANSS ) score .
arm group label: GROUP(A) (CONTROL GROUP)
arm group type: Experimental
description: Patients will receive standard regimen of anesthesia .
arm group label: Group B
arm group type: Experimental
description: Patients will receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4.
arm group label: Group C
arm group type: Experimental
description: Patients will receive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
intervention type: Procedure
intervention name: ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %
description: One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
arm group label: GROUP(A) (CONTROL GROUP)
arm group label: Group B
arm group label: Group C
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Romany G. Naeem, MSc
role: Principal Investigator
affiliation: assistant lecturer
last name: Romany G. Naeem, MSc
phone: 1006231332
phone ext: 0020
email: Romanytreka22@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: South Egypt Cancer Institute
investigator full name: Romany Gergis Naeem Gendy
investigator title: assistant lecturer
mesh term: Bupivacaine