<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/NCT04486014</url>
  </required_header>
  <id_info>
    <org_study_id>MD.20.04.307</org_study_id>
    <nct_id>NCT04486014</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Erector Spinae Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy</brief_title>
  <official_title>A Comparative Study of the Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      -  Thoracic incisions are painful and associated with chronic post-surgical pain and&#xD;
           inadequate analgesia is associated with poorer postoperative outcomes. Recent progress&#xD;
           has been made in the field of thoracic anesthesia by improving analgesic modalities such&#xD;
           as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia,&#xD;
           ultrasound-guided erector spinae and serratus anterior plane block.&#xD;
&#xD;
        -  Administered of the local anesthetic in erector spinae plane block is in the&#xD;
           interfascial plane between the transverse process of the vertebra and the erector spinae&#xD;
           muscles, spreading to multiple paravertebral spaces. It affects both the ventral and&#xD;
           dorsal rami and leading to blockage of both visceral and somatic pain.&#xD;
&#xD;
        -  Ultrasound-guided serratus anterior plane block is a facial plane block that provides&#xD;
           analgesia by blocking of lateral branches of intercostal nerves above or below the&#xD;
           serratus plane muscle.&#xD;
&#xD;
        -  We hypothesize that the ultrasound-guided erector spinae plane block may have better&#xD;
           quality than the serratus anterior plane block for patients undergoing thoracoscopic&#xD;
           sympathectomy as erector spinea plane blocks visceral and somatic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on&#xD;
      the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH&#xD;
      demonstrates no obvious organic cause; however, some patients may feel distressed because&#xD;
      their palms sweat more than normal, and such a situation may lead to severe psychological,&#xD;
      social, and occupational dysfunction.&#xD;
&#xD;
      Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the&#xD;
      postganglionic fibers with its complications which include post-sympathetic neuralgia which&#xD;
      is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no&#xD;
      response to the operation and compensatory hyperhidrosis in non-denervated areas.&#xD;
&#xD;
      Forero described ultrasound-guided erector spinae plane block for treatment of thoracic&#xD;
      neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that&#xD;
      has been used for prevention of postoperative pain in various surgeries.&#xD;
&#xD;
      Ultrasound-guided serratus anterior plane block is a facial plane block which provides&#xD;
      analgesia by blocking of lateral branches of intercostal nerves above or below the serratus&#xD;
      plane muscle. There are few cases and studies in the literature reporting successful&#xD;
      analgesia provided by serratus anterior plane block&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">July 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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single-blind (participant) study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The total analgesic consumption</measure>
    <time_frame>1st 24 hours after surgery</time_frame>
    <description>cumulative consumption of opioids during the first postoperative day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative severity of the pain</measure>
    <time_frame>every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively</time_frame>
    <description>Visual analogue scale (0-100),where 0 point is equal to no pain and 100 indicate the worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total amount of fentanyl consumption</measure>
    <time_frame>1st 24 hours after surgery</time_frame>
    <description>cumulative consumption of fentanyl during the first postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The total amount of paracetamol consumption</measure>
    <time_frame>1st 24 hours after surgery</time_frame>
    <description>cumulative consumption of paracetamol during the first post operative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of analgesia</measure>
    <time_frame>within 24 hours after surgery</time_frame>
    <description>from the end of block till the time for the first analgesic requirement (ketorolac)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>1st 24 hours after surgery</time_frame>
    <description>number of patients with nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting</measure>
    <time_frame>1st 24 hours after surgery</time_frame>
    <description>number of patients with vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>After 12 and 24 hours after surgery</time_frame>
    <description>evaluated as 5:excellent, 4:very good, 3:good, 2: fair, 1:poor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in Peripheral oxygen saturation as measured with pulse oximetry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-tidal carbon dioxide tension</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in end-tidal carbon dioxide tension as measured with capnography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in systolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressures</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in diastolic blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean blood pressures</measure>
    <time_frame>Intraoperative (every 10 minutes till the end of surgery)</time_frame>
    <description>changes in mean arterial blood pressure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Thoracic Sympathectomy</condition>
  <arm_group>
    <arm_group_label>Erector spinae plane block (ESP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients would receive erector spinae plane block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serratus anterior plane block (SAP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients would receive serratus anterior plane block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector spinae plane block</intervention_name>
    <description>Erector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4</description>
    <arm_group_label>Erector spinae plane block (ESP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Serratus anterior plane block</intervention_name>
    <description>Serratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line</description>
    <arm_group_label>Serratus anterior plane block (SAP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists grade I or II physical status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had coagulopathies&#xD;
&#xD;
          -  local infections&#xD;
&#xD;
          -  neuropathies&#xD;
&#xD;
          -  neuromuscular disease&#xD;
&#xD;
          -  psychiatric disease&#xD;
&#xD;
          -  history of thoracic surgery&#xD;
&#xD;
          -  history of allergy to local anesthetics.&#xD;
&#xD;
          -  receiving chronic analgesic therapy&#xD;
&#xD;
          -  drug abusers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Y Makharita, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Anesthesia and Surgical Intensive care,P</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Doaa G Diab, MD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Anesthesia and Surgical Intensive care,</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed Y Makharita, MD</last_name>
    <phone>00201284122800</phone>
    <email>m_younis24@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Doaa G Diab, MD</last_name>
    <phone>00201069507088</phone>
    <email>basmalg@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Y Makharita, MD</last_name>
      <phone>00201284122800</phone>
      <email>m_younis24@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Doaa G Diab, MD</last_name>
      <phone>00201069507088</phone>
      <email>basmalg@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ahmed M Abozeid, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed Y Abd-alla, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>after completing the study and being accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients</ipd_access_criteria>
  </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/NCT04486014
org study id: MD.20.04.307
nct id: NCT04486014
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
-  Thoracic incisions are painful and associated with chronic post-surgical pain and
           inadequate analgesia is associated with poorer postoperative outcomes. Recent progress
           has been made in the field of thoracic anesthesia by improving analgesic modalities such
           as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia,
           ultrasound-guided erector spinae and serratus anterior plane block.

        -  Administered of the local anesthetic in erector spinae plane block is in the
           interfascial plane between the transverse process of the vertebra and the erector spinae
           muscles, spreading to multiple paravertebral spaces. It affects both the ventral and
           dorsal rami and leading to blockage of both visceral and somatic pain.

        -  Ultrasound-guided serratus anterior plane block is a facial plane block that provides
           analgesia by blocking of lateral branches of intercostal nerves above or below the
           serratus plane muscle.

        -  We hypothesize that the ultrasound-guided erector spinae plane block may have better
           quality than the serratus anterior plane block for patients undergoing thoracoscopic
           sympathectomy as erector spinea plane blocks visceral and somatic pain.
Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on
      the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH
      demonstrates no obvious organic cause; however, some patients may feel distressed because
      their palms sweat more than normal, and such a situation may lead to severe psychological,
      social, and occupational dysfunction.

      Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the
      postganglionic fibers with its complications which include post-sympathetic neuralgia which
      is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no
      response to the operation and compensatory hyperhidrosis in non-denervated areas.

      Forero described ultrasound-guided erector spinae plane block for treatment of thoracic
      neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that
      has been used for prevention of postoperative pain in various surgeries.

      Ultrasound-guided serratus anterior plane block is a facial plane block which provides
      analgesia by blocking of lateral branches of intercostal nerves above or below the serratus
      plane muscle. There are few cases and studies in the literature reporting successful
      analgesia provided by serratus anterior plane block
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Single-blind (participant) study
measure: The total analgesic consumption
time frame: 1st 24 hours after surgery
description: cumulative consumption of opioids during the first postoperative day
measure: Postoperative severity of the pain
time frame: every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively
description: Visual analogue scale (0-100),where 0 point is equal to no pain and 100 indicate the worst possible pain
measure: The total amount of fentanyl consumption
time frame: 1st 24 hours after surgery
description: cumulative consumption of fentanyl during the first postoperative day
measure: The total amount of paracetamol consumption
time frame: 1st 24 hours after surgery
description: cumulative consumption of paracetamol during the first post operative day
measure: Duration of analgesia
time frame: within 24 hours after surgery
description: from the end of block till the time for the first analgesic requirement (ketorolac)
measure: Nausea
time frame: 1st 24 hours after surgery
description: number of patients with nausea
measure: Vomiting
time frame: 1st 24 hours after surgery
description: number of patients with vomiting
measure: Patient Satisfaction
time frame: After 12 and 24 hours after surgery
description: evaluated as 5:excellent, 4:very good, 3:good, 2: fair, 1:poor
measure: Heart rate
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in heart rate
measure: Peripheral oxygen saturation
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in Peripheral oxygen saturation as measured with pulse oximetry
measure: End-tidal carbon dioxide tension
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in end-tidal carbon dioxide tension as measured with capnography
measure: systolic blood pressure
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in systolic blood pressure
measure: diastolic blood pressures
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in diastolic blood pressure
measure: mean blood pressures
time frame: Intraoperative (every 10 minutes till the end of surgery)
description: changes in mean arterial blood pressure
arm group label: Erector spinae plane block (ESP)
arm group type: Experimental
description: Patients would receive erector spinae plane block
arm group label: Serratus anterior plane block (SAP)
arm group type: Experimental
description: Patients would receive serratus anterior plane block
intervention type: Procedure
intervention name: Erector spinae plane block
description: Erector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4
arm group label: Erector spinae plane block (ESP)
intervention type: Procedure
intervention name: Serratus anterior plane block
description: Serratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line
arm group label: Serratus anterior plane block (SAP)
criteria: 
gender: All
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: No
last name: Mohamed Y Makharita, MD
role: Study Chair
affiliation: Professor of Anesthesia and Surgical Intensive care,P
last name: Doaa G Diab, MD
role: Study Director
affiliation: Associate Professor of Anesthesia and Surgical Intensive care,
last name: Mohamed Y Makharita, MD
phone: 00201284122800
email: m_younis24@yahoo.com
last name: Doaa G Diab, MD
phone: 00201069507088
email: basmalg@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Egypt
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: after completing the study and being accepted for publication.
ipd access criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients