<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/NCT03749395</url>
  </required_header>
  <id_info>
    <org_study_id>Erector spinae block</org_study_id>
    <nct_id>NCT03749395</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients</brief_title>
  <official_title>Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy Patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha 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>
      aim of this study is to assess and compare between the efficacy of the new U/S guided erector&#xD;
      spinae plane block (ESP) and the conventional methods of systemic analgesics in adult&#xD;
      patients scheduled for elective thoracotomy surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thoracotomy is considered the most painful of surgical procedures and providing effective&#xD;
      analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing,&#xD;
      coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae&#xD;
      plane (ESP) block is a newly-described technique for treating thoracic pain, and has several&#xD;
      advantages that make it an attractive alternative to these more invasive&#xD;
      procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique,&#xD;
      recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is&#xD;
      reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral&#xD;
      rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the&#xD;
      paravertebral space . When performed bilaterally it has been reported to be as effective as&#xD;
      thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when&#xD;
      performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed&#xD;
      as follow:The patient will be placed in a sitting position and the ultrasound probe will be&#xD;
      placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles&#xD;
      were identified superficial to the hyperechoic transverse process shadow as follows:&#xD;
      trapezius, rhomboid major, and erector spinae . the needle will be inserted in a&#xD;
      cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced&#xD;
      by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25%&#xD;
      bupivacaine will be injected here.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">November 5, 2019</completion_date>
  <primary_completion_date type="Actual">November 5, 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>Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The practitioner and the patient are not blinded.The outcomes assessor will not know which group each patient is in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>24 hours morphine consumption</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>total morphine consumption in both groups will be assessed in the postoperative period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The quality of analgesia based on visual analogue scale (VAS) pain scores.</measure>
    <time_frame>every 6 hours for 24 hours</time_frame>
    <description>VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of opioid usage</measure>
    <time_frame>2, 6, 12, 24 hours postoperative</time_frame>
    <description>Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural morbidity</measure>
    <time_frame>2, 6, 12, 24 hours postoperative</time_frame>
    <description>Any evidence of procedure-related morbidity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Erector Spinae Plane Block group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.&#xD;
All patients will receive general anesthesia as described in conventional group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nothing will be injected&#xD;
All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector Spinae Plane Block</intervention_name>
    <description>The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.</description>
    <arm_group_label>Erector Spinae Plane Block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged &gt;18 years&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status I or IV scheduled for elective&#xD;
             thoracotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient to provide written consent&#xD;
&#xD;
          -  history of relevant drug allergy&#xD;
&#xD;
          -  age less than 18&#xD;
&#xD;
          -  obesity BMI &gt; 40 kg/m2&#xD;
&#xD;
          -  infection of the skin at the site of needle puncture area&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  Pregnant females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>faculty of medicine</last_name>
    <role>Study Director</role>
    <affiliation>faculty of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banha University Hospital</name>
      <address>
        <city>Banhā</city>
        <zip>13518</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.</citation>
    <PMID>27501016</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>August 16, 2020</last_update_submitted>
  <last_update_submitted_qc>August 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>mohammed gomaa sobhy</investigator_full_name>
    <investigator_title>Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03749395
org study id: Erector spinae block
nct id: NCT03749395
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
aim of this study is to assess and compare between the efficacy of the new U/S guided erector
      spinae plane block (ESP) and the conventional methods of systemic analgesics in adult
      patients scheduled for elective thoracotomy surgery.
Thoracotomy is considered the most painful of surgical procedures and providing effective
      analgesia is the onus for all anesthetists. Ineffective pain relief impedes deep breathing,
      coughing, and remobilization culminating in atelectasis and pneumonia.The erector spinae
      plane (ESP) block is a newly-described technique for treating thoracic pain, and has several
      advantages that make it an attractive alternative to these more invasive
      procedures.Ultrasound guided erector spinae (ESP) block is a regional anesthesia technique,
      recently described by (Forero; et al.) for use in thoracic neuropathic pain. ESP block is
      reported to lead to analgesic effect on somatic and visceral pain by effecting the ventral
      rami and rami communicantes that include sympathetic nerve fibers, as LA spreads through the
      paravertebral space . When performed bilaterally it has been reported to be as effective as
      thoracic epidural analgesia.ESP block leads to effective postoperative analgesia when
      performed at T 4-5 level for breast and thoracic surgery. The ESP block , will be performed
      as follow:The patient will be placed in a sitting position and the ultrasound probe will be
      placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles
      were identified superficial to the hyperechoic transverse process shadow as follows:
      trapezius, rhomboid major, and erector spinae . the needle will be inserted in a
      cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced
      by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25%
      bupivacaine will be injected here.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two parallel arms. One group will receive erector spinae plane block, and the other will receive nothing.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The practitioner and the patient are not blinded.The outcomes assessor will not know which group each patient is in.
measure: 24 hours morphine consumption
time frame: 24 hours postoperative
description: total morphine consumption in both groups will be assessed in the postoperative period
measure: The quality of analgesia based on visual analogue scale (VAS) pain scores.
time frame: every 6 hours for 24 hours
description: VAS score will be obtained in the postoperative period at preset time intervals.Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
measure: Side effects of opioid usage
time frame: 2, 6, 12, 24 hours postoperative
description: Any evidence of opioid-related morbidity or adverse effects eg. nausea,vomiting,pruritus.These effects will be assessed by questionnaire.
measure: Procedural morbidity
time frame: 2, 6, 12, 24 hours postoperative
description: Any evidence of procedure-related morbidity
arm group label: Erector Spinae Plane Block group
arm group type: Active Comparator
description: The Erector Spinae Plane block will be done as follow,the patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
All patients will receive general anesthesia as described in conventional group
arm group label: Conventional group
arm group type: No Intervention
description: Nothing will be injected
All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of EtCo2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperative when either heart rate or Non Invasive Blood Pressure report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.
intervention type: Procedure
intervention name: Erector Spinae Plane Block
description: The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
arm group label: Erector Spinae Plane Block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: faculty of medicine
role: Study Director
affiliation: faculty of medicine
facility: 
country: Egypt
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PMID: 27501016
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: mohammed gomaa sobhy
investigator title: Ultrasound Guided Erector Spinae Block for Postoperative Analgesia in Thoracotomy patients : A Prospective, Randomized, Observer-Blind,Controlled Clinical Trial
mesh term: Pain, Postoperative