<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/NCT03797079</url>
  </required_header>
  <id_info>
    <org_study_id>ESP Block for Chest Trauma</org_study_id>
    <nct_id>NCT03797079</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma</brief_title>
  <official_title>Erector Spinae Plane Block Versus Thoracic Epidural Block as Analgesic Techniques for Chest Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sameh Fathy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      Rib fractures are very common as a consequence of blunt chest trauma which is associated with&#xD;
      severe pain, morbidity and mortality. The key to managing these patients is prompt and&#xD;
      effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The&#xD;
      aim of this study is to compare and evaluate the differences between either continuous&#xD;
      erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic&#xD;
      modalities in patients with chest trauma. It is hypothesized that ESP block will be&#xD;
      comparable to TEA as a promising effective analgesic alternative with fewer side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trauma is a major cause of morbidity and mortality worldwide as a leading cause of death. Rib&#xD;
      fractures are very common and are detected in at least 10% of all injured patients, the&#xD;
      majority of which are as a consequence of blunt chest trauma. Chest trauma are associated&#xD;
      with severe pain, morbidity and mortality, as it contributes to atelectasis, lobar collapse,&#xD;
      pneumonia, effusion, aspiration, acute respiratory distress syndrome pulmonary embolism,&#xD;
      increased intensive care admissions, and poor overall clinical outcomes. Trauma is associated&#xD;
      with release of cytokines, which contribute to the development of hemodynamic instability and&#xD;
      metabolic derangement, which can worsen prognosis. The efficacy of utilizing different&#xD;
      modalities for analgesia in controlling extent of tissue damage can be compared by measuring&#xD;
      these cytokines levels. Multiple analgesic modalities have been used in these patients with&#xD;
      chest trauma, such as oral analgesics, intravenous opioids, patient-controlled opioid&#xD;
      analgesia, inter-pleural blocks, intercostal blocks, serratus plane blocks, paravertebral&#xD;
      blocks, and TEA. In trauma patients with rib fractures, retrospective studies showed that TEA&#xD;
      has become the gold standard of care, while ultrasound-guided paravertebral and serratus&#xD;
      plane blocks are possible alternatives. However, no single best analgesic modality could be&#xD;
      recommended or established, based on available data in this population, as no meta-analysis&#xD;
      on this topic has yet been completed. Ultrasound has been the fundamental tool for a&#xD;
      significant improvement in the progress of regional analgesic techniques of inter-fascial&#xD;
      chest wall blocks, allowing their description and introduction into clinical practice.&#xD;
      Ultrasound-guided ESP block is a new technique that has been recently described in the&#xD;
      control of both chronic neuropathic pain as well as acute postsurgical or post-traumatic pain&#xD;
      of the chest wall. The ESP block holds promise as a simple, easy, fast and safe technique for&#xD;
      thoracic analgesia in the context of pain associated with chest trauma.&#xD;
&#xD;
      Aim of the Study:&#xD;
&#xD;
      The aim of this study is to assess the quality of pain relief and improvement of pulmonary&#xD;
      function in patients with chest trauma receiving either continuous ESP block or TEA by&#xD;
      comparing and evaluating the differences between the two techniques. It is hypothesized that&#xD;
      ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer&#xD;
      side effects.&#xD;
&#xD;
      Sample Size Calculation:&#xD;
&#xD;
      The literature available on ESP block is limited to some sporadic case reports and&#xD;
      editorials. Hence, this clinical trial will be conducted on 50 patients and post hoc analysis&#xD;
      will be performed using pain scores obtained from the present study with an α (type I error)&#xD;
      = 0.05 and β (type II error) = 0.2 (power = 80%).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The study will be conducted in Mansoura Emergency Hospital on fifty patients admitted with&#xD;
      chest trauma. They will be randomly assigned to two equal groups (ESP group and TEA group)&#xD;
      according to computer-generated table of random numbers using the permuted block&#xD;
      randomization method. The group allocation will be concealed in sequentially numbered, sealed&#xD;
      opaque envelopes which will be opened only after obtaining the written informed consent.&#xD;
      Patient demographic data including age, sex, body weight, and status of American Society of&#xD;
      Anesthesiologists (ASA) will be recorded. A written informed consent will be obtained from&#xD;
      all study subjects after ensuring confidentiality. The study protocol will be explained to&#xD;
      all patients after enrollment into the study. In both groups, catheter-based analgesia will&#xD;
      be performed with a bolus dose of bupivacaine followed by a continuous infusion for 48 hours.&#xD;
      Later on, the catheters will be removed, and the pain management will be switched to parental&#xD;
      or oral analgesics.&#xD;
&#xD;
      Statistical Methods:&#xD;
&#xD;
      The collected data will be coded, processed, and analyzed using Statistical Package for the&#xD;
      Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data&#xD;
      distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will&#xD;
      be presented as mean ± standard deviation, and compared with the unpaired student's t test.&#xD;
      Non-normally distributed data will be presented as median (range), and compared with the&#xD;
      Mann-Whitney U test. Repeated measures analysis of variance (ANOVA) test will be used for&#xD;
      comparisons within the same group. Categorical data will be presented as number (percentage),&#xD;
      and compared with the Chi-square test. All data will be considered statistically significant&#xD;
      if P value is ≤ 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2020</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>Prospective, randomized, double blind study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in pain scores by Visual analogue scale (VAS)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total analgesic requirements of fentanyl</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 48 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First analgesic request</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>The time of the first analgesic request for fentanyl will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate (HR)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>HR will be recorded every two hours for 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mean arterial blood pressure (MAP)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>MAP will be recorded every two hours for 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>FEV1 will be assessed by spirometry before and 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in forced vital capacity (FVC)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>FVC will be assessed by spirometry before and 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in forced expiratory flow (FEF 25-75%)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in the level of tumor necrosis factor alpha (TNF-α)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>TNF-α will be measured before, 24, 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in the level of interleukin 6 (IL-6)</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>IL-6 will be measured before, 24, 48 hours after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse effects</measure>
    <time_frame>Up to 48 hours after the procedure</time_frame>
    <description>Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Chest Trauma</condition>
  <arm_group>
    <arm_group_label>Group A (ESP block)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (TEA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ESP block</intervention_name>
    <description>A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM.</description>
    <arm_group_label>Group A (ESP block)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TEA</intervention_name>
    <description>Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space.</description>
    <arm_group_label>Group B (TEA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter insertion</intervention_name>
    <description>After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.</description>
    <arm_group_label>Group A (ESP block)</arm_group_label>
    <arm_group_label>Group B (TEA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours</description>
    <arm_group_label>Group A (ESP block)</arm_group_label>
    <arm_group_label>Group B (TEA)</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) status: 1 or 2 .&#xD;
&#xD;
          -  Blunt chest trauma.&#xD;
&#xD;
          -  Multiple rib fractures.&#xD;
&#xD;
          -  Flail chest.&#xD;
&#xD;
          -  Lung contusions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bilateral chest trauma.&#xD;
&#xD;
          -  Intubated patients.&#xD;
&#xD;
          -  Other peripheral or abdominal injuries.&#xD;
&#xD;
          -  Traumatic brain injury, altered mental status or un-cooperative patients.&#xD;
&#xD;
          -  Acute spine fractures or pre-existing spine deformity.&#xD;
&#xD;
          -  Unstable hemodynamics.&#xD;
&#xD;
          -  Sensitivity to local anesthetic drugs.&#xD;
&#xD;
          -  Coagulation abnormalities.&#xD;
&#xD;
          -  Infection at the site of procedure.&#xD;
&#xD;
          -  Significant cardiac or respiratory dysfunction, hepatic or renal impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh M El-Sherbiny, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University Hospitals</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35511</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>
  <reference>
    <citation>Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08.</citation>
    <PMID>24368355</PMID>
  </reference>
  <reference>
    <citation>Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.</citation>
    <PMID>27533913</PMID>
  </reference>
  <reference>
    <citation>Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.</citation>
    <PMID>30052229</PMID>
  </reference>
  <reference>
    <citation>Singh S, Jacob M, Hasnain S, Krishnakumar M. Comparison between continuous thoracic epidural block and continuous thoracic paravertebral block in the management of thoracic trauma. Med J Armed Forces India. 2017 Apr;73(2):146-151. doi: 10.1016/j.mjafi.2016.11.005. Epub 2016 Dec 24.</citation>
    <PMID>28924315</PMID>
  </reference>
  <reference>
    <citation>Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.</citation>
    <PMID>29102405</PMID>
  </reference>
  <reference>
    <citation>Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.</citation>
    <PMID>29766081</PMID>
  </reference>
  <reference>
    <citation>Yeh DD, Kutcher ME, Knudson MM, Tang JF. Epidural analgesia for blunt thoracic injury--which patients benefit most? Injury. 2012 Oct;43(10):1667-71. doi: 10.1016/j.injury.2012.05.022. Epub 2012 Jun 16.</citation>
    <PMID>22704784</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Fathy</investigator_full_name>
    <investigator_title>Lecturer of anesthesia, ICU &amp; pain management; Faculty of Medicine</investigator_title>
  </responsible_party>
  <keyword>Erector spinae plane block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Thoracic Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT03797079
org study id: ESP Block for Chest Trauma
nct id: NCT03797079
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Rib fractures are very common as a consequence of blunt chest trauma which is associated with
      severe pain, morbidity and mortality. The key to managing these patients is prompt and
      effective analgesia, early mobilization, respiratory support, with chest physiotherapy. The
      aim of this study is to compare and evaluate the differences between either continuous
      erector spinae plane (ESP) block, or thoracic epidural analgesia (TEA) as analgesic
      modalities in patients with chest trauma. It is hypothesized that ESP block will be
      comparable to TEA as a promising effective analgesic alternative with fewer side effects.
Trauma is a major cause of morbidity and mortality worldwide as a leading cause of death. Rib
      fractures are very common and are detected in at least 10% of all injured patients, the
      majority of which are as a consequence of blunt chest trauma. Chest trauma are associated
      with severe pain, morbidity and mortality, as it contributes to atelectasis, lobar collapse,
      pneumonia, effusion, aspiration, acute respiratory distress syndrome pulmonary embolism,
      increased intensive care admissions, and poor overall clinical outcomes. Trauma is associated
      with release of cytokines, which contribute to the development of hemodynamic instability and
      metabolic derangement, which can worsen prognosis. The efficacy of utilizing different
      modalities for analgesia in controlling extent of tissue damage can be compared by measuring
      these cytokines levels. Multiple analgesic modalities have been used in these patients with
      chest trauma, such as oral analgesics, intravenous opioids, patient-controlled opioid
      analgesia, inter-pleural blocks, intercostal blocks, serratus plane blocks, paravertebral
      blocks, and TEA. In trauma patients with rib fractures, retrospective studies showed that TEA
      has become the gold standard of care, while ultrasound-guided paravertebral and serratus
      plane blocks are possible alternatives. However, no single best analgesic modality could be
      recommended or established, based on available data in this population, as no meta-analysis
      on this topic has yet been completed. Ultrasound has been the fundamental tool for a
      significant improvement in the progress of regional analgesic techniques of inter-fascial
      chest wall blocks, allowing their description and introduction into clinical practice.
      Ultrasound-guided ESP block is a new technique that has been recently described in the
      control of both chronic neuropathic pain as well as acute postsurgical or post-traumatic pain
      of the chest wall. The ESP block holds promise as a simple, easy, fast and safe technique for
      thoracic analgesia in the context of pain associated with chest trauma.

      Aim of the Study:

      The aim of this study is to assess the quality of pain relief and improvement of pulmonary
      function in patients with chest trauma receiving either continuous ESP block or TEA by
      comparing and evaluating the differences between the two techniques. It is hypothesized that
      ESP block will be comparable to TEA as a promising effective analgesic alternative with fewer
      side effects.

      Sample Size Calculation:

      The literature available on ESP block is limited to some sporadic case reports and
      editorials. Hence, this clinical trial will be conducted on 50 patients and post hoc analysis
      will be performed using pain scores obtained from the present study with an α (type I error)
      = 0.05 and β (type II error) = 0.2 (power = 80%).

      Methods:

      The study will be conducted in Mansoura Emergency Hospital on fifty patients admitted with
      chest trauma. They will be randomly assigned to two equal groups (ESP group and TEA group)
      according to computer-generated table of random numbers using the permuted block
      randomization method. The group allocation will be concealed in sequentially numbered, sealed
      opaque envelopes which will be opened only after obtaining the written informed consent.
      Patient demographic data including age, sex, body weight, and status of American Society of
      Anesthesiologists (ASA) will be recorded. A written informed consent will be obtained from
      all study subjects after ensuring confidentiality. The study protocol will be explained to
      all patients after enrollment into the study. In both groups, catheter-based analgesia will
      be performed with a bolus dose of bupivacaine followed by a continuous infusion for 48 hours.
      Later on, the catheters will be removed, and the pain management will be switched to parental
      or oral analgesics.

      Statistical Methods:

      The collected data will be coded, processed, and analyzed using Statistical Package for the
      Social Sciences (SPSS) program (version 22) for Windows. Normality of numerical data
      distribution will be tested by Shapiro-Wilk test. Continuous data of normal distribution will
      be presented as mean ± standard deviation, and compared with the unpaired student's t test.
      Non-normally distributed data will be presented as median (range), and compared with the
      Mann-Whitney U test. Repeated measures analysis of variance (ANOVA) test will be used for
      comparisons within the same group. Categorical data will be presented as number (percentage),
      and compared with the Chi-square test. All data will be considered statistically significant
      if P value is ≤ 0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, double blind study
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
measure: Improvement in pain scores by Visual analogue scale (VAS)
time frame: Up to 48 hours after the procedure
description: VAS score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) will be assessed every two hours for 48 hours after the procedure.
measure: Total analgesic requirements of fentanyl
time frame: Up to 48 hours after the procedure
description: The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 48 hours.
measure: First analgesic request
time frame: Up to 48 hours after the procedure
description: The time of the first analgesic request for fentanyl will be recorded.
measure: Changes in heart rate (HR)
time frame: Up to 48 hours after the procedure
description: HR will be recorded every two hours for 48 hours after the procedure.
measure: Changes in mean arterial blood pressure (MAP)
time frame: Up to 48 hours after the procedure
description: MAP will be recorded every two hours for 48 hours after the procedure.
measure: Improvement in forced expiratory volume in one second (FEV1)
time frame: Up to 48 hours after the procedure
description: FEV1 will be assessed by spirometry before and 48 hours after the procedure.
measure: Improvement in forced vital capacity (FVC)
time frame: Up to 48 hours after the procedure
description: FVC will be assessed by spirometry before and 48 hours after the procedure.
measure: Improvement in forced expiratory flow (FEF 25-75%)
time frame: Up to 48 hours after the procedure
description: FEF 25-75% will be assessed by spirometry before and 48 hours after the procedure.
measure: Improvement in the level of tumor necrosis factor alpha (TNF-α)
time frame: Up to 48 hours after the procedure
description: TNF-α will be measured before, 24, 48 hours after the procedure.
measure: Improvement in the level of interleukin 6 (IL-6)
time frame: Up to 48 hours after the procedure
description: IL-6 will be measured before, 24, 48 hours after the procedure.
measure: Incidence of adverse effects
time frame: Up to 48 hours after the procedure
description: Any adverse effects like pneumothorax, respiratory depression, nausea, vomiting, hematoma, or allergic reactions will be recorded.
arm group label: Group A (ESP block)
arm group type: Active Comparator
description: Ultrasound-guided ESP block will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.
arm group label: Group B (TEA)
arm group type: Active Comparator
description: TEA will be performed under strict aseptic precautions with patient in the sitting position. Catheter insertion will be performed and bupivacaine will be administered.
intervention type: Procedure
intervention name: ESP block
description: A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM.
arm group label: Group A (ESP block)
intervention type: Procedure
intervention name: TEA
description: Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space.
arm group label: Group B (TEA)
intervention type: Device
intervention name: Catheter insertion
description: After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.
arm group label: Group A (ESP block)
arm group label: Group B (TEA)
intervention type: Drug
intervention name: Bupivacaine
description: After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours
arm group label: Group A (ESP block)
arm group label: Group B (TEA)
other name: Marcaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sameh M El-Sherbiny, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Mansoura University
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
citation: Gage A, Rivara F, Wang J, Jurkovich GJ, Arbabi S. The effect of epidural placement in patients after blunt thoracic trauma. J Trauma Acute Care Surg. 2014 Jan;76(1):39-45; discussion 45-6. doi: 10.1097/TA.0b013e3182ab1b08.
PMID: 24368355
citation: Galvagno SM Jr, Smith CE, Varon AJ, Hasenboehler EA, Sultan S, Shaefer G, To KB, Fox AD, Alley DE, Ditillo M, Joseph BA, Robinson BR, Haut ER. Pain management for blunt thoracic trauma: A joint practice management guideline from the Eastern Association for the Surgery of Trauma and Trauma Anesthesiology Society. J Trauma Acute Care Surg. 2016 Nov;81(5):936-951. doi: 10.1097/TA.0000000000001209.
PMID: 27533913
citation: Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PMID: 30052229
citation: Singh S, Jacob M, Hasnain S, Krishnakumar M. Comparison between continuous thoracic epidural block and continuous thoracic paravertebral block in the management of thoracic trauma. Med J Armed Forces India. 2017 Apr;73(2):146-151. doi: 10.1016/j.mjafi.2016.11.005. Epub 2016 Dec 24.
PMID: 28924315
citation: Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.
PMID: 29102405
citation: Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
PMID: 29766081
citation: Yeh DD, Kutcher ME, Knudson MM, Tang JF. Epidural analgesia for blunt thoracic injury--which patients benefit most? Injury. 2012 Oct;43(10):1667-71. doi: 10.1016/j.injury.2012.05.022. Epub 2012 Jun 16.
PMID: 22704784
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Fathy
investigator title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
mesh term: Wounds and Injuries
mesh term: Thoracic Injuries
mesh term: Bupivacaine
sharing ipd: No