<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/NCT04483323</url>
  </required_header>
  <id_info>
    <org_study_id>33097/04/19</org_study_id>
    <nct_id>NCT04483323</nct_id>
  </id_info>
  <brief_title>Erector Spinae Plane Block Versus Intraarticular Injection for Postoperative Analgesia in Shoulder Arthroscopy</brief_title>
  <official_title>Erector Spinae Plane Block Versus Intraarticular Injection of Local Anesthetic for Postoperative Analgesia in Patients Undergoing Shoulder Arthroscopy; A Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta 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>
      To improve the outcome after surgery, effective pain control is needed. The aim of the&#xD;
      current study was to compare the efficacy of ultrasound guided erector spinae plane block&#xD;
      versus the intra articular injection of local anesthetic for post-operative analgesia in&#xD;
      patients undergoing shoulder arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sample size calculation:&#xD;
&#xD;
      Calculation of sample size was done to detect a 15% difference in the VAS score between two&#xD;
      groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of&#xD;
      the study. The number will be increased to 30 patients to avoid a 10% dropped out patients.&#xD;
&#xD;
      Statistical analysis Statistical analysis will be done by Statistical Package for the Social&#xD;
      Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with&#xD;
      Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and&#xD;
      standard deviation (SD) and will be compared by unpaired student T test. Categorical&#xD;
      variables will be presented as frequency and percentage (%) and will be analysed by the&#xD;
      Chi-square test. P value &lt; 0.05 will be considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">March 16, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The amount of total postoperative rescue analgesic consumption (mg)</measure>
    <time_frame>First 24 hours postoperative</time_frame>
    <description>Rescue analgesia in the form of diclofenac sodium 75mg intramuscularly (IM) will be given if the visual analogue scale ≥ 40</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative visual analogue scale</measure>
    <time_frame>First 24 hours postoperative</time_frame>
    <description>Visual analogue scale (VAS) for determination of intensity of the pain on scale from (0-100) where 0= no pain and 100=the worst pain.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The time to first request of rescue analgesia (hours)</measure>
    <time_frame>First 24 hours postoperative</time_frame>
    <description>Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Shoulder Arthroscopy</condition>
  <condition>Postoperative Analgesia</condition>
  <condition>Erector Spinae Plane Block</condition>
  <condition>Intraarticular Injection</condition>
  <arm_group>
    <arm_group_label>Group I: Intraarticular group ( IA )</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II: Erector Spinae Plane Block group ( ES )</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Erector Spinae Plane Block</intervention_name>
    <description>The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process.&#xD;
Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected.</description>
    <arm_group_label>Group II: Erector Spinae Plane Block group ( ES )</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intraarticular Injection</intervention_name>
    <description>Intraarticular injection of local anesthetic through the surgical port</description>
    <arm_group_label>Group I: Intraarticular group ( IA )</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I-II&#xD;
&#xD;
          -  Posted for elective shoulder arthroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Chronic use of narcotics&#xD;
&#xD;
          -  Necessity for an intra articular drain after surgery&#xD;
&#xD;
          -  Patients refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taysser M Abdelraheem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer at Tanta University Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tanta University Hospitals</name>
      <address>
        <city>Tanta</city>
        <state>ElGharbiaa</state>
        <zip>31527</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>April 4, 2021</last_update_submitted>
  <last_update_submitted_qc>April 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Taysser Mahmoud Abdalraheem</investigator_full_name>
    <investigator_title>Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_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/NCT04483323
org study id: 33097/04/19
nct id: NCT04483323
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To improve the outcome after surgery, effective pain control is needed. The aim of the
      current study was to compare the efficacy of ultrasound guided erector spinae plane block
      versus the intra articular injection of local anesthetic for post-operative analgesia in
      patients undergoing shoulder arthroscopy.
Sample size calculation:

      Calculation of sample size was done to detect a 15% difference in the VAS score between two
      groups detected that at least 27 patients were needed at an α error of 0.05 and 80 % power of
      the study. The number will be increased to 30 patients to avoid a 10% dropped out patients.

      Statistical analysis Statistical analysis will be done by Statistical Package for the Social
      Sciences (SPSS) v25 (IBM Inc., Chicago, USA). Normality of data will be checked with
      Shapiro-Wilks test and histogram. Quantitative variables will be presented as mean and
      standard deviation (SD) and will be compared by unpaired student T test. Categorical
      variables will be presented as frequency and percentage (%) and will be analysed by the
      Chi-square test. P value < 0.05 will be considered statistically significant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: The amount of total postoperative rescue analgesic consumption (mg)
time frame: First 24 hours postoperative
description: Rescue analgesia in the form of diclofenac sodium 75mg intramuscularly (IM) will be given if the visual analogue scale ≥ 40
measure: Postoperative visual analogue scale
time frame: First 24 hours postoperative
description: Visual analogue scale (VAS) for determination of intensity of the pain on scale from (0-100) where 0= no pain and 100=the worst pain.
measure: The time to first request of rescue analgesia (hours)
time frame: First 24 hours postoperative
description: Time till the first need of rescue analgesia in the form of diclofenac sodium 75mg postoperative
arm group label: Group I: Intraarticular group ( IA )
arm group type: Active Comparator
description: Patients will receive 20 ml of 0.25% bupivacaine intra-articularly through the surgical port
arm group label: Group II: Erector Spinae Plane Block group ( ES )
arm group type: Experimental
description: Patients will receive an ultrasound guided erector spinae plane block using 20 ml of 0.25% bupivacaine at the level of T2 transverse process
intervention type: Procedure
intervention name: Erector Spinae Plane Block
description: The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process.
Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected.
arm group label: Group II: Erector Spinae Plane Block group ( ES )
intervention type: Procedure
intervention name: Intraarticular Injection
description: Intraarticular injection of local anesthetic through the surgical port
arm group label: Group I: Intraarticular group ( IA )
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Taysser M Abdelraheem, MD
role: Principal Investigator
affiliation: Lecturer at Tanta University Hospitals
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Taysser Mahmoud Abdalraheem
investigator title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
mesh term: Agnosia
sharing ipd: No