<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/NCT04446403</url>
  </required_header>
  <id_info>
    <org_study_id>S-10-2019</org_study_id>
    <nct_id>NCT04446403</nct_id>
  </id_info>
  <brief_title>Circumflex Nerve Blocks Versus Posterior Cord Nerve Blocks in Shoulder Arthroscopy</brief_title>
  <official_title>Analgesic Effect of Ultrasound Guided Combined (Suprascapular and Circumflex Nerve Blocks ) Versus (Suprascapular Nerve and Posterior Cord Nerve Blocks at Infraclavicular Level ) During Shoulder Arthroscopy : A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bassant M. Abdelhamid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</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>
      Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the&#xD;
      interscalene approach to the brachial plexus has been employed to manage postoperative pain&#xD;
      following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular&#xD;
      nerve block (SSNB) was combined with block of the circumflex nerve which comes from the&#xD;
      posterior cord of the brachial plexus that usually gives also upper subscapular,&#xD;
      thoracodorsal, lower subscapular and radial nerves.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined&#xD;
      suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord&#xD;
      blocks at infraclavicular level .&#xD;
&#xD;
      Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and&#xD;
      scheduled for shoulder surgeries will be included in the study. Patients will be randomly&#xD;
      allocated using computer-generated table into one of two groups:&#xD;
&#xD;
        -  Group circumflex → will undergo ultrasound guided SSN+circumflex.&#xD;
&#xD;
        -  Group posterior cord → will undergo ultrasound guided SSN+posterior cord.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of the first postoperative analgesic request</measure>
    <time_frame>12 hours postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue score</measure>
    <time_frame>12 hours postoperative</time_frame>
    <description>visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total morphine consumption</measure>
    <time_frame>12 hours postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>circumflex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will undergo ultrasound guided SSN+circumflex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>posterior cord</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will undergo ultrasound guided SSN+circumflex</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suprascapular Nerve Block</intervention_name>
    <description>The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .</description>
    <arm_group_label>circumflex</arm_group_label>
    <arm_group_label>posterior cord</arm_group_label>
    <other_name>SSN</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Axillary Nerve Block</intervention_name>
    <description>Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.</description>
    <arm_group_label>circumflex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>posterior cord block</intervention_name>
    <description>Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.</description>
    <arm_group_label>posterior cord</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.</description>
    <arm_group_label>circumflex</arm_group_label>
    <arm_group_label>posterior cord</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I-II.-III&#xD;
&#xD;
          -  Undergoing shoulder arthroscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Known allergy to local anesthetics&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Mohamed Abd-Elraouf Nasr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Zaghloul</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohsen Waheb</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Zaghloul</last_name>
    <phone>002-01001839591</phone>
    <email>a_zaghloul2000@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohsen Waheb</last_name>
    <phone>002-01001525602</phone>
    <email>Mohsen.mwaheb@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Anesthesia Department</name>
      <address>
        <city>Cairo</city>
        <zip>1772</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bassant abdelhamid</last_name>
      <phone>01224254012</phone>
      <email>bassantmohamed197@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00.</citation>
    <PMID>18165599</PMID>
  </reference>
  <reference>
    <citation>Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.</citation>
    <PMID>18020078</PMID>
  </reference>
  <reference>
    <citation>Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1.</citation>
    <PMID>28258838</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Bassant M. Abdelhamid</investigator_full_name>
    <investigator_title>associate professor</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT04446403
org study id: S-10-2019
nct id: NCT04446403
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Shoulder arthroscopy is associated with severe postoperative pain. Traditionally, the
      interscalene approach to the brachial plexus has been employed to manage postoperative pain
      following shoulder surgery.To provide more complete shoulder joint analgesia, suprascabular
      nerve block (SSNB) was combined with block of the circumflex nerve which comes from the
      posterior cord of the brachial plexus that usually gives also upper subscapular,
      thoracodorsal, lower subscapular and radial nerves.
Aim of the work is to compare postoperative analgesic effect of ultrasound guided combined
      suprascapular and circumflex nerve blocks versus suprascapular nerve and posterior cord
      blocks at infraclavicular level .

      Thirty four patients aged from 18-70 years old, with ASA physical status I-II-III and
      scheduled for shoulder surgeries will be included in the study. Patients will be randomly
      allocated using computer-generated table into one of two groups:

        -  Group circumflex → will undergo ultrasound guided SSN+circumflex.

        -  Group posterior cord → will undergo ultrasound guided SSN+posterior cord.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Time of the first postoperative analgesic request
time frame: 12 hours postoperative
measure: Visual analogue score
time frame: 12 hours postoperative
description: visual analog scale (VAS) ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain) and verbal pain scale (VPS )ranging from 0 to 3 (0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain).
measure: Total morphine consumption
time frame: 12 hours postoperative
arm group label: circumflex
arm group type: Experimental
description: patients will undergo ultrasound guided SSN+circumflex
arm group label: posterior cord
arm group type: Experimental
description: patients will undergo ultrasound guided SSN+circumflex
intervention type: Procedure
intervention name: Suprascapular Nerve Block
description: The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
arm group label: circumflex
arm group label: posterior cord
other name: SSN
intervention type: Procedure
intervention name: Axillary Nerve Block
description: Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
arm group label: circumflex
intervention type: Procedure
intervention name: posterior cord block
description: Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.
arm group label: posterior cord
intervention type: Procedure
intervention name: General anesthesia
description: General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
arm group label: circumflex
arm group label: posterior cord
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mohamed Abd-Elraouf Nasr
role: Principal Investigator
affiliation: Cairo University
last name: Ahmed Zaghloul
role: Study Director
affiliation: Cairo University
last name: Mohsen Waheb
role: Study Director
affiliation: Cairo University
last name: Ahmed Zaghloul
phone: 002-01001839591
email: a_zaghloul2000@yahoo.com
last name: Mohsen Waheb
phone: 002-01001525602
email: Mohsen.mwaheb@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Axelsson K, Gupta A, Johanzon E, Berg E, Ekback G, Rawal N, Enstrom P, Nordensson U. Intraarticular administration of ketorolac, morphine, and ropivacaine combined with intraarticular patient-controlled regional analgesia for pain relief after shoulder surgery: a randomized, double-blind study. Anesth Analg. 2008 Jan;106(1):328-33, table of contents. doi: 10.1213/01.ane.0000297297.79822.00.
PMID: 18165599
citation: Price DJ. The shoulder block: a new alternative to interscalene brachial plexus blockade for the control of postoperative shoulder pain. Anaesth Intensive Care. 2007 Aug;35(4):575-81. doi: 10.1177/0310057X0703500418.
PMID: 18020078
citation: Lyons C, Herring AA. Ultrasound-guided axillary nerve block for ED incision and drainage of deltoid abscess. Am J Emerg Med. 2017 Jul;35(7):1032.e3-1032.e7. doi: 10.1016/j.ajem.2017.01.064. Epub 2017 Feb 1.
PMID: 28258838
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Bassant M. Abdelhamid
investigator title: associate professor
mesh term: Pain, Postoperative
mesh term: Anesthetics
sharing ipd: No