<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220425054655N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Pain in patients undergoing shoulder surgery using interscalene in comparison with anterior suprascapular nerve block technique</public_title>
      <acronym></acronym>
      <scientific_title>Pain in patients undergoing shoulder surgery using interscalene in comparison with anterior suprascapular nerve block technique</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63194</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Patients undergoing shoulder surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: ISB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. To perform an ISB, an ultrasound scan will be performed to identify the C5, C6, and C7 nerve roots between the scapular muscles. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated. Intervention 2: Intervention group: SSNB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. For the anterior SSNB, the nerve will follow until it separates from the brachial plexus and enters the supraclavicular cavity below the ohmoid muscle. Local anesthesia will then be applied outside the suprascapular nerve and just below the omoid muscle. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after unidentifiable individuals

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
The use of data and documents is permitted in accordance with what will be extracted from the article.

Where to obtain:
Reza AtefYekta

How to obtain:
Six months after the publication of the article, the application will be reviewed by the project manager and submitted as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Atefyekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, North Kargar St., Jalal Al-Ahmad Intersection, Opposite the Faculty of Economics, Dr. Shariati Research and Training Center</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 0008 4901</telephone>
        <email>khorsandi.rihanna@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza AtefYekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>North Kargar St., Jalal Al-Ahmad Three Ways, Opposite the Faculty of Economics, Dr. Shariati Research and Treatment Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713135</zip>
        <telephone>+98 21 0008 4901</telephone>
        <email>khorsandi.rihanna@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients undergoing atherosclerotic shoulder surgery,
People 21 years and older,
body mass index 18-35 kg / m2
Complete satisfaction from participating in the study</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are unable to express satisfaction
People who have been chronically treated for opioids
People who are allergic to the drugs under study
People with neurological defects
Patients with advanced lung disease (COPD and uncontrolled asthma)
Surgeries over 3 hours
People who have any contraindications to local anesthesia such as coagulopathy and local infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: ISB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. To perform an ISB, an ultrasound scan will be performed to identify the C5, C6, and C7 nerve roots between the scapular muscles. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. Local anesthesia will be performed in the area between the C5 and C6 nerve roots, in the gap between the scales. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated.</i_keyword>
      <i_keyword>Intervention group: SSNB local anesthesia. Intravenous access is provided and sedation is performed with midazolam (up to 2 mg) and 50 μg fentanyl if necessary. Standard monitors will be used throughout the block and supplemental oxygen will be provided. Intrascal block (ISB) and anterior suprascapular block (SSNB) will be performed under ultrasound guidance. In each group of 15 ml (75 mg) of 0.5% rupivacaine will be used to block. The anterior ISB and SSNB will be performed while the patient is in a supine position. For the anterior SSNB, the nerve will follow until it separates from the brachial plexus and enters the supraclavicular cavity below the ohmoid muscle. Local anesthesia will then be applied outside the suprascapular nerve and just below the omoid muscle. The success rate of the block in the first 30 minutes after the block will be measured by assessing the degree of sensory and motor block. General anesthesia will be performed with intravenous fentanyl up to 3 micrograms per kilogram of patient weight, propofol 2 milligrams per kilogram of body weight and atracurium 0.5 mg per kilogram of patient weight. Endotracheal tubes are also implanted for patients. Fentanyl will be used in the recovery room if necessary and its amount will be recorded. Pain will be measured by the VAS scale 16 and 24 hours after recovery recovery. The first request for analgesia, the need for analgesia in the first 24 hours after the block, patient satisfaction, and side effects will also be considered. The total number of additional analgesic prescriptions for 48 hours after surgery will also be calculated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain scoring. Timepoint: 16 and 24 hours after surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice-Chancellor in Research Affairs of Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-16</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran, the intersection of Keshavarz Boulevard and Ghods St., the headquarters of Tehran University of Medical Sciences, sixth floor, Room 605, Research and Technology Affairs Department tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
