<?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>IRCT20230204057318N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Interscalene block with &amp; without superficial  cervical block</public_title>
      <acronym></acronym>
      <scientific_title>Efficacy comparison between interscalene block with &amp; without superficial  cervical block for anesthesia in clavicle surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Creating a random sequence using a simple randomization method using 120 cards (60 cards for each group) that are placed inside opaque sealed envelopes and will be shuffled by the patients before choosing, Blinding description: The people responsible for creating a random sequence from the research team will not be responsible for examining the dependent variable. (The study will be blind.)
Also, the data analyst will not know about the coding of the examined groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Clavicle fracture surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After placing the patient in a suitable position, the interscalene block will be performed by experienced anesthesiologists, all of whom are trained in regional anesthesia. To perform each interscalene block, 20 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000  epinephrine (Daroupash Co.), plus 4 ml of 0.5% bupivacaine (AstraZeneca Co.) will be used. An ultrasonic guide (S-Nerve Sonosite) with a linear probe of 6-15 MHz will be used to perform the block. Intervention 2: Control group: in the control group, in addition to performing the interscalene block method as described, superficial cervical plexus block with 10 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000 epinephrine (Daroupakhsh Co.) plus 2 ml of 0.5%  bupivacaine (AstraZeneca  Co.) will be used. This block will be performed under ultrasonic guidance (S-Nerve Sonosite) with a 6-15 MHz linear probe.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Afsaneh Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen Street, Velenjak, Chamran Highway,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2990 8040</telephone>
        <email>a.habibi85@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Afsaneh Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen Street, Velenjak, Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 2990 8040</telephone>
        <email>a.habibi85@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients weights less than 80 kg
Age between 18 to 60 years
Normal neuromotor and sensory functions
Consent to the operation and performing the anesthetic procedure</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Persistent treatment or abuse of narcotics, alcohol or other addictive drugs
Contraindications of nerve blocks (Local infection, coagulopathy and sensitivity to anesthetics)
Presence of mental disorders, restrictive or obstructive pulmonary diseases
Pregnancy
Consuming beta blockers or heart rate below 50</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S42.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of clavicle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After placing the patient in a suitable position, the interscalene block will be performed by experienced anesthesiologists, all of whom are trained in regional anesthesia. To perform each interscalene block, 20 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000  epinephrine (Daroupash Co.), plus 4 ml of 0.5% bupivacaine (AstraZeneca Co.) will be used. An ultrasonic guide (S-Nerve Sonosite) with a linear probe of 6-15 MHz will be used to perform the block.</i_keyword>
      <i_keyword>Control group: in the control group, in addition to performing the interscalene block method as described, superficial cervical plexus block with 10 ml of 1.5% lidocaine (Caspin Co.) along with 1 ml of 8.4% bicarbonate (Caspin Co.) and 1:200,000 epinephrine (Daroupakhsh Co.) plus 2 ml of 0.5%  bupivacaine (AstraZeneca  Co.) will be used. This block will be performed under ultrasonic guidance (S-Nerve Sonosite) with a 6-15 MHz linear probe.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Need to induce general anesthesia for surgery. Timepoint: During surgery. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postoperative pain score in the recovery room. Timepoint: From the entrance to the recovery room until discharge time from the recovery room. Method of measurement: Visual analogue scale.</sec_outcome>
      <sec_outcome>The onset of sensory block. Timepoint: From the end of the nerve block procedure until the beginning of surgery. Method of measurement: Chronometer (Minute).</sec_outcome>
      <sec_outcome>The amount of narcotics used in recovery room. Timepoint: From the entrance to the recovery room until discharge time from the recovery room. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>Need for sedation during surgery. Timepoint: During surgery. Method of measurement: Observation.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-25</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
