<?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>IRCT2016020126315N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences Vice chancellor for research</primary_sponsor>
      <public_title>Evaluation of the success rate of hematoma block with and without ultrasound-guide in pain control of distal radial fracture reduction in patients presenting to the emergency department</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the success rate of hematoma block with and without ultrasound-guide in pain control of distal radial fracture reduction in patients presenting to the emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Diagnostic, Other design features: In this study, randomization is made with random numbers table in patients above 18 years with acute distal radius fracture.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fracture of the distal radius.</hc_freetext>
      <i_freetext>Intervention 1: In A group, hematoma block without ultrasound guidance, after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method. Intervention 2: In B group, hematoma block with ultrasound guidance, at first we identify hematoma with ultrasound and after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Assiyeh Baradaran Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Edalatian emergency departmet, Imam Reza Hospital, Ibn Sina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3852 5312</telephone>
        <email>assibfard@gmail.com; baradaranfa921@mums.ac.ir; pishbine@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Elham Pishbin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Office of the department of emergency medicine, Edalatian emergency department, Imam Reza hospital, Ibn Sina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3852 5312</telephone>
        <email>pishbine@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients with acute fractures of the distal forearm ASA class I and II and among people over the age of 18 years&#13;
Exclusion criteria: Older fractures than 12 hours; Open fractures due to technical problem; Patients with a history of drug abuse or any kind of debilitating CNS and respiratory medications</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S52.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of lower end of radius</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In A group, hematoma block without ultrasound guidance, after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.</i_keyword>
      <i_keyword>In B group, hematoma block with ultrasound guidance, at first we identify hematoma with ultrasound and after disinfection, lidocaine 1% is injected in the center of the hematoma and around ulnar styloid with Barbutazh technique. Ten minutes after anesthesia block is proved by asking the patient and the pressure at the site of block then reduction is performed. Injection and reduction are done by research supervisor. Pain during hematoma block and reduction, is measured on the base of visual analogue scale by research fellow who is unaware about the method of choosing the site of injection. The method of evaluation is explained to the patient before and after injection. Patient satisfaction about analgesia is measured at the time of block and 30 minutes after according to the method as described method.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: before block, 30 minutes after reduction. Method of measurement: visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Reducton time. Timepoint: reduction time. Method of measurement: minute.</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>Mashhad University of Medical Sciences Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-10</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Pardis of  Ferdowsi  University, Azadi squrare, Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
