<?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>IRCT20110103005536N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-24</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of adding dexamethasone to lidocaine in digital block</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of adding dexamethasone to lidocaine in digital block in patients referred to the operating room of AJA 501 hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51047</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly assigned by sampling method and using black and white cards are divided between the two groups (30 people in each group), so that patients with black card are assigned to group one, and patients with white card are assigned to group two. Given and this process is repeated again, Blinding description: In this study, neither the patient nor the collector knew how the samples were distributed. The obtained information is then statistically analyzed by the person in charge of statistical work who does not know how the patients are distributed.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Digital nerve block.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In one group,depending on the color of the patient's black or white card, participating in the project of 3 cc of 2% lidocaine plus 1 cc (equivalent to 4 mg) of dexamethasone, a digital finger block is performed and 10 minutes after the block Surgery is started by a surgeon. Intervention 2: Intervention group:In one group,depending on the color of the patient's black or white card, participating in the project, 3 cc of 2% lidocaine plus 1 cc of distilled water will perform a digital finger block and 10 minutes after the surgical block, the surgeon will start the operation.</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 can be shared after being unidentified

When:
Start the access period after printing the results

To whom:
All researchers and colleagues in this field

Conditions:
For therapeutic and research purposes and by mentioning the names of the authors of the article

Where to obtain:
Dr. Mohammadreza rafiei

How to obtain:
Send email to Dr. Mohammad Reza Rafiei and receive data and documents if needed in the shortest time

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamadreza Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemadzadeh street. West fatemi</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158177365</zip>
        <telephone>+98 21 8802 8933</telephone>
        <email>mo_rafiei@armyums.ac.ir</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamadreza Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Etemadzadeh St. West Fatemi Ave.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158177365</zip>
        <telephone>+98 21 8802 8933</telephone>
        <email>mo_rafiei@armyums.ac.ir</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients 20 to 60 years
ASA |</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of allergy to local anesthetic
pregnancy
People with a history of diabetes or uncontrolled liver and kidney disease
People with hemodynamic instability
people with history of peptic ulser
People on long-term treatment with corticosteroids.</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In one group,depending on the color of the patient's black or white card, participating in the project of 3 cc of 2% lidocaine plus 1 cc (equivalent to 4 mg) of dexamethasone, a digital finger block is performed and 10 minutes after the block Surgery is started by a surgeon</i_keyword>
      <i_keyword>Intervention group:In one group,depending on the color of the patient's black or white card, participating in the project, 3 cc of 2% lidocaine plus 1 cc of distilled water will perform a digital finger block and 10 minutes after the surgical block, the surgeon will start the operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>FPP (Free Pain Period). Timepoint: When the patient requests an analgesic. Method of measurement: Duration of the patient's analgesic period in hours.</prim_outcome>
      <prim_outcome>Intensity of pain. Timepoint: During the intervention. Method of measurement: According to the instruction given to all patients on how to express pain intensity according to the equivalent of visual equivalent (Visual Analogue Scale) through a 100 mm ruler, patients express their pain intensity as grade I≤30 (mild pain) and grade &lt;30 II≤70  (Moderate pain)  Grade III is divided into &lt;70 (severe pain).</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-08-01</approval_date>
        <contact_name>Ethics committee of aja univercity of medical sciences</contact_name>
        <contact_address>Etemadzadeh St. , West Fatemi Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
