<?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>IRCT20200126046268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-01</date_registration>
      <primary_sponsor>Sanandaj University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of local anesthetic injection site on the quality of intravenous block</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of local anesthetic injection site on the quality of intravenous block (bier block) in upper limb</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45345</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: From a package of 70 cards, patients choose one card randomly. The letter A for the control group (Angiocath in the distal) and the letter B for the intervention group (Angiocath in the proximal). There are 35 patients in each group. Patients are then assigned to one of the intervention and control groups. Sampling continues in two groups until the number of samples is completed. The sampling method is a double blocking, Blinding description: Patients are not aware of grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fracture of forearm. Condition 2: hand laceration.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The angiocath is placed in the proximal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed. Intervention 2: Control group: The angiocath is placed in the distal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.</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:
Data on the main outcomes of the study can be shared.

When:
One year after the publication the data will be available.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Meta-analysis is allowed on the data of this study.

Where to obtain:
Dr. Kambiz Javadzadeh Siahkalrudi, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran , Email: Kambiz51js@gmail.com

How to obtain:
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kambiz Javadzadeh Siahkalrudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Hospital, Boranaldin Hamdi Blv., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66179-83476</zip>
        <telephone>+98 87 6631 1231</telephone>
        <email>Kambiz51js@gmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahpor Shoja</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kowsar Hospital, Boranaldin Hamdi Blv., Sanandaj, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66179-83476</zip>
        <telephone>+98 87 3361 1231</telephone>
        <email>shshoja@hotmail.com</email>
        <affiliation>Sanandaj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 10 to 70 years
No drug addiction
No history of lidocaine allergy</inclusion_criteria>
      <agemin>10 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug Addiction
Alcohol or painkillers consumption before entering the operating room
Allergy to local anesthetics,
Cardiovascular disease
Use of antidepressants
Hypertension
Sseizures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S52.0</hc_code>
      <hc_code>s61.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of upper end of ulna</hc_keyword>
      <hc_keyword>Open wound of wrist and hand part, part unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The angiocath is placed in the proximal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.</i_keyword>
      <i_keyword>Control group: The angiocath is placed in the distal part of the forearm. After draining the blood of upper limb, a tourniquet will apply on the arm. 3 mg/kg lidocaine 0.5% is administered through the angiocath and then the angiocath is removed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hand sensory block. Timepoint: 5, 10, 15, 20, 25 and 30 minutes after intervention. Method of measurement: It is measured based on the complete return of sense by clinical examination as touch and stimulation by pin break.Zero- No pain,1- mild pain, 2- Moderate pain, 3- Severe pain, 4- Unbearable pain.</prim_outcome>
      <prim_outcome>Hand motor block. Timepoint: Five minutes after intervention and at the end of surgery. Method of measurement: It is scored based on the hand movement status: Zero-Unable to move any part of the limb,1-Able to move fingers, 2-Able to move the limb from the wrist area, 3-Able to move the limb from the elbow area.</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>Sanandaj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-24</approval_date>
        <contact_name>Ethics committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
