<?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>IRCT20200402046916N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-06</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Lidocaine and a mixture of Lidocaine and Granisetron on axillary block</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of duration of analgesia in Axillary block with Lidocaine and a mixture of Lidocaine and Granistron in patients requiring lower elbow surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-12-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51268</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Simple block randomization with block size 4 and allocation ratio 1:1 (One sample was placed in the intervention group and one sample in the control group until sampling was completed) . Balanced Block Randomization method with block size 4 (With random sequence in the block) and one-to-one allocation was used to place patients in the two groups. The randomization unit was individual.
Codes assigned to patients in both groups were kept in sealed envelopes and provided to the ward secretary. Patients and health care providers did not know about these codes, Blinding description: Participants and health providers will be blinded to the intervention.
Codes assigned to patients in both groups were kept in sealed envelopes and provided to the ward secretary. Patients and health care providers did not know about these codes.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients require lower elbow surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution and 2 mg of Granistron is injected into patients simultaneously. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company. Intervention 2: Control group:  5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution is injected. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pardis Vakili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahwaz Jundishapur University of Medical Sciences and Health Services, Golestan Boulevard, Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135539345</zip>
        <telephone>+98 61 3222 2922</telephone>
        <email>vakilipardis@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Bozar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahvaz Jundishapur University of Medical Sciences, Golestan Boulevard, Ahwaz</address>
        <city>Ahwaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135539345</zip>
        <telephone>+98 21 8770 5402</telephone>
        <email>majid.bozar91medical@gmail.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are candidates for elbow and below elbow surgery
Patients between the ages of 18-58 years
Patients whose level of consciousness is above 14 according to the Glasgow standard</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>58 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who are allergic to Lidocaine and granisterone
Patients who take drugs that interact with Lidocaine and Granistron
Patients who have a lesion or infection at the injection site
Patients with a history of coagulopathy</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 - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution and 2 mg of Granistron is injected into patients simultaneously. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company.</i_keyword>
      <i_keyword>Control group:  5 mg / kg Lidocaine 0.5% is diluted with 0.9% normal saline to 40 cc. After impregnating the syringe with epinephrine, 40 cc of Lidocaine solution is injected. Axillary block is performed by ultrasonography with linear transducer using short-axis view with in-plane technique. The drugs are manufactured by Caspian Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The onset of sensory block. Timepoint: The onset of sensory block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia. Method of measurement: By examining and the PIN PRINK test.</prim_outcome>
      <prim_outcome>The onset of motor block. Timepoint: The onset of motor block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia. Method of measurement: Examination and the patient's ability in adduction flexion and finger extension.</prim_outcome>
      <prim_outcome>The duration of sensory  block. Timepoint: The duration of sensory block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia. Method of measurement: By examination and PIN PRINK test.</prim_outcome>
      <prim_outcome>The duration of motor block. Timepoint: The duration of motor block will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia. Method of measurement: Examination and the patient's ability in adduction flexion and finger extension.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: The pain score will be measured at 6 and 12 hours after the intervention and also at the time of the first need for analgesia. Method of measurement: By interviewing and the Numeric Rating Scale system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after. Method of measurement: Measuring patient's blood pressure by monitoring and a Sphygmomanometer.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after. Method of measurement: Measuring the patient's heart rate by monitoring and pulse counting.</sec_outcome>
      <sec_outcome>Respiration. Timepoint: Before the intervention, every 10 minutes during the intervention and 2 and 6 hours after. Method of measurement: Measuring the patient's respiration by monitoring, using the number of breaths per minute.</sec_outcome>
      <sec_outcome>Time for taking analgesia. Timepoint: 6 and 12 hours after the intervention. Method of measurement: Based on pain scores, analgesic is injected in a pain score of 6 or more.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-21</approval_date>
        <contact_name>Ethics Committee of Ahwaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Jundishapur University of Medical Sciences, Golestan highway, Ahwaz Ahwaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
