<?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>IRCT201410137984N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-26</date_registration>
      <primary_sponsor>Vice chancellor for research, Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of adding magnesium to bupivacaine for femoral nerve block on postoperative pain in patients undergoing knee and femoral orthopedic operations</public_title>
      <acronym></acronym>
      <scientific_title>The effect of adding magnesium to bupivacaine for femoral nerve block on postoperative pain in patients undergoing knee and femoral orthopedic operations</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8433</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Postoperative Analgesia. Condition 2: Postoperative Analgesia.</hc_freetext>
      <i_freetext>Intervention 1: After the written informed consent from the patients  in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In first group30 patient with femur or knee surgery by spinal anesthesia 19.6cc bupivacaine 0.2% with 0.4cc magnesium sulfate 50%(200 mg)perform injection. According to the questionnaire in all of  patients  the major variables such as VAS ,sedation score,bromage score before block  and just after block  and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs. Intervention 2: After the written informed consent from the patients  in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In second group30 patient with femur or knee surgery by spinal anesthesia with 20cc bupivacaine 0.2% perform injection. According to the questionnaire in all of  patients  the major variables such as VAS ,sedation score,bromage score before block  and just after block  and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs.</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. Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Interventional pain operating room, 4th floor, Hazrat e Rasoul hospital, Nyayesh St., Satarkhan st., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2107</telephone>
        <email>farimani@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4th floor, Rasoul akram hospital, Nyayesh st., Satarkhan st., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2107</telephone>
        <email>farimani@tums.ac.ir</email>
        <affiliation>Hazrat Rasoul akram hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients' consent؛ No usage of anti- coagulant drugs؛ No infection at the site of injection؛ Age between 18 and 65 years old؛ ASA1&amp;2&#13;
  Exclusion criteria: Patient refusal( no consent of the patients)؛ Surgery on PCL؛ Any complication due to injection or drugs, Calcium channel blocker usage, History of advanced renal disease؛ Allergy to drugs and Central or peripheral neurologic disorders.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52</hc_code>
      <hc_code>T84.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</hc_keyword>
      <hc_keyword>Pain due to orthopedic internal implantation, fixation and other procedure</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>After the written informed consent from the patients  in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In first group30 patient with femur or knee surgery by spinal anesthesia 19.6cc bupivacaine 0.2% with 0.4cc magnesium sulfate 50%(200 mg)perform injection. According to the questionnaire in all of  patients  the major variables such as VAS ,sedation score,bromage score before block  and just after block  and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs.</i_keyword>
      <i_keyword>After the written informed consent from the patients  in the study the femoral block perform with guide of sonography and nerve stimulator on the lateral side of femoral artery below the inguinal ligament for confirming the nerve location. In second group30 patient with femur or knee surgery by spinal anesthesia with 20cc bupivacaine 0.2% perform injection. According to the questionnaire in all of  patients  the major variables such as VAS ,sedation score,bromage score before block  and just after block  and in times 3-6-12 after that the same criteria with the consumption of any other analgesic and patient satisfication will evaluate and record. For patients in this study questionnaire fille out by someone who does not know the nature of the injected drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: before block-just after block-3-6-12 hours after block. Method of measurement: visual analog scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sedation. Timepoint: Just after block and 3-6-12 hours after block. Method of measurement: Sedation score.</sec_outcome>
      <sec_outcome>Satisfication. Timepoint: Just after block and 3-6-12 houres  after block. Method of measurement: Questionnare.</sec_outcome>
      <sec_outcome>Additional requirement for opioid analgesics. Timepoint: Just after block and 3-6-12 hours after block. Method of measurement: Total dosage of injected additional analgesic  in miligram.</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>Vice chancellor for research, Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-24</approval_date>
        <contact_name>Ethic committee of Iran university of medical sciences</contact_name>
        <contact_address>Ethic committee ,Iran university of medical sciences, Hemmat Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
