<?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>IRCT20131108015322N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of fascia iliaca block on thigh tourniquet pain in orthopedic surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of  fascia iliaca block plus popliteal block on thigh tourniquet pain in below- knee orthopedic surgery compared with spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48692</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used a simple random sampling method using a table of random numbers to generate a random sequence of patients. even numbers were considered for the peripheral nerve block group and odd numbers for the spinal anesthesia group. The researcher then touches one of the numbers in the table of random numbers and moves in the right direction of the table, recording the numbers and assigning them to two groups. Each random sequence is recorded on a card. When the eligible participants enter the study, the cards are selected in order of their sequence, Blinding description: Randomization,  assignment of patients in each group, and random selection of envelopes is done by an investigator with no involvement in the trial. The person who measures the outcomes is also kept blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>management of acute tourniquet pain during below-knee surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the patients in the control group, the method of spinal anesthesia is performed. In these patients, 15 mg of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle. Intervention 2: Intervention group: In this group, fascia iliaca and popliteal blockades are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer. For the popliteal block, 20 ml of lidocaine 1.5% + epinephrine 1:200000 is administered. For fascia iliaca block, 30 ml of the same solution is injected just below the fascia iliaca.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shideh Dabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2595</telephone>
        <email>shdabir@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shideh Dabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2595</telephone>
        <email>shdabir@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA class1 and 2
unilateral surgery</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Allergy to local anesthetics
Age&gt; 80 yrs
Coagulation disorders
Opium addiction
Infection at the block site
Previous femoral or popliteal bypass surgery
BMI ≥30
Sickle cell anemia
Tourniquet inflation time less than 60 minutes
Uncooperative patients</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In the patients in the control group, the method of spinal anesthesia is performed. In these patients, 15 mg of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle.</i_keyword>
      <i_keyword>Intervention group: In this group, fascia iliaca and popliteal blockades are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer. For the popliteal block, 20 ml of lidocaine 1.5% + epinephrine 1:200000 is administered. For fascia iliaca block, 30 ml of the same solution is injected just below the fascia iliaca.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of tourniquet pain during surgery. Timepoint: Immediately after tourniquet inflation, and then every 5 min until the end of surgery. Method of measurement: Using a 5-point verbal rating scale (VRS) consisting of; 0 =no pain, 1= mild pain, 2=moderate pain, 3= severe pain, 4=unbearable pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Block performance time. Timepoint: The time taken from the beginning to the end of the local anesthetic injection. Method of measurement: The interval between the beginning to the end of local anesthetic injection in minutes.</sec_outcome>
      <sec_outcome>Anesthetic effect time. Timepoint: Time required from the end of local anesthetic injection to achieve adequate anesthesia. Method of measurement: The interval between the end of local anesthetic injection and block success required for surgical anesthesia in minutes.</sec_outcome>
      <sec_outcome>The total doses of fentanyl and ketamine administered. Timepoint: During surgery. Method of measurement: Intravenous boluses of fentanyl (µg) or ketamine (mg) given during surgery are recorded and the total dose given for each drug is calculated.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-17</approval_date>
        <contact_name>Research Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Building No. 2, 6th floor, Office of Research Affairs, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
