<?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>IRCT20120814010599N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-24</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of supra inguinal fascia iliaca block with infra inguinal fascia iliaca block on pain control</public_title>
      <acronym></acronym>
      <scientific_title>Comparison between ultrasound guided supra inguinal fascia iliaca block with infra inguinal fascia iliaca block for post operative pain management in intertrochanteric femour fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients, using random allocation software, were randomly divided into supra inguinal fascia iliaca block and infra inguinal fascia iliaca block groups.  By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers, Blinding description: The patient and the statistical analyzer were unaware that the patient was exposed to the supra inguinal fascia iliaca block and  infra inguinal fascia iliaca block methods. Supra Inguinal Fascia iliaca and Infra Inguinal Fascia iliaca block will be performed by an anesthesiologist in the operating room before that the operation was finished under general anesthesia, i.e. the blocks are done when the patients are unconscious. The groups are provided to the statistical analyzer in the form of codes A and B for analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: To perform a supra-inguinal block, the patient is placed in the supine position under the ultrasound guide. The linear prop is placed transversely above the inguinal ligament and parallel to it. 40 cc of ropivacaine 0.2% (made by Cobel company) is injected between the iliac fascia and the iliac muscle. For patients, an intravenous pain control pump containing 2 gr of Apotel (made by Cobel company) and 60 mg of ketorolac (Iranhormone company) with a continuous flow of 6 cc is placed. Intervention 2: Control group: To perform a infra-inguinal block, the patient is placed in the supine position under the ultrasound guide. The linear prop is placed transversely below the inguinal ligament and parallel to it. 40 cc of ropivacaine 0.2% (made by Cobel company) is injected between the iliac fascia and the iliac muscle. For patients, an intravenous pain control pump containing 2 gr of Apotel (made by Cobel company) and 60 mg of ketorolac (Iranhormone company) with a continuous flow of 6 cc is placed.</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 further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Poupak Rahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 6650 9059</telephone>
        <email>p-rahimzadeh@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poupak Rahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 6650 9059</telephone>
        <email>p-rahimzadeh@tums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 55-75 years old who are candidates for elective surgery for intra trochanteric femoral fracture
ASA 1 and 2</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ASA  3 and 4
Patients candidates for emergency surgery (non-elective)
History of ropivacaine allergy
Liver and kidney problems
Body mass index  greater than 40
Coagulation disorders
Receive analgesic in the last 24 hours
Drug addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified</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: To perform a supra-inguinal block, the patient is placed in the supine position under the ultrasound guide. The linear prop is placed transversely above the inguinal ligament and parallel to it. 40 cc of ropivacaine 0.2% (made by Cobel company) is injected between the iliac fascia and the iliac muscle. For patients, an intravenous pain control pump containing 2 gr of Apotel (made by Cobel company) and 60 mg of ketorolac (Iranhormone company) with a continuous flow of 6 cc is placed.</i_keyword>
      <i_keyword>Control group: To perform a infra-inguinal block, the patient is placed in the supine position under the ultrasound guide. The linear prop is placed transversely below the inguinal ligament and parallel to it. 40 cc of ropivacaine 0.2% (made by Cobel company) is injected between the iliac fascia and the iliac muscle. For patients, an intravenous pain control pump containing 2 gr of Apotel (made by Cobel company) and 60 mg of ketorolac (Iranhormone company) with a continuous flow of 6 cc is placed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 0-1-4-8-16-24 hours after surgery. Method of measurement: Visual analogue scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient satisfaction. Timepoint: 0-1-4-8-16-24 hours after surgery. Method of measurement: The tool is based on Likert as follows:poor:0,moderate:1,good:2,very good:3,excellent:4.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-10</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
