<?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>IRCT20191114045435N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-17</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Quadratus and Fascin illiaca nerve blocks in acetabulum fracture surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of Quadratus lumborum and Fascin illiaca nerve blocks on intraoperative narcotic use and postoperative analgesia criteria in acetabulum fracture surgeries by Stoppa method</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acetabular fracture surgeries.</hc_freetext>
      <i_freetext>Intervention 1: first Intervention group: Fascialiaka Block Group (FIB): In the supine position, after sterilizing the operation and performing cutaneous anesthesia, 2 cc of 1% lidocaine is injected at the site of the block. To perform nerve block, a high-frequency linear probe (10-25 MHz) of the ultrasound device (S-Nerre Sonosite) is used, which is placed horizontally in the inguinal region and in-plane with a needle (22 G, 80 mm). stimuplex ultra 360 °) B Braun is injected at a rate of 0.3 ml / kg and a maximum of 30 ml of 0.5% rupivacaine (manufactured by Molteni) with direct vision between the iliac fascia and the iliopsoas muscle. Intervention 2: Second Intervention group: QL group: In the supine position, a cloth roll is placed in the lumbar spine to lift the hip into the block entry area. After sterilizing the solution and performing skin anesthesia with a 2 cc lidocaine syringe needle, a 1% high-frequency linear probe (10-25 MHz) is inserted between the Costa Margin iliac crest at the anterior axillary line. The goal is to find the three abdominal anterolateral muscles (external oblique, internal oblique, and abdominis transverse). By moving the probe towards the posterolateral and with the disappearance of the abdominis transversal muscle and its aponeurosis being identified in the axillary posterior line, the quadratus rubrum muscle can be found, which is characterized as a hypovaco area of ​​hypercoa aponeurosis. In this study, Curanasus lumburum 1 (QL1) or lateral Quartus lumbumum block is used, which with the help of needle (22 G, 80 mm, stimuplex ultra 360 °) B Braun rupivacaine 0.5% at a rate of 0.3 ml / g and A maximum of 30 ml is performed at the lateral termination site of the abdominis transverse muscle with precise hyperdissection.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Shayegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen Street,  Velenjak, Chamran Highway,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839 69411</zip>
        <telephone>+98 21 2990 8040</telephone>
        <email>Shayegh@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara Shayegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yemen Street, Velenjak, Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19839 69411</zip>
        <telephone>+98 21 2990 8040</telephone>
        <email>Shayegh@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20 to 75 years
ASA Class I and II
Acetabular fractures
Elective surgery by Stoppa method
Lack of sensitivity to topical anesthetic drugs
No psychiatric diseases
No drug or psychedelic addiction
No fractures associated with trauma to other areas of the body
Patients weighing less than 85 kg</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of acetabular fracture surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S32.409</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified fracture of unspecified acetabulum</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>first Intervention group: Fascialiaka Block Group (FIB): In the supine position, after sterilizing the operation and performing cutaneous anesthesia, 2 cc of 1% lidocaine is injected at the site of the block. To perform nerve block, a high-frequency linear probe (10-25 MHz) of the ultrasound device (S-Nerre Sonosite) is used, which is placed horizontally in the inguinal region and in-plane with a needle (22 G, 80 mm). stimuplex ultra 360 °) B Braun is injected at a rate of 0.3 ml / kg and a maximum of 30 ml of 0.5% rupivacaine (manufactured by Molteni) with direct vision between the iliac fascia and the iliopsoas muscle.</i_keyword>
      <i_keyword>Second Intervention group: QL group: In the supine position, a cloth roll is placed in the lumbar spine to lift the hip into the block entry area. After sterilizing the solution and performing skin anesthesia with a 2 cc lidocaine syringe needle, a 1% high-frequency linear probe (10-25 MHz) is inserted between the Costa Margin iliac crest at the anterior axillary line. The goal is to find the three abdominal anterolateral muscles (external oblique, internal oblique, and abdominis transverse). By moving the probe towards the posterolateral and with the disappearance of the abdominis transversal muscle and its aponeurosis being identified in the axillary posterior line, the quadratus rubrum muscle can be found, which is characterized as a hypovaco area of ​​hypercoa aponeurosis. In this study, Curanasus lumburum 1 (QL1) or lateral Quartus lumbumum block is used, which with the help of needle (22 G, 80 mm, stimuplex ultra 360 °) B Braun rupivacaine 0.5% at a rate of 0.3 ml / g and A maximum of 30 ml is performed at the lateral termination site of the abdominis transverse muscle with precise hyperdissection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Morphine intake. Timepoint: 6, 12 and 24 hours after the operation. Method of measurement: Patient file information.</prim_outcome>
      <prim_outcome>Postoperative analgesia. Timepoint: 6, 12 and 24 hours after the operation. Method of measurement: Patient file information.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fentanyl used during surgery. Timepoint: During the surgery. Method of measurement: observation.</sec_outcome>
      <sec_outcome>The amount of morphine consumed. Timepoint: 24 hours after surgery. Method of measurement: observation.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: during surgery. Method of measurement: Blood pressure monitor.</sec_outcome>
      <sec_outcome>Heart beat. Timepoint: during surgery. Method of measurement: heart beat monitoring.</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>2020-09-01</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Yemen Street, Shahid Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
