<?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>IRCT20190314043050N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-27</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Serratus anterior plane block technique in multiple traumatic rib fractures</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Serratus anterior plain block technique with intercostal nerve block technique in reducing pain following multiple rib fractures in emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38347</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Patients are randomly divided into control and test groups by the complete randomization method, Blinding description: after completing interventions, patients' evaluation checklist will be decoded. Assessment and registration is carried out by a specific person for each patient. These evaluators are blind to the type of the procedure performed in the recovery room. In fact, Patient information is recorded before and after the process by the assistant who is unaware of the him/her study grouping.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple traumatic rib fractures.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  serratus anterior plane block technique under ultrasound guidance. This method is similar to the pectoralis nerve and trans-abdominal plate blocks and, due to the special anatomy of the Sarratus muscle, it traverses a wide area of ​​the chest wall. Patients in the intervention group will be in a supine position with the hands placed above the head. After providing sterile conditions, local anesthetic technique begins. An ultrasound linear probe of 3 to 16 MHz is placed in the middle axillary line at the fifth rib. A Touhy's 18G needle is placed between the anterior serratus and the external intercostal muscles. After negative aspiration and confirmation of needle location by initial hydro-dissection with 2 to 3 ml of solution, 20 ml of  Ropivacaine hydrochloride will be injected 5 mg / ml in the cephalad_caudal direction on the plate. Intervention 2: Control group: intercostal nerve block. This procedure is done between the posterior and middle axillary lines. A 10-ml syringe with a needle of 3.375 and 25 guage is used. The skin of the affected area will be prepared by the usual aseptic method. To perform this technique, the  second finger of the non-dominant hand  draws the lower edge of the rib upwards. The needle at an angle of 80 degrees to the chest wall, enters the skin to slowly hit the lower edge of the rib. At this time, the finger is removed and the needle is pulled in the intercostal space. We dip the needle 3 millimeter and aspirate. Then, 2 to 4 ml of ropivacaine hydrochloride will be given at a dose of 5 mg / ml to a maximum dose of 2.5 mg per kg body weight. The procedure is repeated in two gears up and down the premises.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The whole potential data can be shared after identifying individuals and their information

When:
Since 1399

To whom:
Researchers working in academic institutions

Conditions:
-

Where to obtain:
Ah_meysami@kums.ac.ir

How to obtain:
After contacting the designer email
Ah_meysami@kums.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amirhossein Meysami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Blvd, Imam Reza hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3427 6301</telephone>
        <email>ah_meysami@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amirhossein Meysami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Blvd, Imam Reza hospital</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715847141</zip>
        <telephone>+98 83 3427 6301</telephone>
        <email>ah_meysami@kums.ac.ir</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients referred to Imam Reza and Ayatollah Taleghani hospital in Kermanshah, with a complaint of blunt thoracic trauma during 2019
Visual analogue scale of four and more
Initial systolic blood pressure of 90 mmHg and more
Three-rib fractures and more
The patient should be monitored at least twelve hours after interventions</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Opium addicted patients
Pathologic and/or Nontraumatic rib fractures
Bilateral rib fractures
history of allergy to local anesthetics
Pregnancy and/or breastfeeding
People with mental and psychological problems who are not able to answer questions
Tension pneumothorax occurs
Need to intubation and mechanical ventilation
Patient dissatisfaction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fracture of rib(s), sternum and thoracic spine</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>Intervention group:  serratus anterior plane block technique under ultrasound guidance. This method is similar to the pectoralis nerve and trans-abdominal plate blocks and, due to the special anatomy of the Sarratus muscle, it traverses a wide area of ​​the chest wall. Patients in the intervention group will be in a supine position with the hands placed above the head. After providing sterile conditions, local anesthetic technique begins. An ultrasound linear probe of 3 to 16 MHz is placed in the middle axillary line at the fifth rib. A Touhy's 18G needle is placed between the anterior serratus and the external intercostal muscles. After negative aspiration and confirmation of needle location by initial hydro-dissection with 2 to 3 ml of solution, 20 ml of  Ropivacaine hydrochloride will be injected 5 mg / ml in the cephalad_caudal direction on the plate.</i_keyword>
      <i_keyword>Control group: intercostal nerve block. This procedure is done between the posterior and middle axillary lines. A 10-ml syringe with a needle of 3.375 and 25 guage is used. The skin of the affected area will be prepared by the usual aseptic method. To perform this technique, the  second finger of the non-dominant hand  draws the lower edge of the rib upwards. The needle at an angle of 80 degrees to the chest wall, enters the skin to slowly hit the lower edge of the rib. At this time, the finger is removed and the needle is pulled in the intercostal space. We dip the needle 3 millimeter and aspirate. Then, 2 to 4 ml of ropivacaine hydrochloride will be given at a dose of 5 mg / ml to a maximum dose of 2.5 mg per kg body weight. The procedure is repeated in two gears up and down the premises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score changes in visual analogue scale system. Timepoint: Immediately after the intervention, the first 30 minutes, one, six, and 12 hours after. Method of measurement: Visual analogue scale and modified Qor-40 score checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dosage of Fentanyl used. Timepoint: thirty minutes to twelve hours after intervention. Method of measurement: Microgram per Kg.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-24</approval_date>
        <contact_name>Ethics committee of Kermanshah university of medical sciences</contact_name>
        <contact_address>Parastar blvd, Imam Reza hospital Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
