<?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>IRCT20100127003213N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intraincisional bupivacaine infusion in intertrochanteric fracture</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of continuous infusion of bupivacaine through intra-incisional catheter with control group for postoperative pain relieve in patients with intertrochanteric fracture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44951</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be allocated into intervention and control groups by block randomization using randomization.com website. This will randomly generate a sequence of 12 blocks, 4 patients in each. The name of the patients'  group will be concealed in separate envelops which are identified by consecutive numbers related to the patient's entrance to the study.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Femur fracture.</hc_freetext>
      <i_freetext>Intervention 1: Interventions group 1:At the end of the surgery an intra-incisional catheter (Infiltralong 600, PAJUNK, Geisingen, Germany) will be placed subfascially which will be connected to a 100 mL elastomeric pump, contained 0.25% bupivacaine by the rate of 6 ml per hour, after a 30 mL bolus dose of 0.25% bupivacaine (Bupivacaїne® Mylan, 100 mg/20 ml vial, Delpharm, France). The intra-incisional catheter will be disconnected after 36 hours. Intervention 2: Control group:The surgeon does not insert a Intra incisional catheter(Infiltralong manufacturing company. Pajunk of Germany)before the surgical wound is placed under the fascia layer.After the bolus injection of 2 ml of morphine sulfate( Aburaihan Pharmaceutical Co. Iran,) the pump settings are as follows:20 ml of morphine sulfate at a concentration of 0.5 mg / ml in normal saline solution infused with infusion pump .Minimum injection interval: 7 minutes, maximal injection every 4 hours: 40 ml, and continued for 24 hours. infusing morphine, intravenously.</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 It is against our policies.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sanaz Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134844119</zip>
        <telephone>+98 71 3647 4270</telephone>
        <email>sanaz_med65@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Farbood</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Faghihi Hospital, Zand Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1564471948</zip>
        <telephone>+98 36474270</telephone>
        <email>arashfarbood@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who scheduled to undergo hip nailing surgery and can tolerate surgery under spinal anesthesia
American Society of Anesthesiologists (ASA) I-II
50-85 years of age</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncontrolled seizure
Local infection
Coagulopathy
Thrombocytopenia
History of hepatic and renal function impairment
narcotic addiction
Allergy to drugs which are going to be used in this study
History of Psychosomatic pain
Psychiatric diseases
Diabetic neuropathy
2nd and 3rd degree A-V block</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S72.14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intertrochanteric fracture of femur</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions group 1:At the end of the surgery an intra-incisional catheter (Infiltralong 600, PAJUNK, Geisingen, Germany) will be placed subfascially which will be connected to a 100 mL elastomeric pump, contained 0.25% bupivacaine by the rate of 6 ml per hour, after a 30 mL bolus dose of 0.25% bupivacaine (Bupivacaїne® Mylan, 100 mg/20 ml vial, Delpharm, France). The intra-incisional catheter will be disconnected after 36 hours.</i_keyword>
      <i_keyword>Control group:The surgeon does not insert a Intra incisional catheter(Infiltralong manufacturing company. Pajunk of Germany)before the surgical wound is placed under the fascia layer.After the bolus injection of 2 ml of morphine sulfate( Aburaihan Pharmaceutical Co. Iran,) the pump settings are as follows:20 ml of morphine sulfate at a concentration of 0.5 mg / ml in normal saline solution infused with infusion pump .Minimum injection interval: 7 minutes, maximal injection every 4 hours: 40 ml, and continued for 24 hours. infusing morphine, intravenously.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: Every 15 minutes after surgery (15, 30, 45, 60 minutes) in  recovery room, and every 2 hours after transfer to ward . Method of measurement: Numerical Rating Scale of pain.</prim_outcome>
      <prim_outcome>Total morphine administration. Timepoint: total dose during the first postoperative 24 hours. Method of measurement: dose summation reported in milligrams.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient’s global satisfaction. Timepoint: Discharge from the ward. Method of measurement: َA 5-point Likert scale: completely satisfied (= 5), partially satisfied (= 4), neutral (= 3), partially dissatisfied (= 2) and completely dissatisfied (= 1).</sec_outcome>
      <sec_outcome>Ease of ambulation. Timepoint: During admission. Method of measurement: Cumulated Ambulation Score.</sec_outcome>
      <sec_outcome>Time to first request for analgesia. Timepoint: Time to first request, measured from termination of the procedure and recovery room entry. Method of measurement: minute.</sec_outcome>
      <sec_outcome>Drug side effects (nausea &amp; vomiting, respiratory depression, urinary retention, drowsiness, pruritus, hypotension, tinnitus). Timepoint: Every four hours for 24 hours. Method of measurement: Occurrence frequency.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-04-27</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
