<?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>IRCT201112318566N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-01-31</date_registration>
      <primary_sponsor>Hamedan Univercity of Medical Sciences- vice chancellor for research</primary_sponsor>
      <public_title>Epidural analgesia and PCA in pain relief after surgery</public_title>
      <acronym></acronym>
      <scientific_title>Analgesic effect and complications of thoracic  epidural  analgesia compared with IV- PCA(patient controlled analgesia ) in patients under thoracic and  upper  abdominal  surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>144</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9060</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Acute postoperative pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention in epidural group patients: after the replacement of the intravenous catheter and infusion of 500CC normal saline, 30 minutes before surgery, thoracic epidural catheter 20G through 18G needle in the intervertebral space T8-T9 or T7-T8 with Loss of resistance is placed in a sitting position. After fixing the catheter patients will undergo non-invasive monitors. A Test dose of bupivacaine% 0.25: 5ml with epinephrine 1 / 200000: 1ml is injected through the catheter. For surgical procedure all patients receive midazolam, fentanyl, thiopental and muscle relaxant for induction of anesthesia. In postoperative period a pharmaceutical composition containing 2mg of morphine and 6-8ml of 0.125% bupivacaine is injected through epidural catheter every 8 hours. Control of blood pressure and heart rate will be performed before induction of anesthesia and after transmit ion to the surgical ward, then will be recorded every 24 hours to 72 hours after the operation. Intervention 2: Intervention in PCA group: patients will be educated for proper use of PCA system in preoperative and postoperative periods. After surgery, morphine (1mg/ml) to the 2.5 ml (within 10-minute intervals by the patient) will be injected through a PCA pump.  After surgery, patients with certain commands for analgesia are transmitted to the ward. In all patients every 24 hours to 72 hours after surgery, amount of analgesia and the rate of complications, including complications due to surgery will be recorded. While patients are being discharged, they are questioned to determine the level of satisfaction.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Vahideh Shahnazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BESAT Hospital, General Operation Room, Motahhari Avenue, Resalat Square, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1264 0020</telephone>
        <email>Shahnazarivahideh@yahoo.com; v.shahnazari_22@yahoo.com</email>
        <affiliation>Hamedan Univercity of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Vahideh Shahnazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>BESAT Hospital, General Operation Room, Motahhari Avenue, Resalat Square, Hamedan</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 1264 0020</telephone>
        <email>shahnazarivahideh@yahoo.com</email>
        <affiliation>Hamedan Univeacity of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients who were candidate for thoracic or upper abdominal surgeries; between 18 to 70 years old and ASA class&lt;3.&#13;
Exclusion criteria: history of NSAIDs usage for long times; ASA class &gt;2; history of coagulation disorders; allergic reactions to local anesthetic drugs; patient inability for use of PCA pump; presence of significant neurologic disorders in lower limbs and addiction to opioid.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</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 in epidural group patients: after the replacement of the intravenous catheter and infusion of 500CC normal saline, 30 minutes before surgery, thoracic epidural catheter 20G through 18G needle in the intervertebral space T8-T9 or T7-T8 with Loss of resistance is placed in a sitting position. After fixing the catheter patients will undergo non-invasive monitors. A Test dose of bupivacaine% 0.25: 5ml with epinephrine 1 / 200000: 1ml is injected through the catheter. For surgical procedure all patients receive midazolam, fentanyl, thiopental and muscle relaxant for induction of anesthesia. In postoperative period a pharmaceutical composition containing 2mg of morphine and 6-8ml of 0.125% bupivacaine is injected through epidural catheter every 8 hours. Control of blood pressure and heart rate will be performed before induction of anesthesia and after transmit ion to the surgical ward, then will be recorded every 24 hours to 72 hours after the operation.</i_keyword>
      <i_keyword>Intervention in PCA group: patients will be educated for proper use of PCA system in preoperative and postoperative periods. After surgery, morphine (1mg/ml) to the 2.5 ml (within 10-minute intervals by the patient) will be injected through a PCA pump.  After surgery, patients with certain commands for analgesia are transmitted to the ward. In all patients every 24 hours to 72 hours after surgery, amount of analgesia and the rate of complications, including complications due to surgery will be recorded. While patients are being discharged, they are questioned to determine the level of satisfaction.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Acute postoperative pain. Timepoint: Every 24 hours to 72 hours. Method of measurement: Measurement of pain as Verbal, VAS.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complications of analgesic method that used for patient. Timepoint: Every 24 hours to  72 hours. Method of measurement: At the time of any symptoms such as itching, nausea and vomiting,  significant increase or decreas (over 20%) of blood presure ,respiratory depression and paresthesia or motor weakness of lower limbs.</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>Hamedan Univercity of Medical Sciences- vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-01-04</approval_date>
        <contact_name>Hamedan Univercity of Medical Siences Ethics Committee</contact_name>
        <contact_address>Mahdiye Street, Hamedan Univercity of Medical Siencies Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
