<?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>IRCT2013071411700N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-29</date_registration>
      <primary_sponsor>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Patient-Controlled Epidural Analgesia with Intravenous Patient-Controlled Analgesia on Postoperative Pain Control after Major Gynecologic Oncologic Surgery-A Randomized controlled clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Postoperative Pain after Gynecologic Oncologic Surgery Epidural and Intravenous</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11877</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Postoperative Pain Control after  Gynecologic Oncologic Surgery.</hc_freetext>
      <i_freetext>Intervention 1: After surgery, In recovery room for group one (IPCA) or which group that will receive  intra venous PCA, analgesic will be infused, which contain 300 µg (6ml) fentanyl, 200mg (4ml) petidine and 8mg(2ml) ondansetron in Normal saline 0.9% with the total volume of 100 ml. First the speed of infusion will be ml/h 8-6, blouse administration of 2 ml every 15 minute  are given by patient  as needed. Intervention 2: Group 2 PCEA will receive epidural catheter from L3-L4 interspaces and only test dose(lidocaine 1.5% 3-4 ml  and Epinephrine 1/200000) will be administrated. Group 2 will receive Bupivacaine 0.5%  100 mg  fentanyl  150 µg (3ml)in Normal saline with total volume of 100 ml. Rate of infusion will be 6-8 ml/h and blouse administration of 2 ml every 15 minute as needed.</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. Farnaz Moslemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Hospital, south artesh Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>moslemi_fa@yahoo.com</email>
        <affiliation>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farnaz Moslemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Hospital, South Artesh Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1553 9161</telephone>
        <email>moslemi_fa@yahoo.com</email>
        <affiliation>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Women’s with  gynecologic Oncologic Surgery in the operation list of Alzahra Hospital; Women’s with ASA class I and II; patients who wannt to contribute in the study&#13;
  &#13;
Exclusion criteria:&#13;
Women’s with ASA class III or higher; Severe cardiovascular diseases; Epidural anesthesia contraindications;Coagulation disorders or antiquagulant drugs using with therapeutic dose; Spin anomalies; Sepsis; Hypovolemic shock</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C51-58</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms of female genital organs</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>After surgery, In recovery room for group one (IPCA) or which group that will receive  intra venous PCA, analgesic will be infused, which contain 300 µg (6ml) fentanyl, 200mg (4ml) petidine and 8mg(2ml) ondansetron in Normal saline 0.9% with the total volume of 100 ml. First the speed of infusion will be ml/h 8-6, blouse administration of 2 ml every 15 minute  are given by patient  as needed.</i_keyword>
      <i_keyword>Group 2 PCEA will receive epidural catheter from L3-L4 interspaces and only test dose(lidocaine 1.5% 3-4 ml  and Epinephrine 1/200000) will be administrated. Group 2 will receive Bupivacaine 0.5%  100 mg  fentanyl  150 µg (3ml)in Normal saline with total volume of 100 ml. Rate of infusion will be 6-8 ml/h and blouse administration of 2 ml every 15 minute as needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative analgesia. Timepoint: Postoperative 2, 4, 6, 8, 12, 24 and 36 hours. Method of measurement: Severity os pain with Visual Analoge Scale(VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sedation. Timepoint: Posoperative 4, 6, 8, 12, 24, 36 hours. Method of measurement: Modified Ramsy sedation scale.</sec_outcome>
      <sec_outcome>Patient's satisfaction. Timepoint: On the fifth day postoperative. Method of measurement: Score according to postoperative analgesia (nil = 0;.</sec_outcome>
      <sec_outcome>Nausea and vomiting. Timepoint: Postoperative 2, 4, 6, 8, 12, 24, 36 hours. Method of measurement: Severity of Nausea and vomiting with Belville scorhng.</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>Women's Reproductive Health Research Center, Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-11</approval_date>
        <contact_name>Tabriz University of medical Sciences</contact_name>
        <contact_address>Daneshgah Ave, Tabriz University of medical Sciences Tabriz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
