<?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>IRCT201010194938N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-30</date_registration>
      <primary_sponsor>Vice chancellor for research Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Effect of adding tramadol to Bupivacaine on postoperative pain.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of  the effects of adding tramadol to Bupivacaine on postoperative pain in inguinal hernia surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5282</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ingunal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Group 1 ; After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal salin is injected subfacial in external oblique muscle at the end of surgery by surgeon. Intervention 2: After general anesthesia (sufentanil 10 mcg ,midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml =100mg tramadol is injected subfacial in external oblique muscle at the end of surgery by surgeon. Intervention 3: After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal saline is injected subfacial in external oblique muscle at the end of surgery by surgeon. Tramadol 100mg is injected also intramuscularly , 15 minutes after surgery.</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>Hossein Farzam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 floor-number, 18-116 alley-nobahar ave</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1837 6906</telephone>
        <email>hfarzam@kums.ac.ir</email>
        <affiliation>Kermanshah university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Farzam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>4 floor-number, 18-116 alley-NOBAHAR ave</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 1837 6906</telephone>
        <email>اhfarzam@kums.ac.ir</email>
        <affiliation>kermanshah university of medicine student</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>In this study, the candidates for open-elective unilateral inguinal herniorrhaphy with age between 12 &amp; 75 are enrolled if been satisfied. &#13;
Patients with  ASA class more than II, have hernia recurrence, drug addiction, patients with DM (diabetes mellitus),  patients who have hypersensitivity to anesthetic drugs and who develope postoperative inflammation or hematoma of surgical site are excluded.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k40-9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral or unspecified inguinal hernia, without obstruction or gangrene</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1 ; After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal salin is injected subfacial in external oblique muscle at the end of surgery by surgeon.</i_keyword>
      <i_keyword>After general anesthesia (sufentanil 10 mcg ,midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml =100mg tramadol is injected subfacial in external oblique muscle at the end of surgery by surgeon.</i_keyword>
      <i_keyword>After general anesthesia (sufentanil 10 mcg, midazolam 1 mg , isoflurane o.6% , atracurium) 8 ml bupivacaine 0.25% + 2ml normal saline is injected subfacial in external oblique muscle at the end of surgery by surgeon. Tramadol 100mg is injected also intramuscularly , 15 minutes after surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity. Timepoint: 2, 4, 8, 12 hourse after suegery. Method of measurement: Visual Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Level of conscious. Timepoint: 2,4,8,12. Method of measurement: 3 point scale.</sec_outcome>
      <sec_outcome>The 1th analgesic request. Timepoint: 2,4,8,12. Method of measurement: time report.</sec_outcome>
      <sec_outcome>Total analgesic intake. Timepoint: 2,4,8,12. Method of measurement: mg.</sec_outcome>
      <sec_outcome>Nausea &amp; Vomiting. Timepoint: 2,4,8,12. Method of measurement: Observation &amp;Question.</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>Vice chancellor for research Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-06-15</approval_date>
        <contact_name>Medical ethics committee of Kemrmanshah university of Medical Sciences</contact_name>
        <contact_address>Shahid beheshti ave Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
