<?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>IRCT2015092924268N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-12-07</date_registration>
      <primary_sponsor>Vice Chancellor For Research of Tehran Medical School, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of nerve blocks and epidural anesthesia on stress response in patients undergoing general anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of TAP Block and Epidural A. on post operative stress response of elective laparoscopic cholecystectomy surgery in shariati hospital -1393</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20528</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>General Anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: At the beginning of surgery before anesthesia induction, TAP BLOCK performed by the Professor of Anesthesiology and with the method of Ultrasound guided Transversus Abdominus plane block with 20 cc Bupivacaine 0.5%. Intervention 2: Initially with 2cc lidocaine 2%, local anesthesia were created then through the number 18 epidural needle inserted into the epidural space then made sure of the correct position of epidural space, 25 cc Bupivacaine 0.25% will be injected.</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>Piroozeh Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr shariati Hospital, Jalal Al Ahmad Street, Northen Kargar Street, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8822 0032</telephone>
        <email>ven_17@yahoo.com</email>
        <affiliation>Anesthesiology Department, Dr Shariati Hospital, Tehran University of Medical Sciences, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Movafegh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Dr Shariati Hospital, Tehran University of Medical Sciences, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8822 0032</telephone>
        <email>movafegh@sina.tums.ac.ir</email>
        <affiliation>Department of Anesthesiology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 18-50 years; BMI&lt;30; Stage 1 and 2 ASA; Surgery time less than 2 hours; Absence of systemic disease such as (heart or lung disease and serious liver-Kidney disease); Absence of contraindications to epidural anesthesia (coagulopathies, infection at needle insertion site, The patient's lack of cooperation, Absence of consent); Absence of any contraindications to perform Block; Absence of a history of immunosuppressive and corticosteroid drugs; Absence of a history of drug addiction and smoking. Exclusion criteria: Failing to block; Incidence of complications during surgery and laparotomy for any reason; Prolongation of operation (more than 2 hours)</inclusion_criteria>
      <agemin>17 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T41.1, T41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Intravenous Anesthetics, Other and Unspecified General Anesthetic, Local Anesthetics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>At the beginning of surgery before anesthesia induction, TAP BLOCK performed by the Professor of Anesthesiology and with the method of Ultrasound guided Transversus Abdominus plane block with 20 cc Bupivacaine 0.5%</i_keyword>
      <i_keyword>Initially with 2cc lidocaine 2%, local anesthesia were created then through the number 18 epidural needle inserted into the epidural space then made sure of the correct position of epidural space, 25 cc Bupivacaine 0.25% will be injected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Objective success rate of blockage for anesthesia by injection and deposition of sediment material (Marcaine) between the layers of muscle (IOM and TAM). Timepoint: During of surgery. Method of measurement: Ultrasound sonography.</prim_outcome>
      <prim_outcome>The Subjective Success Rate of Block. Timepoint: 30 minute. Method of measurement: Check the skin sensation of the same area of block in the epigastric and umbilical and groin.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Immediately, 6, 12, 24 hours after discharge from recovery. Method of measurement: Visualized Analogue Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Sugar ,WBC , CRP , Cortisol, TNF-α and IL-1 level of serum. Timepoint: Before induction of anesthesia and 6 and 24 hours after extubation of patient. Method of measurement: Blood Exam.</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 of Tehran Medical School, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-11</approval_date>
        <contact_name>Vice Chancellor For Research of Tehran Medical School, Tehran University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor For Research of Tehran Medical School, Tehran University of Medical Sciences, Poursina Street, Keshavarz Blvd, Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
