<?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>IRCT2015090919373N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-24</date_registration>
      <primary_sponsor>Avicenna Research Institute</primary_sponsor>
      <public_title>The effect of Transverse abdominal plane block and local infiltration of anesthesia in post operative laparoscopic pain</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of comparison between transverse abdominal plane block versus local infiltration of anesthesia in post operative laparoscopic pain among Endometriosis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-01-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Other</recruitment_status>
      <url>https://irct.ir/trial/17338</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>Condition 1: Endometriosis of uterus. Condition 2: Endometriosis of ovary. Condition 3: Endometriosis of fallopian tube. Condition 4: Endometriosis of pritoneum. Condition 5: Endometriosis of recovagina. Condition 6: Endometriosis of intestine.</hc_freetext>
      <i_freetext>Intervention 1: Transverse abdominal plane block group receive 0.6 milliliter per kilogram normal saline subcutaneously before incision for Trocar as placebo and at the beginning inject 0.6 milliliter per kilogram Bupivacaine 0.25% by using needle number 22G  between internal oblique and transverse abdominal muscle after negative aspiration and two POP sensation under laparoscopic guide which divided equally in 4 places at right and left side. Intervention 2: Local infiltration group receive 0.6 milliliter per kilogram Bupivacaine 0.25% subcutaneously at the beginning before skin incision for trocar in four places in equal volume and 0.6 milliliter per kilogram normal saline as placebo under laparosopic guide between internal oblique and transverse abdominal muscle in four places with equal volume in right and left side. Intervention 3: Placebo group receive 0.6 milliliter per kilogram normal saline subcutaneously as placebo in four places in equal volume before skin incision for trocar and then 0.6 milliliter per kilogram normal saline as placebo under laparoscopic guide in four places in equal volume between internal oblique and transverse abdominal plane in right and left side.</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>Roxana Kargar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 5, 3rd Felestin, Felestin, Estanboul, Hasan Akbari, Pole Roumi, Shariati</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2221 7065</telephone>
        <email>roxanakargar@yahoo.com</email>
        <affiliation>Avicenna Research Institute</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shaheen Khazali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.97, Shariati street, first of Yakhchal Avenue</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1964844685</zip>
        <telephone>+44 7952 040416</telephone>
        <email>s.khazali@me.com</email>
        <affiliation>Avicenna Research Institute</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Women between 18 to 50 years old; ASA classification less than 3 ; candidate for elective laparoscopic surgery for endometriosis; take consent for entrance; no addiction to opiate; no companion with other illnesses such as liver, kidney, or psychotic diseases. Exclusion criteria: Tendency of patient for exclusion; allergy to  drugs; laparoscopic surgery converted to  laparotomy; coagulopathy disease; patients without cooperation; hospitalize less than 24 hours; bowel anastomosis</inclusion_criteria>
      <agemin>76 years</agemin>
      <agemax>44 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N80.0</hc_code>
      <hc_code>N80.1</hc_code>
      <hc_code>N80.2</hc_code>
      <hc_code>N80.3</hc_code>
      <hc_code>N80.4</hc_code>
      <hc_code>N80.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endometriosis of uterus Adenomyosis</hc_keyword>
      <hc_keyword>Endometriosis of ovary</hc_keyword>
      <hc_keyword>Endometriosis of fallopian tube</hc_keyword>
      <hc_keyword>Endometriosis of pelvic peritoneum</hc_keyword>
      <hc_keyword>Endometriosis of rectovaginal septum and vagina</hc_keyword>
      <hc_keyword>Endometriosis of intestine</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Transverse abdominal plane block group receive 0.6 milliliter per kilogram normal saline subcutaneously before incision for Trocar as placebo and at the beginning inject 0.6 milliliter per kilogram Bupivacaine 0.25% by using needle number 22G  between internal oblique and transverse abdominal muscle after negative aspiration and two POP sensation under laparoscopic guide which divided equally in 4 places at right and left side.</i_keyword>
      <i_keyword>Local infiltration group receive 0.6 milliliter per kilogram Bupivacaine 0.25% subcutaneously at the beginning before skin incision for trocar in four places in equal volume and 0.6 milliliter per kilogram normal saline as placebo under laparosopic guide between internal oblique and transverse abdominal muscle in four places with equal volume in right and left side.</i_keyword>
      <i_keyword>Placebo group receive 0.6 milliliter per kilogram normal saline subcutaneously as placebo in four places in equal volume before skin incision for trocar and then 0.6 milliliter per kilogram normal saline as placebo under laparoscopic guide in four places in equal volume between internal oblique and transverse abdominal plane in right and left side.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Severity of post operative pain in 2 to 4 , 6 to 8 , 10 to 12 and 24 hours after surgery. Method of measurement: Ask patients by VNRS scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea. Timepoint: 2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery. Method of measurement: Patient expression.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: 2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery. Method of measurement: Number of vomiting.</sec_outcome>
      <sec_outcome>Morphine consumption. Timepoint: 2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery. Method of measurement: miligramme.</sec_outcome>
      <sec_outcome>Time of first injection of morphine. Timepoint: 2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery. Method of measurement: Hour.</sec_outcome>
      <sec_outcome>Complication of injection. Timepoint: 2 to 4, 6 to 8, 10 to 12, and 24 hours after surgery. Method of measurement: Yes, No.</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>Avicenna Research Institute</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-17</approval_date>
        <contact_name>Avicenna</contact_name>
        <contact_address>No 97, Yakhchal avenue, Shariati  street Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
