<?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>IRCT20141209020258N135</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-06</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Transversus Abdominis Plane(TAP)  Block on pain control after open Appendectomy  in uncomplicated acute appendicitis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Transversus Abdominis Plane(TAP)  Block on pain control after open Appendectomy  in uncomplicated acute appendicitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46340</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in two groups A and B .
In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind). Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups  A and B are available to analyzer and outcome assessor.</study_design>
      <phase>3</phase>
      <hc_freetext>Appendicitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In intervention group, we place the probe in the abdominal wall on the mid-axillary line between the lower ribs and Crest Iliac before general anesthesia and under ultrasound after finding the extrinsic and intrinsic ablative muscles and the abdominal transducer nidel muscle entered the skin along the probe and 20 cc bupivacaine 0.25% injection this site. Intervention 2: Control group: In the control group, we injected 20 cc normal saline into the petit triangle between the abdominal intrinsic muscle and the transducer abdominis muscle.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
When we publish article in journal

When:
After the article is published

To whom:
Researcher in university

Conditions:
If there are additional questions

Where to obtain:
Dr Amirreza Naeemi

How to obtain:
They have to write letters to the professors and the university

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Siamak Rakei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Valiasr squre, Shahid Shirodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 68 3222 2003</telephone>
        <email>s.rakei@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Amirreza Naeemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr Hospital, Valiasr squre, Shahid Shirodi street</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3814957558</zip>
        <telephone>+98 68 3222 2003</telephone>
        <email>naeemi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ages 18  to 65 years
No underlying disease
Surgery less than one hour
No addiction
Absence of connective tissue disease
Absence of rheumatic disease
Diagnosis of uncomplicated acute appendicitis</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with perforated appendicitis
Ovarian cyst rupture
Tubo ovarian abscess</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute appendicitis</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 group: In intervention group, we place the probe in the abdominal wall on the mid-axillary line between the lower ribs and Crest Iliac before general anesthesia and under ultrasound after finding the extrinsic and intrinsic ablative muscles and the abdominal transducer nidel muscle entered the skin along the probe and 20 cc bupivacaine 0.25% injection this site</i_keyword>
      <i_keyword>Control group: In the control group, we injected 20 cc normal saline into the petit triangle between the abdominal intrinsic muscle and the transducer abdominis muscle</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: In recovery and 2, 4, 6, 12, 24 and 48 hours after open appendectomy. Method of measurement: Visual analogue pain questionnaire.</prim_outcome>
      <prim_outcome>Mean of narcotic drug. Timepoint: 24 hours after surgery. Method of measurement: Milligram.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-29</approval_date>
        <contact_name>Ethics comittee of Arak University of Medical Sciences</contact_name>
        <contact_address>Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
