<?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>IRCT20121216011766N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-21</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of bupivacaine injection alone and in association with dexmedetomidine on pain and complications after inguinal hernia surgery</public_title>
      <acronym>TAP Block</acronym>
      <scientific_title>Comparing the effect of injecting Bupivacaine alone and in association with dexmedetomidine through transversus abdominis plane (TAP) block with ultrasound-guided on pain and complications after inguinal hernia surgery: A randomized controlled clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38034</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method. One of the nurses of the relevant ward, who is not aware of the implementation of the study will divide the patients into two groups of 33 marked as I and C as the intervention group and control group. Random sequences will be generated using the Random Generator program. Based on the random block method, 15 blocks of four-block and one six-block will be generated for 66 patients. After producing the list, each person will be assigned a dedicated code and will be recognized by this code during the study, Blinding description: Patients eligible for inclusion will be divided into 2 groups of 33 patients marked as I and C (intervention and control group) using the Blocked Randomization method, by One of the nurses of the relevant ward, who is not aware of the implementation of the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Transversus abdominis plane (TAP) block  with ultrasound guidance on pain and complications after inguinal hernia surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:20 milliliters of bupivacaine 0.5% with 1 milliliter (100 micrograms) of dexmedmotidine (Precedex brand containing 200 microgram / 2 milliliter of drug, HOSPIRA manufacturer reference of the United States of America). Intervention 2: Control group: 20 milliliter bupivacaine 0.5% plus 1 milliliter normal saline.</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:
The results of the research will be publicly available without mentioning the participants' names in the form of a research paper

When:
As soon as the article is published, the information will be publicly available in the general format

To whom:
researchers

Conditions:
To do research

Where to obtain:
Contact the relevant journal site or email and contact the responsible author

How to obtain:
Contact the relevant journal site or email and contact the responsible author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hoseein  Khoshrang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar jungel Avenue</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139638459</zip>
        <telephone>+98 132238306</telephone>
        <email>hkhoshrang@yahoo.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoseein khoshrang</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sardar jungel Ave</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4139638459</zip>
        <telephone>+98 132238306</telephone>
        <email>khoshrang@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 65 years old
Body mass index 35-18 kilogram / meter 2
Lack of drug sensitivity
No alcohol and drug addiction
Type of surgery including restoration without tension with mesh
ASA class I,II</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Surgery lasts more than 2 hours
Need for concurrent surgery during inguinal hernia surgery
Need to get opium in recovery room
excessive hemorrhage
Recurrence of hernia
Need for spinal anesthesia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pelvic and perineal pain</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:20 milliliters of bupivacaine 0.5% with 1 milliliter (100 micrograms) of dexmedmotidine (Precedex brand containing 200 microgram / 2 milliliter of drug, HOSPIRA manufacturer reference of the United States of America)</i_keyword>
      <i_keyword>Control group: 20 milliliter bupivacaine 0.5% plus 1 milliliter normal saline</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparing the effect of injecting Bupivacaine alone and in association with dexmedetomidine through Transversus Abdominis Plane(TAP) Block with ultrasound guidance in pain and complications after inguinal hernia surgery. Timepoint: In the recovery unit (at 0 o'clock) and at 2, 4, 6, 12, 24 hours after surgery, pain intensity will be measured in the two groups with visual analogue scale (VAS). Method of measurement: In this way, people are asked to show their pain intensity on a 10 cm ruler. no pain will be scored as zero and score 10 is for the highest pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>In 24 hours after surgery that patients are hospitalized in ward , they will be prescribed 0.5 milligram/kilogram of pethidine, if they need painkillers and they state VAS&gt; 3. Also, complications such as nausea, dizziness and vomiting, the first dose and the mean dose of pethidine consumed in the two groups will be investigated. Timepoint: In the recovery unit (at 0 o'clock) and at 2, 4, 6, 12, 24 hours after surgery. Method of measurement: Nausea, dizziness and vomiting.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-23</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences and Health Services</contact_name>
        <contact_address>Shahid Beheshti Highway Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
