<?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>IRCT20190417043295N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-03</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of dexmedetomidine and ketamine in serratus anterior plane block in pain control after thoracotomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of dexmedetomidine and ketamine in serratus anterior plate block in pain control of patients after thoracotomy surgery. A randomized clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66751</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Thoracotomy operations are usually performed within several months of sampling, and the required 74 patients will not undergo such an operation in the hospital at the same time. 74 sealed envelopes with cards inside that include 37 cards number 1 and 37 cards  number 2 are prepared and each patient is randomly selected for the group in which they will be studied.
 Description of groups:
1-Prescription of ropivacaine and dexmedetomidine
2- Prescription of ropivacaine and ketamine.</study_design>
      <phase>4</phase>
      <hc_freetext>Pain control of patients after thoracotomy surgery.</hc_freetext>
      <i_freetext>Intervention 1: First, the patient is placed in the supine or lateral decubitus position and a high-frequency linear transducer is used sagittally or transversely on the midaxillary line.  The transducer is slowly directed towards the back of the body to reveal the space between the latissimus dorsi and serratus anterior muscles, ribs and pleura.  After prep and drape, the needle (22 gauge model Dr. J-602 made by Dr. Japan) is used (in-plane or out of plane).  After aspiration, half of the surface solution is injected into the serratus anterior muscle in the depth of the latissimus dorsi muscle and the rest (the other half) in the depth of the serratus anterior muscle, and after the needle is removed, it is placed under pressure and an ice pack.  In the first group, ketamine 0.5 mg/kg and 0.4 cc/kg ropivacaine 0.25% and in the second  group, in addition to 0.4 cc/kg ropivacaine 0.25%, dexmedetomidine 0.5 macrogram/kilogram was added. Intervention 2: The second intervention group: the second group, dexmedtomidine 0.5 mcg/kg and 0.4 cc/kg rupivacaine 0.25%.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahbobeh Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>24 metery street, East sahely highway, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>0612222922</telephone>
        <email>rashidi-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahbobeh Rashidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>24 metery street, East sahely highway, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>0612222922</telephone>
        <email>rashidi-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Physical condition with ASA class 1 and 2
Age 18 to 60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dissatisfaction to attend the study
Injection site infection
Allergy to local anesthetic
BMI above 40
History of drug or alcohol abuse
Pregnancy or breastfeeding
History of coagulation problems or use of anticoagulants
History of HF and heart conduction disorders (except 1th degree block) and AF
Suffering from hepatorenal diseases
History of neuropsychological diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></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>First, the patient is placed in the supine or lateral decubitus position and a high-frequency linear transducer is used sagittally or transversely on the midaxillary line.  The transducer is slowly directed towards the back of the body to reveal the space between the latissimus dorsi and serratus anterior muscles, ribs and pleura.  After prep and drape, the needle (22 gauge model Dr. J-602 made by Dr. Japan) is used (in-plane or out of plane).  After aspiration, half of the surface solution is injected into the serratus anterior muscle in the depth of the latissimus dorsi muscle and the rest (the other half) in the depth of the serratus anterior muscle, and after the needle is removed, it is placed under pressure and an ice pack.  In the first group, ketamine 0.5 mg/kg and 0.4 cc/kg ropivacaine 0.25% and in the second  group, in addition to 0.4 cc/kg ropivacaine 0.25%, dexmedetomidine 0.5 macrogram/kilogram was added.</i_keyword>
      <i_keyword>The second intervention group: the second group, dexmedtomidine 0.5 mcg/kg and 0.4 cc/kg rupivacaine 0.25%</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Verbal Analog Scale (VAS). Timepoint: This criterion is rated as a continuous line, which is divided from 0-10 into equal intervals before inversion, one hour, six hours, twelve hours, twenty-four hours, and forty-eight hours later, and the patient uses it to reduce pain. He grades himself. Method of measurement: Based on the patient's self-rating of pain intensity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>O2 Saturation. Timepoint: Before intervention , one hour, six hours, twelve hours, twenty four hours and forty eight. Method of measurement: Based on measurement with pulse oximetry.</sec_outcome>
      <sec_outcome>Mean arterial pressure. Timepoint: Based on measurement. Method of measurement: mmHg.</sec_outcome>
      <sec_outcome>Heart beat. Timepoint: Based on measurement. Method of measurement: this The information includes body temperature, blood pressure, heart rate, breathing rate, as well as blood oxygen saturation and amount CO2 is the end of exhalation. Patient's pain using verbal pain index (Verbal Analog Scale);  that It is a subjective criterion for evaluating pain in patients and is widely used in medical studies.</sec_outcome>
      <sec_outcome>Duration of surgery. Timepoint: Based on measurement. Method of measurement: The duration of the surgery is recorded at the end of the surgery and transferred to the patient's checklist.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-01</approval_date>
        <contact_name>Ethics Committee in Golestan Hospital Research</contact_name>
        <contact_address>Iran,Golestan Ave, Golestan Hospital Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
