<?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>IRCT20260708070098N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-20</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Post thoracotomy pain management</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of epidural catheter with ketamine drip in analgesia after elective thoracotomies</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/91534</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using the random permutation block method. In this method, the block sizes are 4 and 2 (in random order) and the allocation ratio is 1:1. In this way, an equal number of each treatment will be provided in each block. The random sequence will be generated by the methodologist using the sealedenvelope.com software. The random allocation list of the clusters will be available only to the design methodologist. In order to conceal the randomization process, 72 paper labels will be written with random 10-digit codes without a specific order and frame, which will be the identification number of the relevant treatment, and only the design methodologist will be aware of the relevant code. The labels will be attached to the drug packages in the order of the randomization list. The drug packages will be arranged in a box in the order of the randomization list. When the physician declares a patient eligible, the design methodologist will provide the patient with the treatment package. The design methodologist will be excluded from the rest of the study processes, Blinding description: The study is single-blind. The drugs used in the two groups are prepared in identical containers without name labels, in the same color and smell, and are coded. They are provided to both groups based on random allocation by the project partner, so none of the patients are aware of the treatment assigned and will not be informed until the end of the study.</study_design>
      <phase>2</phase>
      <hc_freetext>Thoracotomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, after induction of anesthesia before the first incision, 0.3 mg/kg intravenous ketamine is administered as a bolus, followed by intravenous infusion at a rate of 0.3 mg/kg/hour for patients. In case of postoperative pain (VAS score &gt; 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded. Intervention 2: Control group: In this group, at the end of the operation, epidural infusion of 0.2% ropivacaine is started in all patients at an infusion rate of 10 cc/hour. In case of postoperative pain (VAS score &gt; 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Matin Vahedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, before reaching Hassan Abad Square, Imam Khomeini Street (RA)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8500</telephone>
        <email>hosp_sina@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Fatemeh Tabesh Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, before reaching Hassan Abad Square, Imam Khomeini Street (RA)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8500</telephone>
        <email>fatemehtabesh64@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Indications for Thoracotomy
Age between 18 and 70 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death before thoracotomy
Patients with known coagulation disorders
Uncontrolled diabetes
History of addiction
Allergy to ketamine
History of psychiatry diseases
History of seizures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S21.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Open wound of front wall of thorax</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 this group, after induction of anesthesia before the first incision, 0.3 mg/kg intravenous ketamine is administered as a bolus, followed by intravenous infusion at a rate of 0.3 mg/kg/hour for patients. In case of postoperative pain (VAS score &gt; 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded.</i_keyword>
      <i_keyword>Control group: In this group, at the end of the operation, epidural infusion of 0.2% ropivacaine is started in all patients at an infusion rate of 10 cc/hour. In case of postoperative pain (VAS score &gt; 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain. Timepoint: 2,4,8,12,24,48 hours postoperative. Method of measurement: Visual Analog Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic Blood Pressure. Timepoint: 2,4,8,12,24,48 h postoperative. Method of measurement: mm/Hg.</sec_outcome>
      <sec_outcome>Diaystolic Blood Pressure. Timepoint: 2,4,8,12,24,48 h postoperative. Method of measurement: mm/Hg.</sec_outcome>
      <sec_outcome>Diaystolic Blood Pressure. Timepoint: 2,4,8,12,24,48 h postoperative. Method of measurement: Respiratory rate for min.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: 2,4,8,12,24,48 h postoperative. Method of measurement: Heart Rate for 1 min.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-19</approval_date>
        <contact_name>Research Ethics Committees of Sina Hospital - Tehran University of Medical Sciences</contact_name>
        <contact_address>Sina Hospital, before reaching Hassan Abad Square, Imam Khomeini Street (RA) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
