<?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>IRCT20221230056983N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effectiveness of intra-articular injection painkillers after cruciate ligament surgery</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison between intraarticular knee injection (Morphine, ketorolac) with and without Tranxamic acid  following arthroscopic ACL reconstruction surgery in reducing pain and assessing functional outcomes in patient with  isolated ACL injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-04-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67736</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Table of random numbers (four block) by site randomization.com, Blinding description: In our study, both the patients and the researchers are blinded to the prescription of the intervention drug, and the surgeon simply divides the patients into 2 groups, with and without the prescription of the drug, based on the argument of random numbers.</study_design>
      <phase>3</phase>
      <hc_freetext>isolated anterior cruciate ligament injury.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (5 cc), 33.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies. Intervention 2: Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc)100 mg of lidocaine (5 cc) 23.5 cc normal saline solution; All made by Iranian pharmaceutical companies.</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 ask for IPD through corresponding investigator</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behzad Nezhad Tabrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>009892166581653</telephone>
        <email>tabrizibehzad@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ayati Firozabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 6658 1653</telephone>
        <email>dr.mohammad.ayati@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>an isolated, unilateral, chronic ACL tear
Ability to read and write to give informed written consent and cooperate in the study
Use of hamstring autograft
American Society of Anesthesiologists (ASA) physical status of I</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug sensitivity
multi-ligament injuries
bilateral ACL tears
acute ACL tears
bony deformities
a history of hematologic conditions or ischemic attacks
patients receiving anticoagulant therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sprain and strain involving (anterior)(posterior) cruciate ligament of knee</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>Control group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc),100 mg of lidocaine (5 cc), 33.5 cc of normal solution Saline; All made by Iranian pharmaceutical companies</i_keyword>
      <i_keyword>Intervention group: Intra-articular injection of 40 cc of analgesic cocktail after surgery including: 30 mg Ketorolac ampoule (1 cc), 5 mg of morphine sulfate (0.5 cc), 1 gram of tranexamic acid (TXA) (10 cc)100 mg of lidocaine (5 cc) 23.5 cc normal saline solution; All made by Iranian pharmaceutical companies</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain variables including the amount of pain based on Visual Analogue Scale (VAS). Timepoint: The pain level of the patients is based on the Visual Analoque Scale or VAS with a score from 1 to 10, which is measured in the intervals of one hour, two hours, 3 hours, 6 hours, 12 hours, one week, one month and three months after the operation. Method of measurement: The level of patient satisfaction are measured based on the Visual Analogue Scale index.</prim_outcome>
      <prim_outcome>Functional variables in patients including Knee Injury and Osteoarthritis Outcome Score (KOOS). Timepoint: It is measured before surgery, one month and three months after surgery. Method of measurement: The score of the KOOS or Knee injury and Osteoarthritis Outcome Score questionnaire examines the patient in 5 areas and its score is 0 to 100%.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Functional variables in patients including Lysholm. Timepoint: Lysholm questionnaire score from 0 to 100, before surgery, one hour, one month and three months after surgery. Method of measurement: The performance of all patients is completed and evaluated based on the Lysholm questionnaire.</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>2022-08-30</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Joint Reconstruction Research Center, Orthopedic Department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
