<?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>IRCT20210613051559N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of intraarticular and periarticular injection of cocktail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in patients with knee degenerative joint disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56857</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: simple randomization
triple blind (the patient the analyser and the researcher gathering datea are not informed of the type of allocation)
the allocation of each patient is determined according to the numbers generated by randomization software and is documented in sealed envelope. during the operation, the envelope is opened and  the surgeon is informed of the type of allocation at the time of prosthesis insertion by his operative staff, Blinding description: the allocation of each patient is determined according to the numbers generated by randomization software and is documented in sealed envelope. during the operation, the envelope is opened and  the surgeon is informed of the type of allocation at the time of prosthesis insertion by his operative staff.</study_design>
      <phase>3</phase>
      <hc_freetext>knee degenerative joint disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intrarticular analgesic cocktail (MS, ropivacain, ketorolac, epinephrin) injection 100 cc. Intervention 2: Intervention group: periarticular injection of analgesic cocktail 100 cc. Intervention 3: Intervention group: intra (50cc) and peri articular (50 cc) injection of analgesic cocktail.</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:
Comparision of the effect of intraarticular and periarticular injection of coctail of morphin epinephrin ropivacain ketorolac on eliminating the postoperative pain after total knee arthroplasty in knee arthrotic patients referred to the joint reconstruction research center of imamkhomeini hospital

When:
at the end of the study

To whom:
academic institution

Conditions:
scientific journal

Where to obtain:
for comparing the clinical outcom the data is aimed to be shared online

How to obtain:
email request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyed mohammad javad mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 8827 0873</telephone>
        <email>smjmort@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>farzad vosoughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Joint Reconstruction Research Center, Orthopedicsurgery department, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran.</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>009888270873</telephone>
        <email>farzadvosooghi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>those aged 18-80
weight between 50-120 kg
ability to read, write and complete informed consent</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>drug sensitivity
drug dependence
neurologic disease
psychiatric illness
cardiac disease
liver disease
cardiac arrythmia
Diabetes
neuromuscular problem
inflammatory arthritis e.g. RA
renal disease</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intrarticular analgesic cocktail (MS, ropivacain, ketorolac, epinephrin) injection 100 cc</i_keyword>
      <i_keyword>Intervention group: periarticular injection of analgesic cocktail 100 cc</i_keyword>
      <i_keyword>Intervention group: intra (50cc) and peri articular (50 cc) injection of analgesic cocktail</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of post operative morphin sulfate injection after the total knee arthroplasty. Timepoint: during 72 hr after the total knee arthroplasty. Method of measurement: mg morphin injected by the nursery and documented in the patien's documents.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Visual analogue scale. Timepoint: during 72 h postoperatively 1 week and 1 months after surgery. Method of measurement: 1  to 10 based on the VAS scale.</sec_outcome>
      <sec_outcome>WOMAC. Timepoint: 1 DAY before OR, 1 week and 1 month after OR. Method of measurement: womac scale.</sec_outcome>
      <sec_outcome>KSS. Timepoint: 1 DAY before OR, 1 week and 1 month after OR. Method of measurement: KSS scale.</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>2021-01-27</approval_date>
        <contact_name>ethical review board of imam khomeini hospital, tehran university of medical sciences</contact_name>
        <contact_address>Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran1419733141, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
