<?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>IRCT20191013045095N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-10</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>effect of continuous epidural and continuous paravertebral block on pain after knee arthroplasty surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study of the effect of two continuous epidural methods and continuous paravertebral block on pain after knee arthroplasty surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>39</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43040</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into two groups (n = 19) continuous epidural and continuous paravertebral block.
Patients were completely randomly divided into four groups of continuous epidural receiving and continuous paravertebral block by Blocked Randomization method.
Using the table of random numbers and quadratic blocks, the following conditions were obtained in which group A individuals received continuous epidural and group B individuals received continuous paravertebral block. Putting the four blocks together results in situations that are completely random and the patients are randomly divided, Blinding description: In order to blind and hide the samples for each patient, a special code is written inside the sealed envelope, which is opened only before the patient is anesthetized and only by the researcher and in complete secrecy, and informs the patient group.</study_design>
      <phase>3</phase>
      <hc_freetext>Degenerative joint disease.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Epidural block group In this trial, our treatment method was performed to reduce pain after knee replacement surgery.10 to 15 cc bupivacaine is 0.25%, which is injected epidurally. Intervention 2: Intervention group: Paravertebral block group is used as a treatment method to reduce pain after knee joint surgery.10 to 15 cc bupivacaine is 0.25% which is injected paravertebrally.</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 NO MORE DETAIL</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jam e jam hemmat tower . heidari moghadam st .  sardar jangal blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476661349</zip>
        <telephone>+98 21 4461 6943</telephone>
        <email>Sarazamaniaa@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sara zamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jam e jam hemmat tower . Heidari st . Sardar jangal blvd</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1476661349</zip>
        <telephone>+98 21 4461 6943</telephone>
        <email>Sarazamaniaa@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age between 40-70 years
ASA I , II
having the satisfaction of participating in the study</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>sensitivity to any of the drugs used in the study
Body mass index&gt;40
severe liver and heart disease
addiction or prolonged use of analgesics</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>Control group: Epidural block group In this trial, our treatment method was performed to reduce pain after knee replacement surgery.10 to 15 cc bupivacaine is 0.25%, which is injected epidurally.</i_keyword>
      <i_keyword>Intervention group: Paravertebral block group is used as a treatment method to reduce pain after knee joint surgery.10 to 15 cc bupivacaine is 0.25% which is injected paravertebrally.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain following joint changes leading to surgery and knee replacement. Timepoint: Immediately after the intervention 4 hours after the intervention 8 hours after the intervention 16 hours after the intervention 24 hours after the intervention. Method of measurement: Pain intensity with VAS scale numbered by a ruler on a scale of 0 to 10.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: 0. Method of measurement: Year.</sec_outcome>
      <sec_outcome>Sex. Timepoint: 0. Method of measurement: Male or female.</sec_outcome>
      <sec_outcome>Weight. Timepoint: 0. Method of measurement: Different number by kilogram.</sec_outcome>
      <sec_outcome>Side effects of anesthesia. Timepoint: 24 hours. Method of measurement: Patient symptoms.</sec_outcome>
      <sec_outcome>Side effects of mepridine. Timepoint: 24 hours. Method of measurement: Patient symptoms.</sec_outcome>
      <sec_outcome>Amount of mepridine. Timepoint: 24 hours. Method of measurement: By used dosage.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-03</approval_date>
        <contact_name>Ethics committee of iran university of medical sciences</contact_name>
        <contact_address>Jam e jam hemmattower  Heidari  moghadam St Sardar jangal Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
