<?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>IRCT20200525047563N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of relative frequency of post-operative urinary retention in two methods of spinal analgesia with and without opioid.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of relative frequency of post-operative urinary retention in two methods of spinal analgesia with and without opioid.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48428</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method is used, which is done using a table of random numbers.To use the number of random numbers, we first determine the reading path of the table numbers (for example, top, bottom, left or right).Then we assume certain numbers for each group (for example, even numbers for intervention A and odd numbers for intervention B).Then we touch on one of the numbers and move in one of the predetermined directions and record the numbers and assign them to different groups, Blinding description: In this study, a person who is responsible for analyzing statistical data is not aware of the treatment process and study groups and the information is provided to that person in groups A and B. This helps the person's personal opinion not to affect the results.</study_design>
      <phase>3</phase>
      <hc_freetext>Lower limb Orthopedic surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:To perform spinal anesthesia in the first group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is placed sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then, the specialist doctor inserts a spinal needle of the appropriate size in the designated space and injects 1.5-2 cc of marcaine (0.05%, produced by   Cobel Darou) in addition to 25 micrograms of fentanyl. However, before injecting the drug, it is first pulled out of the liquid to ensure the correct location of the needle. Intervention 2: To perform spinal anesthesia in the second group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then the specialist doctor enters the spinal needle with the appropriate size in the prescribed space and injects 2.5-2 cc of marcaine (0.05% produced by Cobel Darou) in that place. However, before injecting the drug, it is first pulled out of the liquid a little to ensure the correct entry of the needle.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azadeh Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 2237 0673</telephone>
        <email>azi_emami@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azadeh Emami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 2237 0673</telephone>
        <email>azi_emami@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are candidates for lower limb orthopedic surgery
Patients are candidates for anorectal surgery</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of urinary problems
Patients with a history of diabetes
Pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y79.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Surgical instruments, materials and orthopedic devices (including sutures) associated with adverse incidents</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:To perform spinal anesthesia in the first group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is placed sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then, the specialist doctor inserts a spinal needle of the appropriate size in the designated space and injects 1.5-2 cc of marcaine (0.05%, produced by   Cobel Darou) in addition to 25 micrograms of fentanyl. However, before injecting the drug, it is first pulled out of the liquid to ensure the correct location of the needle.</i_keyword>
      <i_keyword>To perform spinal anesthesia in the second group, first fluid therapy with normal saline injection serum up to 300 cc is performed. Then the patient is sitting or lying on his side. We explain the procedure to the patient and ask the patient to work with the anesthesia nurse by taking the knees and giving the abdomen inwards and sticking the chin to the chest. By observing these points by the patient, the injection site is better observed and identified. The skin is then sterilized with a gas and betadine and sterilized with white alcohol. Then the specialist doctor enters the spinal needle with the appropriate size in the prescribed space and injects 2.5-2 cc of marcaine (0.05% produced by Cobel Darou) in that place. However, before injecting the drug, it is first pulled out of the liquid a little to ensure the correct entry of the needle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary retention. Timepoint: after surgery. Method of measurement: Ask the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complaints of incomplete urination. Timepoint: After surgery. Method of measurement: Ask the patient.</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>2020-05-18</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences., Hemmat Highway., Next to Milad Tower., Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
