<?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>IRCT20221109056450N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of lateral position after spinal anesthesia on the consumption of narcotic drugs after surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lateral position after spinal anesthesia on the need for postoperative narcotics</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67259</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling will be done as a block randomization method. So, initially, in the Excel software, there are 6 blocks of 4 as (AA, BB), (BB, AA), (AB, BA), (BA, AB). (AB, AB), (BA, BA) are prepared and then these blocks will be arranged from one to six. A is the confirmation of the treatment or intervention group and B is the confirmation of the control group. Then one of these blocks will be randomly selected and based on the sequence of letters A and B in the selected block, the eligible people will be assigned to the treatment or control groups. The random process of selecting blocks and assigning people to the intervention and control groups will continue until the desired sample size is reached.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Complications of spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After spinal anesthesia, they undergo percutaneous nephrolithotomy surgery in the lateral position. Intervention 2: Control group: After spinal anesthesia, they undergo percutaneous nephrolithotomy in supine position.</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:
The whole data can be shared after unidentifiable people.

When:
Start the access period 6 months after printing the results

To whom:
Only available to scholars working in academic and academic institutions.

Conditions:
Employed in research centers

Where to obtain:
Person responsible for scientific inquiries

How to obtain:
Send email to person responsible for scientific inquiries (alirezajaffari@gmail.com)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza  Jaffari  MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9th Boostan Street, Pasdaran Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666663111</zip>
        <telephone>+98 21 23601</telephone>
        <email>alirezajaffari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza  Jaffari  MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9th Boostan Street, Pasdaran Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1666663111</zip>
        <telephone>+98 21 23601</telephone>
        <email>alirezajaffari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 and above
Candidate patients for percutaneous nephrolithotomy surgery
Candidate for spinal anesthesia
Patients with satisfaction to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of neurological diseases, diabetes, hypertension
History of drug and alcohol abuse
History of vascular disorders in the lower limbs
History of spine surgery
History of psychiatric diseases and psychological disorders
Patients dissatisfied with participation in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T88.59</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anesthesia.</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After spinal anesthesia, they undergo percutaneous nephrolithotomy surgery in the lateral position.</i_keyword>
      <i_keyword>Control group: After spinal anesthesia, they undergo percutaneous nephrolithotomy in supine position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain level. Timepoint: 15, 30, 45, 60, 95, 105 and 120 minutes after the surgery. Method of measurement: Visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe).</prim_outcome>
      <prim_outcome>The amount of narcotic drug consumption after the surgery. Timepoint: 15, 30, 45, 60, 95, 105 and 120 minutes after the surgery. Method of measurement: Patient file.</prim_outcome>
      <prim_outcome>The first time of narcotic drug use. Timepoint: After entering recovery and within 120 minutes after the surgery. Method of measurement: Patient file.</prim_outcome>
      <prim_outcome>Hemodynamic status of the patient. Timepoint: 15, 30, 45, 60, 95, 105 and 120 minutes after the surgery. Method of measurement: Non-invasive monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea and vomiting after the surgery. Timepoint: After entering recovery and within 120 minutes after the surgery. Method of measurement: Patient files.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-22</approval_date>
        <contact_name>Ethics committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Tabnak Street. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
