<?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>IRCT20180921041078N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-12-26</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>effectiveness between lidocain and meperidin in anal fissure</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the success rate of spinal anesthesia with lidocaine and spinal anesthesia with meperidine in anal fissure surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34361</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The anesthesiologist performs spinal anesthesia with lidocaine and pethidine as one of the patients, and the surgeon does not know how the drug is used in spinal anesthesia.
Also a surgical nurse who does not know how to operate (blind sampling), Blinding description: lack of patients awareness
lack of surgeon awareness to plan of spinal anesthesia.</study_design>
      <phase>3</phase>
      <hc_freetext>chronic anal fissure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The patient is placed in a sitting position after rinsing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid out The spinal cord is used from the end of a 25 mg pethidine needle. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation. Intervention 2: Control group: The patient is placed in a sitting position after washing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid exit Spinal cord From the end of the needle of lidocaine drug 0.5 ml of 5% lidocaine is used. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation.</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 Final incompletness</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Rezaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General surgeon official,Alzahra hospital,Isfahan town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 1668 5555</telephone>
        <email>ali_medi_84@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Safaee Masome MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>General surgeon official, Alzahra hospital,Isfahan town</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 1668 5555</telephone>
        <email>safaee.masumeh@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>all patients with anal fissure</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction with spinal anesthesia
infection site of spinal anesthesia
coagolopathy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K60.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic anal fissure</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: The patient is placed in a sitting position after rinsing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid out The spinal cord is used from the end of a 25 mg pethidine needle. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation.</i_keyword>
      <i_keyword>Control group: The patient is placed in a sitting position after washing the back with betadine solution of 24-gauge Quinke spinal needle No. 24 (24-gauge Quinke spinal needle) enters the intrathecal space between the fourth and fifth lumbar vertebrae and after confirming the intrathecal space with fluid exit Spinal cord From the end of the needle of lidocaine drug 0.5 ml of 5% lidocaine is used. The patient remains seated for 5 minutes and then the patient is placed in a suitable position (lithotomy) to perform the relevant operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sphincter tone in spinal anesthesia with meperidine compared to spinal anesthesia with lidocaine. Timepoint: During the anal fissure surgery. Method of measurement: Anal manometry.</prim_outcome>
      <prim_outcome>Comparison of mean pain score in 2 hours. 4, 6, 12 and 24 after surgery based on NSR questionnaire in spinal anesthesia with lidocaine and meperidine. Timepoint: after surgery. Method of measurement: NSR questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the frequency distribution of lidocaine-induced complications with meperidine-induced complications during and after surgery in two methods of spinal anesthesia with lidocaine and spinal anesthesia with meperidine. Timepoint: During and after surgery. Method of measurement: NSR questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Research and Technology Official</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-11</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Sofe ave ,Alzahra hospital,Isfahan town (General surgeon official) Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
