<?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>IRCT20221126056613N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-27</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of combined intrathecal dexamethasone-bupivacaine with bupivacaine</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of combined intrathecal dexamethasone-bupivacaine with bupivacaine alone for spinal anesthesia in a cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68965</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients, using random allocation software, were randomly
divided into median and paramedian groups. By selecting the
simple randomization method in the randomization box and
entering the determined total sample size in this software,
numbers were given to the patients and the patients were
allocated into two groups according to computer-generated
numbers, Blinding description: The patients and the nurse who cares for participants during the trial will be blinded by the intervention and control groups. Written consent is obtained from patients, but at the same time, patients do not know whether they are in the placebo or intervention group.</study_design>
      <phase>3</phase>
      <hc_freetext>Duration of spinal analgesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle.  The patients of the intervention group received 12 mg of 0.5% hyperbaric bupivacaine and 8 mg preservative-free dexamethasone with the Dexadic brand name (2 ml), overall 5 ml volume intrathecally. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company. Intervention 2: Control group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. The control group received 12 mg of 0.5% hyperbaric bupivacaine diluted in preservative-free normal saline (2 ml) with the same appearance as dexamethasone. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company.</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 -</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Aliakbar Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad Street, Imam khomeini Hospital, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 915 341 6876</telephone>
        <email>nasiriali7@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Akbar Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ershad street, Imam Khomeini Hospital, Urmia Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 915 341 6876</telephone>
        <email>nasiriali7@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>21-40 aged pregnant women candidate for elective cesarean section
Patients with ASA I and ASA II Cesarean section by spinal anesthesia
Satisfaction to participate in the project
Patients with stable vital signs
Women with second to fifth childbirth</inclusion_criteria>
      <agemin>21 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Women with stillbirth history
The presence of a clear anomaly in the fetus
Pregnancy complications (previa, accreta, preeclampsia, placental abruption, etc.)
Depression or proven mental disorder in pregnant women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O74.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other complications of anaesthesia during labour and delivery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle.  The patients of the intervention group received 12 mg of 0.5% hyperbaric bupivacaine and 8 mg preservative-free dexamethasone with the Dexadic brand name (2 ml), overall 5 ml volume intrathecally. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: Spinal anesthesia was performed in the sitting position at L4 -L5 level through a midline approach using a 25-gauge Quincke spinal needle. The control group received 12 mg of 0.5% hyperbaric bupivacaine diluted in preservative-free normal saline (2 ml) with the same appearance as dexamethasone. The drug was made available to the researchers of this project by Caspin Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The sensory level of the block. Timepoint: Measuring the patient's sensory block level at intervals of 1 minute to 20 minutes and then during and after surgery at intervals of 10 minutes until reaching T10. Method of measurement: It was examined bilaterally with the tip of the spinal needle along the midaxillary line.</prim_outcome>
      <prim_outcome>The motor level of the block. Timepoint: Measuring the patient's motor block level at intervals of 1 minute to 20 minutes and then during and after surgery at intervals of 10 minutes until reaching T10. Method of measurement: The motor block was assessed using the Modiﬁed Bromage scale.</prim_outcome>
      <prim_outcome>Pain assessment. Timepoint: After the sensory level returned to T10, every 30 minutes, the patient's pain sensation in the surgical site, abdomen and pelvis will be evaluated with the help of VAS score until the time of reaching 6 ≥ VAS score will be recorded. Method of measurement: Visual analog pain scale (VAS).</prim_outcome>
      <prim_outcome>Side effecs of anesthesia. Timepoint: The side effects of anesthesia will be measured after surgery for one week (the first two days every 8 hours and until the end of the week once a day). Method of measurement: By visual sign.</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-04</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia University of Medical Sciences; Resalat street; Jahad Blvd; Urmia; Iran. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
