<?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>IRCT20120915010841N25</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-09-20</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of csf aspiration in spinal anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of 0.2 ml of cerebro-spinal fluid aspiration at the end of intrathecal injection of bupivacaine 0.5% on the onset time and sensory block level in cesarean section under spinal anesthesia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58197</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we will use the quadruple Block Randomization method. For this purpose, we prepare four sheets of paper.Write the letter A on two sheets and the letter B on the other two sheets. Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets is randomly taken out and based on this sheet is A or B, it will be assigned to one of the two groups of aspiration and non-aspiration. After randomly pulling out all four sheets, all the papers are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached, Blinding description: The patients are placed under spinal anesthesia by an anesthesiologist in a sitting position and based on randomization , the patients undergoing aspiration or non-aspiration of cerebro-spinal fluid at the end of spinal anesthesia and then the vital signs, the level and quality of sensory and motor blocks were measured and recorded by Pinprick, VAS and bromage score by the researcher (intern) who has no information on randomization .</study_design>
      <phase>2-3</phase>
      <hc_freetext>Spinal anesthesia in cesarean sectionکد ICD-10خالی.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After receiving 10 ml per kg  of serum Ringer,  patients were placed in a sitting position and after determining the subarachnoid space with the entry of Quince spinal needle No. 25 at the level of L3-L4 or L4-L5 by an anesthesiologist 10 mg Bupivacaine 0.5% with 2.5 microgram of sufentanil is injected into the subarachnoid space.At the end of the drug injection, in group A (aspiration group), 0.2 ml of CSF is re-aspirated and re-injected into the subarachnoid space, then the spinal needle is removed and the patient is placed  in a supine position. Intervention 2: Control group: After receiving 10 ml per kg  of serum Ringer,  patients were placed in a sitting position and after determining the subarachnoid space with the entry of Quince spinal needle No. 25 at the level of L3-L4 or L4-L5 by an anesthesiologist 10 mg Bupivacaine 0.5% with 2.5 microgram of sufentanil is injected into the subarachnoid space. At the end of the drug injection, in group B (without aspiration), without CSF aspiration, the spinal needle is removed and then the patient is placed  in a 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>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 Because the study is not finished yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital, Pasdaran Street</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manuchehriann@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Manouchehrian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemieh Hospital, Pasdaran Street.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517789971</zip>
        <telephone>+98 81 3827 7012</telephone>
        <email>manuchehriann@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious consent to participate in the study
18 to 46 years old
Term pregnancy (37 weeks and more)
Candidate for cesarean section under spinal anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>46 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cancel the continuation of the plan
Heart and lung diseases, hypertension, diabetes, arrhythmia and heart failure
Multiple pregnancies
Eclampsia and preeclampsia
Contraindications of spinal anesthesia (high ICP, hypovolemia, anemia, coagulation disorders)
Emergency C/S</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After receiving 10 ml per kg  of serum Ringer,  patients were placed in a sitting position and after determining the subarachnoid space with the entry of Quince spinal needle No. 25 at the level of L3-L4 or L4-L5 by an anesthesiologist 10 mg Bupivacaine 0.5% with 2.5 microgram of sufentanil is injected into the subarachnoid space.At the end of the drug injection, in group A (aspiration group), 0.2 ml of CSF is re-aspirated and re-injected into the subarachnoid space, then the spinal needle is removed and the patient is placed  in a supine position.</i_keyword>
      <i_keyword>Control group: After receiving 10 ml per kg  of serum Ringer,  patients were placed in a sitting position and after determining the subarachnoid space with the entry of Quince spinal needle No. 25 at the level of L3-L4 or L4-L5 by an anesthesiologist 10 mg Bupivacaine 0.5% with 2.5 microgram of sufentanil is injected into the subarachnoid space. At the end of the drug injection, in group B (without aspiration), without CSF aspiration, the spinal needle is removed and then the patient is placed  in a supine position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Time to reach the maximum level of sensory block. Timepoint: Immediately after spinal anesthesia until the onset of sensory block. Method of measurement: Use the watch to measure time and the needle(pinprick) to determine the sensory block.</prim_outcome>
      <prim_outcome>Sensory block quality. Timepoint: Before surgery. Method of measurement: Visual Analog Scale(VAS).</prim_outcome>
      <prim_outcome>Motor block quality. Timepoint: Before surgery. Method of measurement: Bromage score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, and every 10 minutes until the end of the surgery. Method of measurement: Automatic non-invasive blood pressure device.</sec_outcome>
      <sec_outcome>Nausea and Vomiting. Timepoint: During and after surgery. Method of measurement: Observation.</sec_outcome>
      <sec_outcome>The amount of ephedrine have been consumed. Timepoint: During surgery. Method of measurement: mg.</sec_outcome>
      <sec_outcome>The amount of atropine have been consumed. Timepoint: During surgery. Method of measurement: mg.</sec_outcome>
      <sec_outcome>Spinal Failure. Timepoint: During surgery. Method of measurement: Pinprick.</sec_outcome>
      <sec_outcome>Heart Rate. Timepoint: Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery. Method of measurement: Pulse oximetry.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-24</approval_date>
        <contact_name>Ethics committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Mahdieh Street Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
