<?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>IRCT2012101711147N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-11</date_registration>
      <primary_sponsor>Birjand University of Medical Sciences, Vice Chancellery for Research and Information Technology</primary_sponsor>
      <public_title>Effects of two spinal anesthesia approaches  in the incidence of headache, backache, and regression of sensory level after operation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of median and paramedian approaches to spinal anesthesia in terms of the incidence of headache and backache, and the regression of spinal sensory level in patients undergoing elective cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>138</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>elective caesarean section.</hc_freetext>
      <i_freetext>Intervention 1: In the first group, a 23- gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg /Kg is injected into the subarachnoid space for spinal anesthesia with median approach (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted from superior boarder of spinous process of inferior vertebra in the midline of the selected space). Intervention 2: In the second group, a 23-gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg/Kg is injected into the subarachnoid space (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted 1 cm external and 0.5 cm inferior into the selected space with 20 degrees toward the L4-L5 vertebra).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Sharifzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice Chancellery of Research and Information Technology, Birjand University of Medical Sciences, Ghaffari Street</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9717853577</zip>
        <telephone>+98 56 1443 1183</telephone>
        <email>rezamood@yahoo.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shima Sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 3, Niloofar St., Sajjad Blvd</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1764 7230</telephone>
        <email>shimasheibany@yahoo.com</email>
        <affiliation>Mashad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1- All patients in ASA I and II classes aged 18-45, &#13;
2- indication of spinal anesthesia (lack of peripheral neuropathy, needle insertion site infection, coagulopathy)&#13;
&#13;
Exclusion criteria:&#13;
1- patients of above ASA I and II classes&#13;
2- Chronic back pain and headache&#13;
3- General anesthesia concurrent with spinal&#13;
4- puncture of the dura mater more than one time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O82.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Delivery by elective caesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group, a 23- gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg /Kg is injected into the subarachnoid space for spinal anesthesia with median approach (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted from superior boarder of spinous process of inferior vertebra in the midline of the selected space).</i_keyword>
      <i_keyword>In the second group, a 23-gauge blue needle is inserted at the L4-L5 vertebral level, and lidocaine 5% in a dose of 0.7-1 mg/Kg is injected into the subarachnoid space (Lidocaine: trade name: Xylocaine, chemical composition: 2-6 dimethyl phenyl, manufactured by Iranian Medicinal Company of Daroo Pakhsh). (In this approach, the spinal needle is inserted 1 cm external and 0.5 cm inferior into the selected space with 20 degrees toward the L4-L5 vertebra).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Backache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure backache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.</prim_outcome>
      <prim_outcome>Headache. Timepoint: in the recovery room, every 2 hours after operation; in the ward, every 4 hours after surgery up until 48 hours. Method of measurement: The visual analogue scale (VAS) standard questionnaire will be used to measure headache. In this method, a line with the length of ten centimeters will be used for which one end presupposes numbness and the other end presupposes the worst possible pain. The patient should mark this line to indicate his/her pain severity.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Regression of sensory level. Timepoint: 10 minutes to 2 hours after surgery in the recovery room. Method of measurement: sensation of coldness and light touch by alcohol.</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>Birjand University of Medical Sciences, Vice Chancellery for Research and Information Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-10-06</approval_date>
        <contact_name>Ethics Commitee of  Birjand University of Medical Sciences</contact_name>
        <contact_address>Birjand University of Medical Sciences, Ghaffari Street Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
