<?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>IRCT2016120431225N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-12</date_registration>
      <primary_sponsor>Vice Chancellor for research of Iran University of Medical Sciences</primary_sponsor>
      <public_title>Transverse muscle block effect in analgesia after cesarean section</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of the duration of analgesia following two method of posterior and lateral transverse abdominal blocks under ultrasound guidance after cesarean section</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24608</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: To create analgesia in the lower abdomen after surgery, there are two main ways that we decided to compare the efficacy of both.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute pain after cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Posterior TAP block (quaderotus lumbrum) in the triangular space of petit (iliac crest and the inferior margin of the posterior border of the latissimus dorsi muscle and anterior of external oblique muscle).  When the probe was in posterior axillary position (the exact location of the posterior block quaderotus Lombrum), sono anatomy at the first stage showed transverse abdominis and then internal and external oblique that were doing aponeurosis. Needle(number 23 dr japan) was inserted at the junction of abdominal and quaderotus lombrum muscles and 15 cc bupivacaine 0.25%(maylan made in france) was injected bilaterally. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels. Intervention 2: Intervention group 2: lateral tap block was performed through the local injection of 15 cc anesthetic bupivacaine 0.25% using 23 gauge spinal needle (dr japan) at the junction of midaxillary line and transverse umblical line (between Coastal margin and iliac crest) between internal oblique and transverse abdominis muscles. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels.</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>Poupak Rahimzadeh(MD)</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21665173419</telephone>
        <email>Poupak_rah@hotmail.com</email>
        <affiliation>Rasoul Akram Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Poupak Rahimzade(MD)</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool Akram Hospital, Next to Mansouri street, Niayesh street, Sattar khan street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21665173419</telephone>
        <email>Poupak_rah@hotmail.com</email>
        <affiliation>Rasool Akram Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 18-50 year old females who are candidate for spinal anesthesia for elective and emergency cesarean section due to fetal distress; patients with ASA 1 &amp; 2. Exclusion criteria: patients with ASA&gt;3 &amp; 4; contraindication for the use of spinal anesthesia; Emergent conditions due to organic problems such as eclampsia, preeclampsia, placenta previa and ...; history of allergy to bupivacaine; receiving an analgesic; BMI&gt; 40; pre-pregnancy weight less than 50 kg; patients with an underlying disease or history of renal or liver disease or coagulopathy; prediction of spinal anesthesia unsuccessfulness (including inadequate anesthetic level); patients who have received sedation drugs  fentanyl 100 macrograms and midazolam 2 miligrams during the procedure.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Posterior TAP block (quaderotus lumbrum) in the triangular space of petit (iliac crest and the inferior margin of the posterior border of the latissimus dorsi muscle and anterior of external oblique muscle).  When the probe was in posterior axillary position (the exact location of the posterior block quaderotus Lombrum), sono anatomy at the first stage showed transverse abdominis and then internal and external oblique that were doing aponeurosis. Needle(number 23 dr japan) was inserted at the junction of abdominal and quaderotus lombrum muscles and 15 cc bupivacaine 0.25%(maylan made in france) was injected bilaterally. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels.</i_keyword>
      <i_keyword>Intervention group 2: lateral tap block was performed through the local injection of 15 cc anesthetic bupivacaine 0.25% using 23 gauge spinal needle (dr japan) at the junction of midaxillary line and transverse umblical line (between Coastal margin and iliac crest) between internal oblique and transverse abdominis muscles. The time of injection was immediately after cesarean section and when the anaesthesia had dropped 2 to 3 levels.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Satisfaction of Analgesia. Timepoint: Immediately after the caesarean section and at 2, 4, 6, 12, 24 and 36 hours after intervention. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time of first opioid analgesic injection. Timepoint: The first time analgeic request by the patient. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Pain relief score at rest. Timepoint: 2, 4, 6, 12, 24, 36 hours after intervention. Method of measurement: Pain Score Questionnaire (zero to ten).</sec_outcome>
      <sec_outcome>Patient satisfaction score. Timepoint: 36 hours after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Nausea and vomiting complaint. Timepoint: 2, 4, 6, 12, 24, 36 hours after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Amount of opioid consumption (mg). Timepoint: 36 hours after intervention. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Pain relief score when coughing. Timepoint: 2, 4, 6, 12, 24, 36 hours after intervention. Method of measurement: Pain Score Questionnaire (zero to ten).</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>Vice Chancellor for research of Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-20</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University Of Medical Sciences, Next to Milad tower, Hemmat highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
