<?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>IRCT201306307984N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-09-11</date_registration>
      <primary_sponsor>Tehran university of medical sciences, Vice-chancellor for research</primary_sponsor>
      <public_title>Comparing the effect of  Pulsed and Conventional  Radiofrequency celiac plexus neurolysis on Abdominal Cancer Pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of  Pulsed and Conventional  Radiofrequency celiac plexus neurolysis on Abdominal Cancer Pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-05-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Abdominal cancers.</hc_freetext>
      <i_freetext>Intervention 1: The patients are first divided into 2 groups each containing 25 persons. In the first group or the PRF group, celiac plexus block would be performed under fluoroscopy and sterile condition after placing the patient on prone position on the OR table. All the patients should have IV line and pulse-oxymetry plus blood pressure and ECG monitoring. The target point is on the anterolateral part of the first lumbar vertebrae. After prep and drape of the skin, a skin wheal would be made by injection of Lidocaine 2 %( 5 ml) into the subcutaneous tissues. The C-arm will be placed in 30 degrees ipsilateral oblique position and the 150 mm RF cannula with 10 mm active tip will be introduced in tunnel vision towards the L1 vertebral body. In the lateral view the needle tip should reach 1-2 centimeter in front of the L1 body. Then 2 ml contrast media (Visipaque 270 mg/dl) would confirm the correct position and 5 ml Ropivacaine 0.5 % ( long-acting local anesthetic) would be injected. Afterwards the Radiofrequency waves in the pulsed mode at 42 degrees and for two cycles of 15 minutes would be started with an interval of 30 seconds between the two. Intervention 2: In the second group the same method is used except for the final stage for which the conventional mode with RF cycles of 90 degrees and for 90 seconds will be used twice with an interval of 30 seconds. At the end of the procedure, the patients will be transferred to the recovery room and they will be discharged if no complication occurs after2 hours.</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>Dr Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of anesthesiology and pain Rsoul-Akram Medical Center,4th floor, number 7, Niyayesh St, Sattar Khan Av</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2107</telephone>
        <email>farimani@tums.ac.ir</email>
        <affiliation>Tehran university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Farnad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of anesthesiology and pain Rsoul-Akram Medical Center,4th floor, number 7,  Niyayesh St, Sattar Khan Av</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2107</telephone>
        <email>farimani@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Iinclusion criteria:  Age range of 20 to 60 years old ; painful non-operable abdominal cancer&#13;
 Exclusion criteria: Renal failure; Pregnancy; Allergy to Ropivacaine and Opioid; Significant coexisting disease (CNS or cardiovascular problems)</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C25.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of pancreas</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The patients are first divided into 2 groups each containing 25 persons. In the first group or the PRF group, celiac plexus block would be performed under fluoroscopy and sterile condition after placing the patient on prone position on the OR table. All the patients should have IV line and pulse-oxymetry plus blood pressure and ECG monitoring. The target point is on the anterolateral part of the first lumbar vertebrae. After prep and drape of the skin, a skin wheal would be made by injection of Lidocaine 2 %( 5 ml) into the subcutaneous tissues. The C-arm will be placed in 30 degrees ipsilateral oblique position and the 150 mm RF cannula with 10 mm active tip will be introduced in tunnel vision towards the L1 vertebral body. In the lateral view the needle tip should reach 1-2 centimeter in front of the L1 body. Then 2 ml contrast media (Visipaque 270 mg/dl) would confirm the correct position and 5 ml Ropivacaine 0.5 % ( long-acting local anesthetic) would be injected. Afterwards the Radiofrequency waves in the pulsed mode at 42 degrees and for two cycles of 15 minutes would be started with an interval of 30 seconds between the two.</i_keyword>
      <i_keyword>In the second group the same method is used except for the final stage for which the conventional mode with RF cycles of 90 degrees and for 90 seconds will be used twice with an interval of 30 seconds. At the end of the procedure, the patients will be transferred to the recovery room and they will be discharged if no complication occurs after2 hours</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Visual analogue score according to the designed pain ruler. Timepoint: Weekly for 3 consecutive months. Method of measurement: Visual analogue score is measured with a marked ladder from 0 to 10.</prim_outcome>
      <prim_outcome>The amount of analgesic used. Timepoint: Weekly for 3 consecutive months. Method of measurement: The percentage of the used analgesic is measured by dividing the amount of analgesic after the block by the amount before the block and then multiplying the result by 100.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure changes. Timepoint: Before the intervention and 3 weeks thereafter. Method of measurement: Measured with digital sphygmomanometer.</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>Tehran university of medical sciences, Vice-chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-05-06</approval_date>
        <contact_name>Ethics committee of Tehran university of medical sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences (TUMS), 4th floor, Corner Ghods St.,  Keshavarz Blv,Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
