<?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>IRCT20140427017455N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-25</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effects of adding different doses of tramadol to bupivacaine solution for brachial plexus block on postoperative analgesia duration after arthroscopic shoulder surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of different doses of adjuvant perineural tramadol to 0.25% bupivacaine in prolongation of postoperative analgesia in arthroscopic shoulder surgeries under interscalene block</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16061</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: simple, Unit of randomization: individual, Tools of randomization: Software, Allocation concealment: by the same software, Blinding description: Patients are blind
The researcher who injects the solution receives a prepared solution, therefore the researcher is blind. 
The care provider nurses in the operating room and the recovery room are blind.
The research team member who evaluates the patient is also blind.</study_design>
      <phase>3</phase>
      <hc_freetext>post shoulder arthroscopic surgery analgesia duration.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine with 100 mg tramadol in 15 milliliters volume in interscalene block. Intervention 2: Intervention group 2: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine with 200 mg tramadol in 15 milliliters volume in interscalene block. Intervention 3: Control group: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine in 15 milliliters volume in interscalene block.</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 Decision will be made later</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir Poya Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of anesthesiology, Imam Khomeini Hospital, Keshavarz Blvrd, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 4415 4251</telephone>
        <email>p_zanjani@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir Poya Zanjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qods St., Keshavarz Blv.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1516974144</zip>
        <telephone>+98 21 6658 1576</telephone>
        <email>p_zanjani@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients candidate for Shoulder arthroscopic surgery
Age 18 years or more
ASA class I-II
Intact cognition and contiousness</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient refusal
Contraindication for drug infiltration
History of Allergic reactions to drug used in this study
Contraindication for intrscalene block
Contraindication for tramadol administration
Opioid abuse history
Pregnancy or baby breast feeding
Chronic pain syndromes
Any neurological problem in the same side upper limb
History of epilepsy
Body mass index 40 or higher</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y45.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Opioids and related analgesics</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine with 100 mg tramadol in 15 milliliters volume in interscalene block</i_keyword>
      <i_keyword>Intervention group 2: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine with 200 mg tramadol in 15 milliliters volume in interscalene block</i_keyword>
      <i_keyword>Control group: Perineural injection of 0.25% bupivacaine and 1/200000 epinephrine in 15 milliliters volume in interscalene block</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain scores at recovery. Timepoint: 10 minutes after patient's admission to recovery. Method of measurement: Visual Analogue Scale VAS.</prim_outcome>
      <prim_outcome>Postoperative Pain Scores in the ward. Timepoint: 4, 8, 12, 18 and 24 hours post brachial plexus block. Method of measurement: Visual Analogue Scale VAS.</prim_outcome>
      <prim_outcome>Time to maximum postoperative pain score. Timepoint: during the first postoperative 24-hours. Method of measurement: Visual Analogue Scale VAS.</prim_outcome>
      <prim_outcome>Time to first rescue analgesic dose. Timepoint: During the first postoperative day. Method of measurement: First analgesic injection in ward based on patient's medical records.</prim_outcome>
      <prim_outcome>Total administered opioid during the first postoperative 24-hours. Timepoint: during the first postoperative 24-hours. Method of measurement: total administered opioid from admission to ward to 24 hours post plexus block, based on medical records.</prim_outcome>
      <prim_outcome>Total administered opioid in the recovery. Timepoint: During the recovery period. Method of measurement: total administered opioid during the recovery based on the patient's medical records.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Nausea. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.</sec_outcome>
      <sec_outcome>Vomiting. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.</sec_outcome>
      <sec_outcome>Seizure. Timepoint: Once at the end of surgery, and then at the end of the first post operative 24-hour. Method of measurement: Patients' medical records.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-05-28</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Scienses</contact_name>
        <contact_address>Qods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
