<?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>IRCT20170423033615N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Interscalen brachial plexus blockade combined with Perineural dexamethasone for post operative analgesia after shoulder surgery</public_title>
      <acronym></acronym>
      <scientific_title>Interscalen brachial plexus blockade combined with Perineural dexamethasone for post operative analgesia after shoulder surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this method, based on the table of random numbers, first the number of samples is entered using a computer, and for each patient  two-digit code is assigned . The researcher randomly selects a point in the Weston line. If the number is smaller than the sample size, the selection is made. And this continues until the sample size is complete, Blinding description: In this research, the drugs of the case group and the control group are drawn into the syringe by the nurse anesthetist. Therefore, the nurse is aware of the types of drugs of the two groups. The researcher, who is an anesthesiologist, does not know which group the drug belongs to. So the researcher is blind at this stage. On the other hand, the participants of the study are also blind to the difference of drugs in each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>post operation pain in shoulder surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group,the combination of lidocaine 1.5% in the amount of 2 cc, bupivacaine 0.5% in the amount of 2 cc (20 mg), and 2 cc of dexamethasone (8 mg) are injected between the roots of C5-C6 cervical spine. Intervention 2: Control group: the combination of 30 cc lidocaine1.5%, 2cc bupivacaine 0.5%(20mg), and 2cc of normal saline are injected between the C5-C6 roots of spine.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information on the initial implications

When:
since 2023

To whom:
Researchers working in academic institutions

Conditions:
There are no special conditions

Where to obtain:
Mahshid Ghasemi MD,  mahshidghasemi@sbmu.ac.ir

How to obtain:
Send a request by e-mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahshid Ghasemi MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pain Clinic, Akhtar Hospital, Shariati str, Sharifi Manesh Ave</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1964714953</zip>
        <telephone>+98212201072</telephone>
        <email>mahshidghasemi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahshid Ghasemi MD</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pain Clinic, Akhtar Hospital, Shariati str, Sharifi Manesh Ave</address>
        <city>TEHRAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1964714953</zip>
        <telephone>98212201072</telephone>
        <email>mahshidghasemi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA I , ASA II
Candidate for shoulder surgery
No substance abuse in the past 6 weeks
No orthopedic surgery in the lower limb under spinal anesthesia
no respiratory diseases, diabetes; Cardiovascular
no drug addiction according to definition
Normal body temperature
No history of shivering
No history of seizures
Absence of tremors or Parkinson's
Not taking NSAIDs 24 hours before surgery
Absence of infection or wound
No Allergy to local anesthetics
Not pregnant and breastfeeding
Duration of surgery maximum 3 hours
No allergy to Estroids</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of psychiatric disorders
patient refusal or inability to give informed consent
ASA class III and above
anticoagulants
History of adverse reactions to steroids
History of adverse reactions to local anesthetics
History of drug abuse
Occurrence of complications that require intervention within 24 hours after the operation
receiving blood transfusion during surgery or anesthesia
central body temperature to less than 32 degrees Celsius during surgery</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>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group,the combination of lidocaine 1.5% in the amount of 2 cc, bupivacaine 0.5% in the amount of 2 cc (20 mg), and 2 cc of dexamethasone (8 mg) are injected between the roots of C5-C6 cervical spine.</i_keyword>
      <i_keyword>Control group: the combination of 30 cc lidocaine1.5%, 2cc bupivacaine 0.5%(20mg), and 2cc of normal saline are injected between the C5-C6 roots of spine</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 12 hours after the operation, 24 hours after the operation. Method of measurement: VAS Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-12</approval_date>
        <contact_name>Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences</contact_name>
        <contact_address>Shahid Abbas Arabi Street, Shahid Beheshti University Of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
