<?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>IRCT20250325065151N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-23</date_registration>
      <primary_sponsor>Jinnah Postgraduate Medical Center</primary_sponsor>
      <public_title>Use of two different local anesthetic drugs Bupivacaine and Tramadol together compared with only using Bupivacaine for post operative pain management</public_title>
      <acronym></acronym>
      <scientific_title>Use of Bupivacaine with Tramadol is better than use of only Bupivacaine for post operative pain in Local Anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82589</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method (Lottery method) will be used.
Unit of randomization will be individual.
Randomization strata in stratified randomization will not be applicable.
The tool used will be paper slips drawn randomly from a container. Other tools like a computer software will not be used.
The random sequence will be generated by drawing lots (paper slips) from a shuffled container.
Allocation concealment will be carried out, Blinding description: In this study, single blinding will be implemented by ensuring that the patients (participants) are unaware of the treatment they received.


The patients will be randomly assigned to either the Bupivacaine alone group or the Bupivacaine + Tramadol group using the lottery method.
The anesthetic solutions will be prepared in identical syringes to prevent the patients from distinguishing between the two treatments.
The patients will not be informed about which anesthetic they received, reducing the risk of reporting bias based on expectations.
However, the researchers administering the anesthesia will be aware of the treatment assignments.</study_design>
      <phase>3</phase>
      <hc_freetext>Postoperative Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: patients received 0.5 ml/kg of 0.25% bupivacaine in combination with 1 mg/kg of tramadol. Intervention 2: Control group: patients received 0.5 ml/kg of 0.25% plain bupivacaine only.</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 Due to institutional policies and ethical considerations regarding patient confidentiality, the deidentified individual participant data (IPD) from this study will not be shared. Additionally, the scope and scale of the study do not necessitate public IPD sharing, and all relevant findings have been adequately presented in the published results.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Moosa Ashfaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafiqui (H.J.) Shaheed Road, Karachi</address>
        <city>karachi</city>
        <country1>Pakistan</country1>
        <zip>75510</zip>
        <telephone>+92 21 35380228</telephone>
        <email>moosanl30@gmail.com</email>
        <affiliation>Jinnah Sindh Medical University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Syeda Zarreen Raza</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rafiqui Shaheed Road, Karachi Cantonment</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>75510</zip>
        <telephone>+92 21 35380228</telephone>
        <email>zarreen.raza@jsmu.edu.pk</email>
        <affiliation>Jinnah Postgraduate Medical Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients undergoing elective procedure under local anesthesia
Both genders
Age 18-60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Procedures under general anesthesia
Diabetic patients, assessed by history and clinically and HbA1c &gt;6.5%
Patients with metastatic disease, assessed by history, clinically and by imaging
Patients who are I/V opioid abusers will be excluded.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: patients received 0.5 ml/kg of 0.25% bupivacaine in combination with 1 mg/kg of tramadol</i_keyword>
      <i_keyword>Control group: patients received 0.5 ml/kg of 0.25% plain bupivacaine only</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean postoperative pain score. Timepoint: 4,8 and 24 hours after intervention. Method of measurement: Visual Analog Scale.</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>Jinnah Postgraduate Medical Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-05</approval_date>
        <contact_name>Ethics committee of Jinnah Postgraduate Medical Center</contact_name>
        <contact_address>Rafiqui Shaheed Road, Karachi Cantonment Karachi Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
