<?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>IRCT20230829059295N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-08</date_registration>
      <primary_sponsor>Combined military hospital</primary_sponsor>
      <public_title>Comparison of trasnversus abdominis plane block and epidural in abdominal surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of analgesic efficacy between transversus abdominis plane block and epidural following abdominal surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72457</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Lottery method was used for randomization of patients in to two groups i.e One group that received TAP block and the other that had epidural anesthesia. Allocation concealment was not done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post operative pain relief after abdominal surgeries.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Transversus Abdominis Plane (TAP) Block group.  In the TAP block group (n=60), once the surgery was completed, a pain consultant performed the block under ultrasound guidance using standard technique furnished by NYSORA 11 . Bilateral TAP block was performed in all patients that underwent abdominal surgery and 15 ml of 1%lignocaine with adrenaline was injected on each side of the block. Intervention 2: Intervention group: Epidural analgesia group. An 18 G Smith epidural catheter Touhy needle was inserted in the epidural group (n=60) by a consultant anesthetist pre-operatively under aseptic measures with patient in the sitting position in the T6 thoracic space. Confirmation of correct placement was checked by hanging drop method and further confirmed by test dose of 5 ml 2% lignocaine with adrenaline. Once correct placement was confirmed, the catheter was secured, and surgery was started. No bolus dose of epidural was till the surgery was completed. At the end of surgery, a top-up of 10 ml of0.125% bupivacaine was given in the epidural catheter for post-op analgesia and pain relief.</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:
All collected data could be provided

When:
Data will be available for 2 years starting from October  2023 to October 2025

To whom:
Academic institutions

Conditions:
Interventionaal studies being done on the same topic

Where to obtain:
haroontariq299@gmail.com

How to obtain:
Please contact on the email provided to ask for detailed data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Haroon Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 323 7399976</telephone>
        <email>haroontariq299@gmal.com</email>
        <affiliation>Combined Military Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Haroon Tariq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>House No 318, Street 5, Sector B1, DHA Phase 1, Rawalpindi</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 323 7399976</telephone>
        <email>haroontariq299@gmal.com</email>
        <affiliation>Combined Military Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All ASA-I and II patients
Patients between ages 20-60 years
Patients undergoing for elective or emergency abdominal laparotomy.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with cancer, tumors or metastatic disease, low ejection fraction, respiratory compromise, post chemotherapy and coagulation disorders,
Allergic to bupivacaine or lignocaine
Unwilling to be included in the study
Patchy or failed epidural insertion and failure to perform TAP block after three unsuccessful attempts.
Infection at site of block</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 - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Transversus Abdominis Plane (TAP) Block group.  In the TAP block group (n=60), once the surgery was completed, a pain consultant performed the block under ultrasound guidance using standard technique furnished by NYSORA 11 . Bilateral TAP block was performed in all patients that underwent abdominal surgery and 15 ml of 1%lignocaine with adrenaline was injected on each side of the block..</i_keyword>
      <i_keyword>Intervention group: Epidural analgesia group. An 18 G Smith epidural catheter Touhy needle was inserted in the epidural group (n=60) by a consultant anesthetist pre-operatively under aseptic measures with patient in the sitting position in the T6 thoracic space. Confirmation of correct placement was checked by hanging drop method and further confirmed by test dose of 5 ml 2% lignocaine with adrenaline. Once correct placement was confirmed, the catheter was secured, and surgery was started. No bolus dose of epidural was till the surgery was completed. At the end of surgery, a top-up of 10 ml of0.125% bupivacaine was given in the epidural catheter for post-op analgesia and pain relief.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Patient satisfaction regarding post operative pain. Timepoint: At 24 hours. Method of measurement: Likert Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Adverse effects of analgesia. Timepoint: Within 24 hours. Method of measurement: Patient's subjective complaints.</sec_outcome>
      <sec_outcome>Effect on HDU stay due to pain. Timepoint: 24 hrs, 36hrs, 48 hrs. Method of measurement: Duration of admission in HDU.</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>Combined military hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-30</approval_date>
        <contact_name>Ethical committee of combined military hospital</contact_name>
        <contact_address>Tamizudin road , lalkurti rawalpindi Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
