<?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>IRCT20230204057318N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-19</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of erector spinae and the subfascial-subcutaneous blocks</public_title>
      <acronym></acronym>
      <scientific_title>Comparison analgesia of erector spinae plane block under ultrasound guidance and the combination of subfascial and subcutaneous ropivacaine blocks in open kidney donor nephrectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82718</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple randomization method will be used using Random Generator software. First, a set of random numbers will be generated, then eligible patients will receive a random number before anesthesia. Based on the assigned number, patients will be assigned to one of three study groups (numbers 1 to 35 were assigned to Group 1, numbers 36 to 70 to Group 2, and numbers 71 to 105 to Group 3), Blinding description: Participant information will be recorded and utilized exclusively using a numerical code to ensure that both their identity and the type of intervention remain unknown. Throughout all stages of data collection, outcome assessment, and statistical analysis, the research team members will only be exposed to these codes and will have no knowledge of the intervention type. (Allocation Concealment)
Participants will be unaware of which treatment group they are in. Nevertheless, all treatment methods in the study will be explained to each participant at the beginning when obtaining consent, and the apparent procedures will be identical for all groups, as patients will be under anesthesia during the procedure and the blocks do not create any visual difference for observation. (Blinding)
The clinical caregiver (surgeon and anesthesiologist) will only be aware of the type of intervention for the duration of its performance and will have no role in data collection or results analysis after the intervention.
The individual responsible for data collection and outcome assessment will only have access to each person’s random code and will be unaware of the group allocation and the type of intervention participants received.
The statistical analyst will conduct the data analysis with the coded data, without knowledge of the intervention type, to ensure the blinding process is maintained throughout the study.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain control after open nephrectomy in donors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Erector Spinae (ESPB) Group. After confirming landmarks and the correct injection site (T7–T9 vertebral levels, erector spinae muscle, transverse process), an ultrasound-guided in-plane technique will be performed using a 22G needle. The needle tip will be positioned on the transverse process of the vertebra. A local anesthetic (20 mL of 0.25% ropivacaine) will be injected. Intervention 2: Intervention Group 2: Surgeon-Administered Injection.  At the end of the surgery, before closing the fascia, the surgeon (the same individual for all patients) will inject 10 milliliters of 0.25% ropivacaine subfascially and 10 milliliters of 0.25% ropivacaine subcutaneously at the incision site. Intervention 3: In the control group, patients will receive only morphine at a dose of 0.1 mg/kg for pain relief without receiving any nerve 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 All data is potentially shareable after de-identifying individuals.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Shakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Hossein Hospital, Shahid Madani st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 7343 0000</telephone>
        <email>dr.alirezashakeri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maede Karimian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Modarres Hospital, Saadat Abad intersection, Yadgar Imam highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1998734383</zip>
        <telephone>+98 21 2207 4087</telephone>
        <email>m_karimian1990@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elective open nephrectomy for kidney donor
American Society of Anesthesiologists (ASA) physical status classification of I or II</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Anticoagulant agent use
Blood abnormality or coagulation disorders
Allergy history to local anesthetics
Patient refusal</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other acute postprocedural pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Erector Spinae (ESPB) Group. After confirming landmarks and the correct injection site (T7–T9 vertebral levels, erector spinae muscle, transverse process), an ultrasound-guided in-plane technique will be performed using a 22G needle. The needle tip will be positioned on the transverse process of the vertebra. A local anesthetic (20 mL of 0.25% ropivacaine) will be injected.</i_keyword>
      <i_keyword>Intervention Group 2: Surgeon-Administered Injection.  At the end of the surgery, before closing the fascia, the surgeon (the same individual for all patients) will inject 10 milliliters of 0.25% ropivacaine subfascially and 10 milliliters of 0.25% ropivacaine subcutaneously at the incision site.</i_keyword>
      <i_keyword>In the control group, patients will receive only morphine at a dose of 0.1 mg/kg for pain relief without receiving any nerve block.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>First time to analgesic demand. Timepoint: First timepoint for requesting analgesic. Method of measurement: Minutes based on a stopwatch.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total postoperative opioid consumption. Timepoint: Once after 24 hours after surgery. Method of measurement: The amount of opioid consumed by patients in the first 24 hours after surgery in milligrams (mg) and reported based on (Morphine Equivalent Dose - MED) from hospital medical records and data recorded in the PCA (Patient-Controlled Analgesia) pump.</sec_outcome>
      <sec_outcome>Postoperative pain. Timepoint: The measurement will be taken postoperatively in the recovery room, and at 6, 12, and 24 hours after surgery. Method of measurement: Visual analog scale.</sec_outcome>
      <sec_outcome>Number of times the patient requested analgesic medication. Timepoint: During the first 24 hours after surgery. Method of measurement: The number of times patients requested analgesic medication during the first 24 hours after surgery will be obtained from 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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-08</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Yaman st., Shahid Chamran Hwy. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
