<?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>IRCT20210415050983N12</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-06-24</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Erector Spina Block with Ropivacaine and Erector Spina Block with Ropivacaine and Epinephrine on Intraoperative Bleeding and Duration of Analgesia in Posterior Lumbar Spine Fusion Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Erector Spina Block with Ropivacaine and Erector Spina Block with Ropivacaine and Epinephrine on Intraoperative Bleeding and Duration of Analgesia in Posterior Lumbar Spine Fusion Surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84057</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Permuted Randomized Blocks :In this method, 10 random blocks are generated by computer. Each block includes 5 people in the intervention group and 5 people in the control group. The order of these people is randomly arranged by computer and people are assigned to groups in the same way. At the end of each block, a new block of 10 is produced and this process will continue until the final sample volume is reached, Blinding description: Participants in the study are unaware of the groupings because the intervention is performed after anesthesia. The patient's clinical caregiver, the evaluator and recorder of the results, and the data analyzer are not aware of the grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Lumbar discopathy.</hc_freetext>
      <i_freetext>Intervention 1: Control group:  Control group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of 0.25% ropivacaine was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side. Intervention 2: Intervention group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of ropivacaine 0.25% and  5 mic/mL epinephrin was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side.</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 Restriction of some magazines to publish</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sogol Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Kargar St. Kamali St. Special Loghman Hakim Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5541 9005</telephone>
        <email>Drasgari98429@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sogol Asgari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>South Kargar St. Kamali St. Special Loghman Hakim Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1333635445</zip>
        <telephone>+98 21 5541 9005</telephone>
        <email>Drasgari98429@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients 18-65 years old are candidates for two or three level spine surgery
ASA score 1-2
Normal kidney and liver function
Patient consent to perform the block
No history of allergies to local anesthetics
No drug addiction
No diabetes</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Increase the scope of surgery to more than three level
Extending the length of surgery for more than 6 hours
Block site or systemic  infection
History of anticoagulant use</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M51.36</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other intervertebral disc degeneration, lumbar region</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>Control group:  Control group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of 0.25% ropivacaine was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side.</i_keyword>
      <i_keyword>Intervention group: After anesthesia and change of position to peron before surgery, in sterile conditions, using peripheral nerve block needle (stimuQuik, ARROW use) with sonosite-Nerve Ultrasound system under the erector spina block One-sided and each-sided injection of 20 ml of ropivacaine 0.25% and  5 mic/mL epinephrin was performed by a trained anesthesiologist in accordance with standard guidelines.A 5-8MHz liner probe is used for nerve block ultrasound guides. After selecting the target process transducer, the sagittal paramedic prop is placed about 2 cm outside the spinous processes so that the process transducer can be seen in the same direction. Insert the needle inplean the codal from the cranial to cudal until the tip of the needle hits the process transducer. 1-2 cc of local anesthetic is injected to ensure the correct location of the needle. If the location of the needle is suitable, the medicine is injected. The needle point is towards the posterior and inferior side.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intraoperative isoflurane Consumption in tow groups. Timepoint: Before the start of anesthesia and after the end of anesthesia. Method of measurement: By a graduated glass based on mL.</prim_outcome>
      <prim_outcome>Intraoperative fentanyl consumption in the two groups. Timepoint: End of surgery. Method of measurement: Dosage consumed based on mcg.</prim_outcome>
      <prim_outcome>Pain after surgery. Timepoint: 0, 1 , 6 , 12 and 24 hours after surgery. Method of measurement: Numeric Rating Scale(NRS).</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>2025-04-29</approval_date>
        <contact_name>Vice for Research and Technology, Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Velenjak, Yemen Street, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
