<?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>IRCT20141001019359N17</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-19</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effectiveness of Pregabalin with Pregabalin-Paracetamol on postoperative pain</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of Pregabalin with Pregabalin-Paracetamol on postoperative pain Lumbar discectomy surgery; A Randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62817</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Double-Blind randomized clinical trial, Phase 3 on 60 patients, Web-Based randomization software was used for randomization, Randomization description: Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 4. So that in each block, there are 2 people in the first group (A), two people in the second group (B). After a random sequence was identified in all blocks, cards were written by writing A and B to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 60 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group, Blinding description: None of the participants in the study will be aware of the randomization list and also to apply allocation concealment randomization, the groups are placed in closed envelopes in the admission section and eligible individuals who enter the study are included respectively. In this study, there is a placebo (normal saline) for paracetamol, patients don't know whether it is paracetamol or a placebo. Also, the clinical caregiver and the person evaluating the outcome are also aware of the interventions, but they don't know about patient's allocation. Thus, the patient, clinical caregiver, evaluator and data analyst are blinded to the study groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1 : The intervention will be one hour before the operation, receive a single dose of 300 mg Pregabalin orally and 100 cc of 0.9% normal saline by infusion 30 minutes before surgery. Intervention 2: Intervention group 2: The intervention will be that one hour before the operation, they receive a single dose of Pregabalin 300 mg orally and receive 1 gram of Paracetamol per 100 cc of normal saline 0.9% diluted by infusion 30 minutes before the end of the surgery.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Shahinfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Ali Hospital, Shahriyar Ave, Bojnurd, Iran</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9416678894</zip>
        <telephone>+98 58 3229 6966</telephone>
        <email>dr.jshahinfar@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Shahinfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Bojnurd, Iran</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9416678894</zip>
        <telephone>+98 58 3229 1910</telephone>
        <email>dr.jshahinfar@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 to 60 years
ASA physical status I-II
Do not have drug addiction
Do not have allergic to Pregabalin and Paracetamol</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the patient have used paracetamol or pregabalin 48 hours before the operation.
If the patient be suffering from neurological and psychological, heart, lung, kidney and liver disease.
If the patient has any history of epilepsy.</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>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1 : The intervention will be one hour before the operation, receive a single dose of 300 mg Pregabalin orally and 100 cc of 0.9% normal saline by infusion 30 minutes before surgery.</i_keyword>
      <i_keyword>Intervention group 2: The intervention will be that one hour before the operation, they receive a single dose of Pregabalin 300 mg orally and receive 1 gram of Paracetamol per 100 cc of normal saline 0.9% diluted by infusion 30 minutes before the end of the surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Recovery, 12, 24 and 48 hours after surgery. Method of measurement: Visual Analog Score (VAS) Form of pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pregabalin and Paracetamol Side Effects. Timepoint: Up to 48 hours after surgery. Method of measurement: Examination and observation of the patient.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-14</approval_date>
        <contact_name>Ethics committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
