<?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>IRCT20200718048125N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-14</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of adding lidocaine to morphine on pain intensity after unilateral knee prosthesis surgery</public_title>
      <acronym>PCA</acronym>
      <scientific_title>Evaluation of adding Lidocaine to Morphine in patient controlled analgesia on pain intensity after unilateral knee prosthesis surgery by spinal anesthesia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64380</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used. We assign an A and B code to each anesthetic intervention. With the lottery method, patients will be placed in one of two codes. In this way, 29 codes A and 29 codes B are written on the paper and each paper is placed inside a special non-transparent sealed envelope and the envelopes are randomly placed on top of each other. Upon the entry of each qualified patient, an envelope is returned by the anesthesiologist to that patient and according to the code written on the paper inside, the anesthetic method is applied, Blinding description: In this study, patients are placed in two separate groups, A and B, which have the same drug composition except for one type of drug, and drugs with the same shape and packaging are injected to the patients through a patient controlled analgesia pump. The patient does not know whether he is in the control group or the intervention group. The personnel cooperating in the plan do not know the content of the pain pump. The researcher also has no knowledge of which group each patient is in and only analyzes the information.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Osteoarthritis of knee.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Spinal anesthesia; 25-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 mg of Adrenaline was injected at either the third or fourth lumbar epidural space with median or paramedian approach. The content of the patient controlled analgesia pump attached to the patient included 20 mg of morphine, 8 mg of Ondansetron ampoule (4 cc), 1g of Apotel (6.7 cc) and the rest of normal saline to reach a total volume of 100 cc. Intervention 2: Intervention group: Spinal anesthesia; 25-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 mg of Adrenaline was injected at either the third or fourth lumbar epidural space with median or paramedian approach. The contents of the patient controlled analgesia pump include 10 mg of morphine, 50 cc of 2.8% lidocaine, 8 mg of Ondansetron ampoule (4 cc), one gram of Apotel (6.7 cc) and the rest of normal saline to reach a total volume of 100 cc.</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>Hamed Beyzaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahinfar faculty of medicine, Imam Khomeini Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 51 3225 6291</telephone>
        <email>hmd_beyzaii@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Beyzaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 48. 6th baharestan st, Sadjad blv.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187147578</zip>
        <telephone>+98 51 3765 5378</telephone>
        <email>hmd_beyzaii@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are in American Society of Anesthesiologists(ASA) class 1 and 2
Patients who are between 45 and 75 years old
Patients with a Body Mass Index(BMI) in the range of 20-25
Patients who undergo spinal anesthesia for surgery</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of epilepsy
Patients with known kidney disease
Patients with heart block
Patients with drug addiction
Patients with medical histories that show sensitivity to lidocaine and opioid substances
Patients with coagulation disorders
Patients with skin infection at the injection site
Patients who had a history of moderate to severe nausea and vomiting in the last 24 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee, 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>Control group: Spinal anesthesia; 25-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 mg of Adrenaline was injected at either the third or fourth lumbar epidural space with median or paramedian approach. The content of the patient controlled analgesia pump attached to the patient included 20 mg of morphine, 8 mg of Ondansetron ampoule (4 cc), 1g of Apotel (6.7 cc) and the rest of normal saline to reach a total volume of 100 cc.</i_keyword>
      <i_keyword>Intervention group: Spinal anesthesia; 25-gauge spinal needle (Dr.J Tianjin Hanaco Medical Co. Tianjin, China) was introduced, then 0.5% Bupivacaine mixed with 0.2 mg of Adrenaline was injected at either the third or fourth lumbar epidural space with median or paramedian approach. The contents of the patient controlled analgesia pump include 10 mg of morphine, 50 cc of 2.8% lidocaine, 8 mg of Ondansetron ampoule (4 cc), one gram of Apotel (6.7 cc) and the rest of normal saline to reach a total volume of 100 cc.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postoperative pain. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Postoperative nausea and vomiting. Timepoint: 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Pulse oximetry.</prim_outcome>
      <prim_outcome>Systolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.</prim_outcome>
      <prim_outcome>Diastolic pressure. Timepoint: Immediately after the surgery and 4 hours after the surgery, 8 hours after the surgery, 24 hours after the surgery. Method of measurement: Dial sphygmomanometer.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-16</approval_date>
        <contact_name>Ethics committee of Islamic Azad University, Mashhad branch</contact_name>
        <contact_address>No. 8, Emam Khomeini Ave, Shahinfar Medical School Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
