<?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>IRCT20131108015322N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-25</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of combined sciatic –femoral nerve blocks and lateral femoral cutaneous nerve  on thigh tourniquet pain in foot and ankle orthopedic surgery"</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of combined sciatic –femoral nerve blocks together with lateral femoral cutaneous nerve  block on thigh tourniquet pain   with spinal anesthesia in foot and ankle orthopedic surgery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48297</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants are randomly assigned to 1 of 2  groups following simple randomization by using a random numbers table . The allocation sequence was concealed in sequentially numbered, opaque, sealed envelopes. After acceptance of the eligible patient and in the operating room, the numbered envelope is opened by an investigator with no clinical involvement in the trial. Randomization and assignment of patients is done by a person not involved in the study. The person who measures the outcome in two groups is also kept blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Treatment of thigh tourniquet- related acute pain during lower limb surgery.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In the patients in the control group, the standard method of spinal anesthesia is performed in the lateral position. 3 ml of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle. Then the patients are placed in the supine position. Intervention 2: Intervention group:In this group, blockade of popliteal, femoral nerve (FN), and lateral femoral cutaneous nerve (LFCN) block are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer and a 22G-bevel 30°, 85 mm block needle (Visioplex®, Vygon, Ecouen, France). In the lateral position, 20 ml of 1.5% lidocaine with epinephrine 1:200000 + bicarbonate is administered for popliteal block . 15 ml and 5 ml of the same solution is injected for block of the FN and LFCN, respectively in the supine position.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shideh dabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2595</telephone>
        <email>shdabir@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shideh Dabir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology and Critical care Department, Taleghani Hospital, Arabi St., Yemen St., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717413</zip>
        <telephone>+98 21 2243 2595</telephone>
        <email>shdabir@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>ASA class I,II
Age 18-70 years
Unilateral foot and ankle orthopedic surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>ASA class≥ III
Allergy to local anesthetics
Coagulation disorders
opium addiction
Uncooperative patient
Infection at nerve block site
Vascular grafting of femoral or popliteal vessels
BMI≥30
Sickle cell anemia
Extensive and traumatic surgery of tibia and fibula
Tourniquet inflation time less than 60 minutes
Patient refusal</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>Control group: In the patients in the control group, the standard method of spinal anesthesia is performed in the lateral position. 3 ml of 0.5% hyperbaric bupivacaine is injected intrathecally using a 25G Quincke spinal needle. Then the patients are placed in the supine position.</i_keyword>
      <i_keyword>Intervention group:In this group, blockade of popliteal, femoral nerve (FN), and lateral femoral cutaneous nerve (LFCN) block are performed under the guidance of ultrasound (SonoSite S-Nerve, Bothell, WA, USA) using a 6-13 MHz linear transducer and a 22G-bevel 30°, 85 mm block needle (Visioplex®, Vygon, Ecouen, France). In the lateral position, 20 ml of 1.5% lidocaine with epinephrine 1:200000 + bicarbonate is administered for popliteal block . 15 ml and 5 ml of the same solution is injected for block of the FN and LFCN, respectively in the supine position.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intraoperative severity of tourniquet pain. Timepoint: Immediately after tourniquet inflation, and then every 5 min until the end of surgery. Method of measurement: Tourniquet pain intensity is evaluated by using a 5-point verbal rating scale (VRS) (0 =no pain, 1= mild pain, 2=moderate pain, 3= severe pain, 4=unbearable pain).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time taken to perform the block. Timepoint: The time taken from the beginning to the end of local anesthetic injection. Method of measurement: The interval ( minutes) between the beginning to the end of local anesthetic injection.</sec_outcome>
      <sec_outcome>Anesthetic effect time. Timepoint: Time required from the end of local anesthetic injection to achieve adequate anesthesia. Method of measurement: The interval (minutes) between the end of local anesthetic injection and block success required for surgical anesthesia.</sec_outcome>
      <sec_outcome>Intraoperative total doses of fentanyl and ketamin. Timepoint: During operation. Method of measurement: Boluses of intravenous fentanyl (µg) or ketamine (mg) given during surgery are recorded and for each drug, the total dose was calculated.</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>2019-04-30</approval_date>
        <contact_name>Research Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Building No. 2, 6th floor, Office of Research Affairs, Shahid Chamran Highway, Yemen St., Arabi St., next to Taleghani Hospital Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
