<?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>IRCT20181128041783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of Obturator nerve block and Femoral nerve block with spinal anesthesia for analgesia after elective  knee arthroscopy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of Obturator nerve block and Femoral nerve block with spinal anesthesia for analgesia after elective  knee arthroscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35723</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Software, Blinding description: This is a double-blind interventional study (a study is one in which neither the nurse who is in charge of measuring the NRS nor the statistisian know about used analgesia method), all patients in Imam Reza hospital that are candidates for knee arthroscopy can be enrolled in this study after signing the contest form.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Comparison of obturator nerve block and femoral nerve block with spinal anesthesia in analgesia after elective knee arthroscopy.</hc_freetext>
      <i_freetext>Intervention 1: 1 Intervention group: For the obturator nerve block, the patient's hip should be placed in the abduction and the external rotational position. The ultrasound probe will be placed in the medial segment of the inguinal groove. After detecting the pectinose muscle, the probe head spins 40 to 50 degrees towards the cranial to reveal the hyperecho structure in the posterolateral pectinose (the lower edge of the upper rhomus pubis).Then, in the fascia space between the two muscles of Abductor Longus and the Abductor Brevis anterior branches, and between the abductor brevis and Abdactor magnus, the posterior branch of the obturator nerve is characterized by ultrasound and a stimulator of the nerve with a 0.5mA  and proper stimulation of the contraction of the abductor muscles. Linear probe with a frequency of 10 MHz is used for this purpose and the block is performed out of plane. In the vicinity of each anterior and posterior branches of the obturator nerve 5 cc lidocaine 2% with 0.5 cc bicarbonate and 25 micrograms of fentanyl and then 3 cc marcaine 0.5% with epinephrine 1/200000 is injected to increase block length. For the femoral block, after the preparation of the probe area, ultrasound is placed in the ligament of the inguinal lining. The lateral to the femoral artery and the sub facia Iliaka, the femoral nerve is targeted with the help of a nerve stimulus needle and in-plane ultrasound guidance. After a 0.5 mA  quadriceps shrinkage, 10 cc lidocaine 2% with 1 cc bicarbonate and 50 micrograms fentanyl and then 6 cc marcaine 0.5% with epinephrine 1/200000 are injected to increase the block length. Intervention 2: 2 Intervention group: To perform the spinal anesthesia, the patient is placed in setting position. In L4-L5 space, in the midline, with needle number 25, the needle is perpendicular to the Dora axis, after inserting the needle into the subarachnoid space, the needle is 90 degrees Rotate counterclockwise and inject 15 mg of marcaine 0.5% with 25 μg of fentanyl. After the anesthesia, the surface of the block is checked with a pinprick test to ensure that the level of the block reaches l3, which is a suitable level for performing orthoscopy.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mokarram Dori Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza hospital, Ebne sina Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913316</zip>
        <telephone>+98 38022713</telephone>
        <email>mokarramdm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mokarram Dori Mehrdad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza hospital, Ebme sina Ave</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913316</zip>
        <telephone>+98 51 3802 2713</telephone>
        <email>mokarramdm@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 18 to 50 years
Classification of American Society of Anesthesiology (ASA-1)
Non-sensitivity to local anesthetic drugs
BMI less than 30
patient satisfaction.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having coagulation disorders
Infection in the injection site
Having nerve disorders at the foot of the site</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>1 Intervention group: For the obturator nerve block, the patient's hip should be placed in the abduction and the external rotational position. The ultrasound probe will be placed in the medial segment of the inguinal groove. After detecting the pectinose muscle, the probe head spins 40 to 50 degrees towards the cranial to reveal the hyperecho structure in the posterolateral pectinose (the lower edge of the upper rhomus pubis).Then, in the fascia space between the two muscles of Abductor Longus and the Abductor Brevis anterior branches, and between the abductor brevis and Abdactor magnus, the posterior branch of the obturator nerve is characterized by ultrasound and a stimulator of the nerve with a 0.5mA  and proper stimulation of the contraction of the abductor muscles. Linear probe with a frequency of 10 MHz is used for this purpose and the block is performed out of plane. In the vicinity of each anterior and posterior branches of the obturator nerve 5 cc lidocaine 2% with 0.5 cc bicarbonate and 25 micrograms of fentanyl and then 3 cc marcaine 0.5% with epinephrine 1/200000 is injected to increase block length. For the femoral block, after the preparation of the probe area, ultrasound is placed in the ligament of the inguinal lining. The lateral to the femoral artery and the sub facia Iliaka, the femoral nerve is targeted with the help of a nerve stimulus needle and in-plane ultrasound guidance. After a 0.5 mA  quadriceps shrinkage, 10 cc lidocaine 2% with 1 cc bicarbonate and 50 micrograms fentanyl and then 6 cc marcaine 0.5% with epinephrine 1/200000 are injected to increase the block length.</i_keyword>
      <i_keyword>2 Intervention group: To perform the spinal anesthesia, the patient is placed in setting position. In L4-L5 space, in the midline, with needle number 25, the needle is perpendicular to the Dora axis, after inserting the needle into the subarachnoid space, the needle is 90 degrees Rotate counterclockwise and inject 15 mg of marcaine 0.5% with 25 μg of fentanyl. After the anesthesia, the surface of the block is checked with a pinprick test to ensure that the level of the block reaches l3, which is a suitable level for performing orthoscopy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of pain after surgery. Timepoint: The severity of pain in the recovery at 3, 6, 12 and 24 hours after surgery. Method of measurement: Numeric pain rating scale.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-15</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>No170, 36th Jalal Al-e-Ahmad Blv, Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
