<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04402450</url>
  </required_header>
  <id_info>
    <org_study_id>OAIC 1111/20</org_study_id>
    <nct_id>NCT04402450</nct_id>
  </id_info>
  <brief_title>Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia</brief_title>
  <official_title>A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic&#xD;
      option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed&#xD;
      pericapsular nerve group block or PENG block, that selectively targets the articular branches&#xD;
      of the femoral and obturator nerves while sparing their motor components. In this randomized&#xD;
      trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing&#xD;
      primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was&#xD;
      selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the&#xD;
      hypothesis that PENG block will result in significantly less motor block compared to SFIB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective randomized comparison between two analgesic techniques</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of quadriceps motor block (defined as paralysis or paresis).</measure>
    <time_frame>6 hours after block performance</time_frame>
    <description>Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Block performance time</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>temporal interval between the start of skin disinfection and the end of LA injection through the block needle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>3 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>6 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>12 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>18 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>24 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>36 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Static and dynamic pain</measure>
    <time_frame>48 hours after the block</time_frame>
    <description>Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative morphine consumption</measure>
    <time_frame>24 hours after the block</time_frame>
    <description>consumption of intravenous morphine registered by a patient controlled analgesia device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative morphine consumption</measure>
    <time_frame>48 hours after the block</time_frame>
    <description>consumption of intravenous morphine registered by a patient controlled analgesia device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block</measure>
    <time_frame>3 hours after the block</time_frame>
    <description>Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block</measure>
    <time_frame>6 hours after the block</time_frame>
    <description>Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block</measure>
    <time_frame>24 hours after the block</time_frame>
    <description>Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of quadriceps motor block (defined as paralysis or paresis).</measure>
    <time_frame>3 hours after the block</time_frame>
    <description>Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of quadriceps motor block (defined as paralysis or paresis).</measure>
    <time_frame>24 hours after the block</time_frame>
    <description>Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip adduction strength.</measure>
    <time_frame>3 hours after the block</time_frame>
    <description>Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip adduction strength.</measure>
    <time_frame>6 hours after the block</time_frame>
    <description>Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip adduction strength.</measure>
    <time_frame>24 hours after the block</time_frame>
    <description>Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block-related complications</measure>
    <time_frame>1 hour after the block</time_frame>
    <description>vascular puncture, paresthesia or systemic local anesthetic toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative opioid related side effects</measure>
    <time_frame>48 hours after the block</time_frame>
    <description>Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inability to perform physiotherapy due to motor block</measure>
    <time_frame>Postoperative day 1</time_frame>
    <description>Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inability to perform physiotherapy due to motor block</measure>
    <time_frame>postoperative day 2</time_frame>
    <description>Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inability to perform physiotherapy due to pain</measure>
    <time_frame>postoperative day 1</time_frame>
    <description>Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inability to perform physiotherapy due to pain</measure>
    <time_frame>postoperative day 2</time_frame>
    <description>Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Postoperative Pain</condition>
  <condition>Weakness, Muscle</condition>
  <condition>Motor Activity</condition>
  <arm_group>
    <arm_group_label>suprainguinal fascia iliaca block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided suprainguinal fascia iliaca nerve block</intervention_name>
    <description>After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.</description>
    <arm_group_label>suprainguinal fascia iliaca block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided pericapsular nerves group of the hip block</intervention_name>
    <description>After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.</description>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 80 years&#xD;
&#xD;
          -  American Society of Anesthesiologists classification 1-3&#xD;
&#xD;
          -  Body mass index between 20 and 35 (kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults who are unable to give their own consent&#xD;
&#xD;
          -  Pre-existing neuropathy (assessed by history and physical examination)&#xD;
&#xD;
          -  Coagulopathy (assessed by history and physical examination and, if deemed clinically&#xD;
             necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4&#xD;
             or prothrombin time ≥ 50)&#xD;
&#xD;
          -  Renal failure (assessed by history and physical examination and, if deemed clinically&#xD;
             necessary, by blood work up i.e. creatinine ≥ 100)&#xD;
&#xD;
          -  Hepatic failure (assessed by history and physical examination and, if deemed&#xD;
             clinically necessary, by blood work up i.e. transaminases ≥ 100)&#xD;
&#xD;
          -  Allergy to local anesthetics (LAs)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prior surgery in the corresponding side of the inguinal or suprainguinal area&#xD;
&#xD;
          -  Chronic pain syndromes requiring opioid intake at home&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clínico Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitan</state>
        <zip>8380456</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <results_reference>
    <citation>Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.</citation>
    <PMID>30063657</PMID>
  </results_reference>
  <results_reference>
    <citation>Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.</citation>
    <PMID>21401544</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>September 26, 2021</last_update_submitted>
  <last_update_submitted_qc>September 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Julian Aliste</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>unidentified data can be shared upon reasonable request after study publication</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402450
org study id: OAIC 1111/20
nct id: NCT04402450
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic
      option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed
      pericapsular nerve group block or PENG block, that selectively targets the articular branches
      of the femoral and obturator nerves while sparing their motor components. In this randomized
      trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing
      primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was
      selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the
      hypothesis that PENG block will result in significantly less motor block compared to SFIB.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective randomized comparison between two analgesic techniques
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
time frame: 6 hours after block performance
description: Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
measure: Block performance time
time frame: 1 hour after surgery
description: temporal interval between the start of skin disinfection and the end of LA injection through the block needle
measure: Static and dynamic pain
time frame: 3 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 6 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 12 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 18 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 24 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 36 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Static and dynamic pain
time frame: 48 hours after the block
description: Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
measure: Postoperative morphine consumption
time frame: 24 hours after the block
description: consumption of intravenous morphine registered by a patient controlled analgesia device
measure: Postoperative morphine consumption
time frame: 48 hours after the block
description: consumption of intravenous morphine registered by a patient controlled analgesia device
measure: Sensory block
time frame: 3 hours after the block
description: Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
measure: Sensory block
time frame: 6 hours after the block
description: Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
measure: Sensory block
time frame: 24 hours after the block
description: Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
time frame: 3 hours after the block
description: Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
measure: Presence of quadriceps motor block (defined as paralysis or paresis).
time frame: 24 hours after the block
description: Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
measure: Hip adduction strength.
time frame: 3 hours after the block
description: Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
measure: Hip adduction strength.
time frame: 6 hours after the block
description: Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
measure: Hip adduction strength.
time frame: 24 hours after the block
description: Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
measure: Block-related complications
time frame: 1 hour after the block
description: vascular puncture, paresthesia or systemic local anesthetic toxicity
measure: Postoperative opioid related side effects
time frame: 48 hours after the block
description: Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
measure: Inability to perform physiotherapy due to motor block
time frame: Postoperative day 1
description: Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.
measure: Inability to perform physiotherapy due to motor block
time frame: postoperative day 2
description: Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.
measure: Inability to perform physiotherapy due to pain
time frame: postoperative day 1
description: Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.
measure: Inability to perform physiotherapy due to pain
time frame: postoperative day 2
description: Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.
arm group label: suprainguinal fascia iliaca block
arm group type: Active Comparator
description: Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
arm group label: Pericapsular nerve group block
arm group type: Experimental
description: Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle.
intervention type: Procedure
intervention name: Ultrasound-guided suprainguinal fascia iliaca nerve block
description: After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.
arm group label: suprainguinal fascia iliaca block
intervention type: Procedure
intervention name: Ultrasound-guided pericapsular nerves group of the hip block
description: After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.
arm group label: Pericapsular nerve group block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Chile
citation: Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PMID: 30063657
citation: Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
PMID: 21401544
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Julian Aliste
investigator title: Assistant Professor
mesh term: Muscle Weakness
mesh term: Postoperative Complications
sharing ipd: No
ipd description: unidentified data can be shared upon reasonable request after study publication