<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/NCT04426045</url>
  </required_header>
  <id_info>
    <org_study_id>4-2020-0417</org_study_id>
    <nct_id>NCT04426045</nct_id>
  </id_info>
  <brief_title>Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial</brief_title>
  <official_title>Pericapsular Nerve Group (PENG) Block Versus Supra-inguinal Fascia Iliaca Compartment Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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>
      Adequate pain control after total hip arthroplasty is crucial for early ambulation and&#xD;
      patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described&#xD;
      as a promising technique for primary total hip arthroplasty. However, one of the concerns&#xD;
      with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps&#xD;
      weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been&#xD;
      recently introduced a new technique for blockade of the articular branches of the femoral,&#xD;
      obturator and accessory obturator nerves. PENG block is possible to provide sufficient&#xD;
      analgesia and preserve lower limb muscle strength. The investigators will compare&#xD;
      ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients&#xD;
      undergoing total hip arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">June 6, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric rating scale pain score</measure>
    <time_frame>1 hour after the surgery</time_frame>
    <description>Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric rating scale pain score</measure>
    <time_frame>6 hours after the surgery</time_frame>
    <description>Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric rating scale pain score</measure>
    <time_frame>24 hours after the surgery</time_frame>
    <description>Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric rating scale pain score</measure>
    <time_frame>36 hours after the surgery</time_frame>
    <description>Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numeric rating scale pain score</measure>
    <time_frame>48 hours after the surgery</time_frame>
    <description>Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quadriceps muscle strength</measure>
    <time_frame>baseline</time_frame>
    <description>Quadriceps muscle strength will be measured by the dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps muscle strength</measure>
    <time_frame>at 6 hours postoperatively</time_frame>
    <description>Quadriceps muscle strength will be measured by the dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps muscle strength</measure>
    <time_frame>at 24 hours postoperatively</time_frame>
    <description>Quadriceps muscle strength will be measured by the dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadriceps muscle strength</measure>
    <time_frame>at 36 hours postoperatively</time_frame>
    <description>Quadriceps muscle strength will be measured by the dynamometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receiving pericapsular nerve group block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supra-inguinal fascia iliaca compartment block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receiving supra-inguinal fascia iliaca compartment block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pericapsular nerve group block</intervention_name>
    <description>A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.2% will be injected.</description>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
    <other_name>PENG block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Supra-inguinal fascia iliaca compartment block</intervention_name>
    <description>A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the &quot;bow-tie sign&quot; formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected.</description>
    <arm_group_label>Supra-inguinal fascia iliaca compartment block</arm_group_label>
    <other_name>Supra-inguinal FICB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 19 years old or older, with American Society of Anesthesiologists&#xD;
             Physical Status 1-3&#xD;
&#xD;
          -  scheduled for elective unilateral total hip arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or intolerance to any of the drugs used in the study&#xD;
&#xD;
          -  Hepatic or renal insufficiency&#xD;
&#xD;
          -  Opioid dependency&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pre-existing neurologic or anatomic deficits in the lower extremities&#xD;
&#xD;
          -  Severe psychiatric illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anesthesia and Pain Research Institute, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04426045
org study id: 4-2020-0417
nct id: NCT04426045
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adequate pain control after total hip arthroplasty is crucial for early ambulation and
      patient satisfaction. The supra-inguinal fascia iliaca compartment block has been described
      as a promising technique for primary total hip arthroplasty. However, one of the concerns
      with supra-inguinal fascia iliaca compartment block is still the potential for quadriceps
      weakness that might delay ambulation. The pericapsular nerve group (PENG) block has been
      recently introduced a new technique for blockade of the articular branches of the femoral,
      obturator and accessory obturator nerves. PENG block is possible to provide sufficient
      analgesia and preserve lower limb muscle strength. The investigators will compare
      ultrasound-guided supra-inguinal fascia iliaca compartment block with PENG block in patients
      undergoing total hip arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Numeric rating scale pain score
time frame: 1 hour after the surgery
description: Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
measure: Numeric rating scale pain score
time frame: 6 hours after the surgery
description: Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
measure: Numeric rating scale pain score
time frame: 24 hours after the surgery
description: Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
measure: Numeric rating scale pain score
time frame: 36 hours after the surgery
description: Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
measure: Numeric rating scale pain score
time frame: 48 hours after the surgery
description: Pain intensity at rest and during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain)
measure: Quadriceps muscle strength
time frame: baseline
description: Quadriceps muscle strength will be measured by the dynamometer
measure: Quadriceps muscle strength
time frame: at 6 hours postoperatively
description: Quadriceps muscle strength will be measured by the dynamometer
measure: Quadriceps muscle strength
time frame: at 24 hours postoperatively
description: Quadriceps muscle strength will be measured by the dynamometer
measure: Quadriceps muscle strength
time frame: at 36 hours postoperatively
description: Quadriceps muscle strength will be measured by the dynamometer
arm group label: Pericapsular nerve group block
arm group type: Experimental
description: Participants receiving pericapsular nerve group block
arm group label: Supra-inguinal fascia iliaca compartment block
arm group type: Active Comparator
description: Participants receiving supra-inguinal fascia iliaca compartment block
intervention type: Procedure
intervention name: Pericapsular nerve group block
description: A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.2% will be injected.
arm group label: Pericapsular nerve group block
other name: PENG block
intervention type: Procedure
intervention name: Supra-inguinal fascia iliaca compartment block
description: A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the "bow-tie sign" formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected.
arm group label: Supra-inguinal fascia iliaca compartment block
other name: Supra-inguinal FICB
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No