<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/NCT03783247</url>
  </required_header>
  <id_info>
    <org_study_id>Swelam PENG block</org_study_id>
    <nct_id>NCT03783247</nct_id>
  </id_info>
  <brief_title>Peri-capsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty</brief_title>
  <official_title>Pericapsular Nerve Group Block Versus Fascia Iliaca Block for Hip Arthroplasty: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</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 this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG)&#xD;
      block in hip surgeries as a post-operative pain management technique in comparison with&#xD;
      fascia Iliaca block in hip surgeries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hip fracture is a common orthopedic emergency in the elderly, and it is associated with&#xD;
      significant morbidity and mortality.1 Surgical reduction and fixation are the definitive&#xD;
      treatment in most patients.2 Effective perioperative analgesia that minimizes the need for&#xD;
      opioids and related adverse effects (such as delirium) is essential in this patient&#xD;
      population.&#xD;
&#xD;
      Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB),&#xD;
      and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing&#xD;
      effects and reduction in opioid-related adverse effects. The effect size of analgesia from&#xD;
      these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not&#xD;
      covered.&#xD;
&#xD;
      The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as&#xD;
      reported by previous anatomic studies. The anterior capsule is the most richly innervated&#xD;
      section of the joint, suggesting these nerves should be the main targets for hip analgesia. A&#xD;
      recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by&#xD;
      these 3 main nerves but also found that the AON and FN play a greater role in the anterior&#xD;
      hip innervation than previously reported. This study also identified the relevant landmarks&#xD;
      for those articular branches. The high articular branches from FN and AON are consistently&#xD;
      found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE),&#xD;
      whereas the ON , close to the inferomedial acetabulum. Using this information, the&#xD;
      investigator developed an ultrasound-guided technique for blockade of these articular&#xD;
      branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the&#xD;
      investigator will examine the efficacy of PENG block in hip surgeries as a post-operative&#xD;
      pain management technique in comparison with fascia Iliaca block in hip surgeries&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2019</start_date>
  <completion_date type="Anticipated">June 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2019</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>randomized double-blinded</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperatively.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>morphine consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>total morphine consumption over 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain scale Visual analogue Scale</measure>
    <time_frame>24hours</time_frame>
    <description>Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>muscle power</measure>
    <time_frame>24 HOURS</time_frame>
    <description>Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Post Operative Pain Management</condition>
  <arm_group>
    <arm_group_label>FIB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>hip fracture with fascia Iliaca block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PENG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hip fracture with Pericapsular nerve group block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pericapsular nerve group block</intervention_name>
    <description>The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees (Figs. 2, 3). In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was 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. Following negative aspiration, the local anesthetic solution (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL</description>
    <arm_group_label>PENG</arm_group_label>
    <other_name>PENG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fascia Iliaca BLock</intervention_name>
    <description>In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest &amp; iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.</description>
    <arm_group_label>FIB</arm_group_label>
    <other_name>FIB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for hip replacement surgeries e.g. hip hemiarthroplasty, total hip&#xD;
             arthroplasty under subarachnoid block (SAB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  infection at the injection site&#xD;
&#xD;
          -  allergy to local anesthetics&#xD;
&#xD;
          -  severe cardiopulmonary disease (≥ASA IV)&#xD;
&#xD;
          -  diabetic or other neuropathies&#xD;
&#xD;
          -  patients receiving opioids for chronic analgesic therapy&#xD;
&#xD;
          -  contraindication to spinal anesthesia&#xD;
&#xD;
          -  inability to comprehend visual analog scale (VAS).&#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>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>1234</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hassan Mohamed Ali</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </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>Undecided</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/NCT03783247
org study id: Swelam PENG block
nct id: NCT03783247
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG)
      block in hip surgeries as a post-operative pain management technique in comparison with
      fascia Iliaca block in hip surgeries
Hip fracture is a common orthopedic emergency in the elderly, and it is associated with
      significant morbidity and mortality.1 Surgical reduction and fixation are the definitive
      treatment in most patients.2 Effective perioperative analgesia that minimizes the need for
      opioids and related adverse effects (such as delirium) is essential in this patient
      population.

      Regional analgesic techniques, including femoral nerve (FN) block, fascia iliaca block (FIB),
      and 3-in-1 FN block, are popular analgesic strategies, due mainly to their opioid-sparing
      effects and reduction in opioid-related adverse effects. The effect size of analgesia from
      these blocks is only moderate, and literature suggests that the obturator nerve (ON) is not
      covered.

      The anterior hip capsule is innervated by the ON, accessory obturator nerve (AON), and FN as
      reported by previous anatomic studies. The anterior capsule is the most richly innervated
      section of the joint, suggesting these nerves should be the main targets for hip analgesia. A
      recent anatomical study by Short et al15 confirmed the innervation of the anterior hip by
      these 3 main nerves but also found that the AON and FN play a greater role in the anterior
      hip innervation than previously reported. This study also identified the relevant landmarks
      for those articular branches. The high articular branches from FN and AON are consistently
      found between the anterior inferior iliac spines (AIIS) and the iliopubic eminence (IPE),
      whereas the ON , close to the inferomedial acetabulum. Using this information, the
      investigator developed an ultrasound-guided technique for blockade of these articular
      branches to the hip, the PENG (PEricapsular Nerve Group) block. In this study, the
      investigator will examine the efficacy of PENG block in hip surgeries as a post-operative
      pain management technique in comparison with fascia Iliaca block in hip surgeries
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized double-blinded
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperatively.
measure: morphine consumption
time frame: 24 hours
description: total morphine consumption over 24 hours
measure: pain scale Visual analogue Scale
time frame: 24hours
description: Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
measure: muscle power
time frame: 24 HOURS
description: Assessment of quadriceps femoris muscle strength: For motor block assessment, the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
arm group label: FIB
arm group type: Experimental
description: hip fracture with fascia Iliaca block
arm group label: PENG
arm group type: Experimental
description: Hip fracture with Pericapsular nerve group block
intervention type: Procedure
intervention name: Pericapsular nerve group block
description: The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees (Figs. 2, 3). In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was 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. Following negative aspiration, the local anesthetic solution (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL
arm group label: PENG
other name: PENG
intervention type: Procedure
intervention name: Fascia Iliaca BLock
description: In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
arm group label: FIB
other name: FIB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hassan Mohamed Ali
investigator title: associate professor
mesh term: Pain, Postoperative
sharing ipd: Undecided