<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/NCT04423419</url>
  </required_header>
  <id_info>
    <org_study_id>postoperative pain</org_study_id>
    <nct_id>NCT04423419</nct_id>
  </id_info>
  <brief_title>Peri-articular Nerve Group Block Versus Fascia Iliaca Block on Postoperative Pain After Hip Arthroscopy</brief_title>
  <official_title>the Efficacy of Peri-articular Nerve Group Block(PENG Block)Versus Fascia Iliaca Block on Immediate Post Operative Pain and Opioid Consumption After Hip Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia&#xD;
      iliaca block in reducing post operative pain within the first 24 hours following hip&#xD;
      arthroscopy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent decades hip arthroscopy gained popularity and the number of procedures increase&#xD;
      every year , due to the widening range of indications, as femoroacetabular impingement,&#xD;
      labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after&#xD;
      hip arthroscopy due to several factors. divided in two regions. First the intra-articular&#xD;
      where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony&#xD;
      resection. Outside the joint caused by traction, the portal tracts and extravasation of&#xD;
      irrigation , soft tissue swelling.&#xD;
&#xD;
      the hip joint found to be innervated from the femoral nerve for its anterior part, the&#xD;
      obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the&#xD;
      nerve to the quadratus femoris muscle for its postero-medial par&#xD;
&#xD;
      Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory&#xD;
      obturator and femoral nerve Also, it could spread to block the obturator nerve and its&#xD;
      articular branches the high articular branches from FN and AON are found between the anterior&#xD;
      inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close&#xD;
      to the inferomedial acetabulum.&#xD;
&#xD;
      The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface&#xD;
      of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with&#xD;
      the space between quadratus lumborum muscle and its fascia . Three important nerves for hip&#xD;
      innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral&#xD;
      cutaneous nerve&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2022</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>group A will undergo PENG block group B will undergo fascia iliaca block groupC will receive iv analgesia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>the patient and the assessor will mask about type of block</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy</measure>
    <time_frame>24 hours</time_frame>
    <description>by question the patient about pain and its degree using visual analogue pain score( VAS score),it takes score from (0-10) according to severity of pain ,higher score indicates greater pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of the analgesic effect of the block</measure>
    <time_frame>24 hours</time_frame>
    <description>evaluate duration of the analgesic effect of the block by calculating The time passed from block to the patient first analgesia request and total cumulative doses of analgesia</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>will undergo Peri -articular nerve group block for hip joint under ultrasound guide as analgesia post operative after hip arthroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>will undergo ultrasound guided fascia iliaca block as postoperative analgesia after hip arthroscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>will receive ordinary IV analgesia during operation hip arthroscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PENG block</intervention_name>
    <description>The US probe placed in a transverse plane over the AIIS . 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 to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25%</description>
    <arm_group_label>A</arm_group_label>
    <other_name>injection of local anasthetics drug in peri-articular nerves of hip joint</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>fascia iliaca block</intervention_name>
    <description>ultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25%</description>
    <arm_group_label>B</arm_group_label>
    <other_name>injection of local anathetics drug in fascia ilica space</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IV analgesia</intervention_name>
    <description>IV analgesia</description>
    <arm_group_label>C</arm_group_label>
    <other_name>no block</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        age 16-60 years old ASA physical status I or II scheduled for hip arthroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  neurological deficits or neuropathy&#xD;
&#xD;
          -  opioid addict&#xD;
&#xD;
          -  local skin infections, bleeding diathesis, and coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>essam sharkawy, lecturer</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>safaa noaman, resident</last_name>
    <phone>201030333468</phone>
    <email>safa2gmsy@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mahmoud kamel, lecturer</last_name>
    <phone>201006464560</phone>
    <email>Mahmoudkamel2015@aun.edu.eg</email>
  </overall_contact_backup>
  <reference>
    <citation>1_ Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am 2012; 94: e23. 2_ Tan CO, Chong YM, Tran P et al. Surgical predictors of acute postoperative pain after hip arthroscopy. BMC Anesthesiol 2015; 15:96. 3- Jerry G. Xing,*yMD, MSc, FRCSC, Faraj W. Abdallah,zMD, Richard Brull,§MD, FRCPC,Stephanie Oldfield,§Andrew Dold,yMD, M. Lucas Murnaghan,||MD, MEd, FRCSC,and Daniel B. Whelan,{MD, FRCSC Preoperative Femoral Nerve Block for Hip Arthroscopy Randomized, Triple-Masked Controlled Trial The American Journal of Sports Medicine 2015 4_, Gardner E. The innervation of the hip joint. Anat Rec. 1948;101:353-371. 5_ Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular nerve group (PENG) block for hip fracture. RegAnesth Pain Med. 2018; 43(8):859-63. 6_ Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency procedures to relieve chronic hip pain. An evidence-based narrative review. Reg Anesth Pain Med. 2018;43:72-83. 7_S.M.White,R.Griffiths,J.Holloway,andA.Shannon,&quot;AnaesthesiaforproximalfemoralfractureintheUK:firstreportfrom theNHShipfractureanaesthesianetwork,&quot;Anaesthesia,vol.65, no.3,pp.243-248,2010.</citation>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 6, 2020</last_update_submitted>
  <last_update_submitted_qc>June 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Safa Sayed Noaman</investigator_full_name>
    <investigator_title>resident doctor</investigator_title>
  </responsible_party>
  <keyword>post operative pain</keyword>
  <keyword>hip arthroscopy</keyword>
  <!-- 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/NCT04423419
org study id: postoperative pain
nct id: NCT04423419
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to evaluate the efficacy of pericapsular nerve group block versus fascia
      iliaca block in reducing post operative pain within the first 24 hours following hip
      arthroscopy
In recent decades hip arthroscopy gained popularity and the number of procedures increase
      every year , due to the widening range of indications, as femoroacetabular impingement,
      labral tears, chondral injuries, loose bodies, osteonecrosis and septic arthritis Pain after
      hip arthroscopy due to several factors. divided in two regions. First the intra-articular
      where pain originates from the joint capsule (capsulotomy), a repaired labrum or bony
      resection. Outside the joint caused by traction, the portal tracts and extravasation of
      irrigation , soft tissue swelling.

      the hip joint found to be innervated from the femoral nerve for its anterior part, the
      obturator nerve for its antero-medial part, the sciatic nerve for its posterior part, and the
      nerve to the quadratus femoris muscle for its postero-medial par

      Pericapsular Nerve Group (PENG) Block aims to block the articular branches of the accessory
      obturator and femoral nerve Also, it could spread to block the obturator nerve and its
      articular branches the high articular branches from FN and AON are found between the anterior
      inferior iliac spine(AIIS) and the ilio pubic eminence (IPE), whereas the ON is located close
      to the inferomedial acetabulum.

      The fascia iliaca compartment is a virtual space anteriorly limited by the posterior surface
      of the fascia iliaca, posteriorly by the iliacus muscle and is cranially in continuation with
      the space between quadratus lumborum muscle and its fascia . Three important nerves for hip
      innervation are located in this space, the femoral nerve, obturator nerve and lateral femoral
      cutaneous nerve
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: group A will undergo PENG block group B will undergo fascia iliaca block groupC will receive iv analgesia
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: the patient and the assessor will mask about type of block
measure: evaluate the efficacy of pericapsular nerve group block versus fascia iliaca block in reducing post operative pain within the first 24 hours following hip arthroscopy
time frame: 24 hours
description: by question the patient about pain and its degree using visual analogue pain score( VAS score),it takes score from (0-10) according to severity of pain ,higher score indicates greater pain intensity.
measure: duration of the analgesic effect of the block
time frame: 24 hours
description: evaluate duration of the analgesic effect of the block by calculating The time passed from block to the patient first analgesia request and total cumulative doses of analgesia
arm group label: A
arm group type: Other
description: will undergo Peri -articular nerve group block for hip joint under ultrasound guide as analgesia post operative after hip arthroscopy
arm group label: B
arm group type: Other
description: will undergo ultrasound guided fascia iliaca block as postoperative analgesia after hip arthroscopy
arm group label: C
arm group type: Other
description: will receive ordinary IV analgesia during operation hip arthroscopy
intervention type: Procedure
intervention name: PENG block
description: The US probe placed in a transverse plane over the AIIS . 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 to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25%
arm group label: A
other name: injection of local anasthetics drug in peri-articular nerves of hip joint
intervention type: Procedure
intervention name: fascia iliaca block
description: ultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25%
arm group label: B
other name: injection of local anathetics drug in fascia ilica space
intervention type: Other
intervention name: IV analgesia
description: IV analgesia
arm group label: C
other name: no block
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: essam sharkawy, lecturer
role: Study Director
affiliation: Assiut University
last name: safaa noaman, resident
phone: 201030333468
email: safa2gmsy@gmail.com
last name: mahmoud kamel, lecturer
phone: 201006464560
email: Mahmoudkamel2015@aun.edu.eg
citation: 1_ Colvin AC, Harrast J, Harner C. Trends in hip arthroscopy. J Bone Joint Surg Am 2012; 94: e23. 2_ Tan CO, Chong YM, Tran P et al. Surgical predictors of acute postoperative pain after hip arthroscopy. BMC Anesthesiol 2015; 15:96. 3- Jerry G. Xing,*yMD, MSc, FRCSC, Faraj W. Abdallah,zMD, Richard Brull,§MD, FRCPC,Stephanie Oldfield,§Andrew Dold,yMD, M. Lucas Murnaghan,||MD, MEd, FRCSC,and Daniel B. Whelan,{MD, FRCSC Preoperative Femoral Nerve Block for Hip Arthroscopy Randomized, Triple-Masked Controlled Trial The American Journal of Sports Medicine 2015 4_, Gardner E. The innervation of the hip joint. Anat Rec. 1948;101:353-371. 5_ Girón-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular nerve group (PENG) block for hip fracture. RegAnesth Pain Med. 2018; 43(8):859-63. 6_ Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency procedures to relieve chronic hip pain. An evidence-based narrative review. Reg Anesth Pain Med. 2018;43:72-83. 7_S.M.White,R.Griffiths,J.Holloway,andA.Shannon,"AnaesthesiaforproximalfemoralfractureintheUK:firstreportfrom theNHShipfractureanaesthesianetwork,"Anaesthesia,vol.65, no.3,pp.243-248,2010.
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Safa Sayed Noaman
investigator title: resident doctor