xml: <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/NCT05997940</url>
    </required_header>
    <id_info>
      <org_study_id>2022/03</org_study_id>
      <nct_id>NCT05997940</nct_id>
    </id_info>
    <brief_title>Effectiveness Of The Pericapsular Nerve Group (PENG) Block In Hip Surgery</brief_title>
    <official_title>Evaluation Of The Postoperative Analgesic Effectiveness Of The Pericapsular Nerve Group Block Performed Before Spinal Anesthesia In Hip Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aydin Adnan Menderes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aydin Adnan Menderes 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>
        The target population of hip surgery is usually the elderly patients with systemic&#xD;
        comorbidity. Especially hip fractures are common in society and cause high morbidity and&#xD;
        mortality for geriatric patients . Pain felt before and during surgery can cause metabolic&#xD;
        and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia&#xD;
        and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce&#xD;
        postoperative complications and mortality and accelerate post-surgical recovery.&#xD;
        Pharmacological methods such as opioids and NSAIDs used for this may cause further&#xD;
        deterioration and other side effects in geriatric patients with reduced renal and hepatic&#xD;
        function, thus delaying post-surgical recovery and thus discharge. In order to avoid these&#xD;
        side effects, regional anesthesia techniques can be preferred.&#xD;
  &#xD;
        Regional anesthesia techniques are among the most effective methods of postoperative&#xD;
        analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods.&#xD;
        Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they&#xD;
        provide effective analgesia, reduce the need for opioids and consequently their side effects,&#xD;
        are effective in the treatment of dynamic pain and facilitate recovery.&#xD;
  &#xD;
        Patients undergoing hip surgery have very severe pain and need additional postoperative&#xD;
        analgesics. Mobilization of patients is delayed due to pain . Depending on this ,&#xD;
        thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis ,&#xD;
        wound infection and increased length of stay.&#xD;
  &#xD;
        Alleviating the pain around the hip joint capsule is an effective analgesia method in hip&#xD;
        surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator ,&#xD;
        and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these&#xD;
        nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24&#xD;
        hours postoperatively. PENG block is a method that is frequently used in the world and in our&#xD;
        clinic and has a low complication rate.&#xD;
  &#xD;
        In this study, the investigators aimed to show that pericapsular nerve group block performed&#xD;
        before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total&#xD;
        opioid consumption.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2023</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Preoperative</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>During the spinal anesthesia</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Postoperative 0. hour</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Postoperative 1. hour</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Postoperative 6. hour</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Postoperative 12. hour</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Numeric Rating Scale (NRS) for postoperative analgesic efficacy</measure>
      <time_frame>Postoperative 24. hour</time_frame>
      <description>NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amounts of postoperative analgesic consumption</measure>
      <time_frame>Postoperative 24 hours</time_frame>
      <description>Postoperative analgesic consumption amounts will be compared between the patients performed PENG block and the control group.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>PENG Block</condition>
    <arm_group>
      <arm_group_label>PENG</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PENG block performed before spinal anesthesia</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PENG block</intervention_name>
      <description>The PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) 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. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 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 was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL</description>
      <arm_group_label>PENG</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with written informed consent&#xD;
  &#xD;
            -  Patients over 18 years old&#xD;
  &#xD;
            -  Patients with ASA score I-II-III&#xD;
  &#xD;
            -  Patients performed spinal anesthesia for surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients without written informed consent&#xD;
  &#xD;
            -  Patients with ASA score IV and above&#xD;
  &#xD;
            -  Patients who cannot be communicated&#xD;
  &#xD;
            -  Patients with infection at the block site&#xD;
  &#xD;
            -  Patients with coagulation disorders&#xD;
  &#xD;
            -  Patients not suitable for spinal anesthesia&#xD;
  &#xD;
            -  Patients with liver and kidney failure&#xD;
  &#xD;
            -  Patients who are allergic to the drugs used&#xD;
  &#xD;
            -  Patients with major complications during the operation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kadir Berkay TAN, Resident Doctor</last_name>
      <phone>+905393506273</phone>
      <email>k.berkay.tan@adu.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mustafa OGURLU, Professor Doctor</last_name>
      <phone>+905326056932</phone>
      <email>mogurlu@adu.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Adnan Menderes University Faculty of Medicine</name>
        <address>
          <city>Aydın</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kadir Berkay TAN, Resident Doctor</last_name>
        <phone>+905393506273</phone>
        <email>k.berkay.tan@adu.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
      <investigator_full_name>Mustafa Ogurlu</investigator_full_name>
      <investigator_title>Professor Doctor</investigator_title>
    </responsible_party>
    <keyword>Pericapsular nerve group (PENG) block</keyword>
    <keyword>Postoperative analgesia</keyword>
    <keyword>Hip Surgery</keyword>
    <keyword>Regional anesthesia</keyword>
    <keyword>Spinal anesthesia</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997940
  org study id: 2022/03
  nct id: NCT05997940
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The target population of hip surgery is usually the elderly patients with systemic
        comorbidity. Especially hip fractures are common in society and cause high morbidity and
        mortality for geriatric patients . Pain felt before and during surgery can cause metabolic
        and endocrine changes in the body, leading to sleep disorders, depression, delirium, dementia
        and persistent chronic pain. With effective postoperative analgesia, it is possible to reduce
        postoperative complications and mortality and accelerate post-surgical recovery.
        Pharmacological methods such as opioids and NSAIDs used for this may cause further
        deterioration and other side effects in geriatric patients with reduced renal and hepatic
        function, thus delaying post-surgical recovery and thus discharge. In order to avoid these
        side effects, regional anesthesia techniques can be preferred.
  
        Regional anesthesia techniques are among the most effective methods of postoperative
        analgesia. Peripheral nerve blocks are also one of the regional anesthesia methods.
        Peripheral nerve blocks; They are the most ideal postoperative analgesia methods because they
        provide effective analgesia, reduce the need for opioids and consequently their side effects,
        are effective in the treatment of dynamic pain and facilitate recovery.
  
        Patients undergoing hip surgery have very severe pain and need additional postoperative
        analgesics. Mobilization of patients is delayed due to pain . Depending on this ,
        thromboembolism , deep vein The risk of nosocomial infection increases due to thrombosis ,
        wound infection and increased length of stay.
  
        Alleviating the pain around the hip joint capsule is an effective analgesia method in hip
        surgeries. The anterior capsule of the hip joint is innervated by the femoral , obturator ,
        and accessory obturator nerves . Pericapsular nerve group (PENG) block also targets these
        nerves. Many studies have shown that PENG block provides adequate analgesia for more than 24
        hours postoperatively. PENG block is a method that is frequently used in the world and in our
        clinic and has a low complication rate.
  
        In this study, the investigators aimed to show that pericapsular nerve group block performed
        before spinal anesthesia in hip surgeries reduces postoperative pain and decreases total
        opioid consumption.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Preoperative
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: During the spinal anesthesia
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Postoperative 0. hour
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Postoperative 1. hour
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Postoperative 6. hour
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Postoperative 12. hour
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Numeric Rating Scale (NRS) for postoperative analgesic efficacy
  time frame: Postoperative 24. hour
  description: NRS is a one-dimensional scale used to measure pain intensity. The patient is asked to select the number that best describes the level of pain as 0 = no pain and 10 = worst pain (unbearable).
  measure: Amounts of postoperative analgesic consumption
  time frame: Postoperative 24 hours
  description: Postoperative analgesic consumption amounts will be compared between the patients performed PENG block and the control group.
  arm group label: PENG
  arm group type: Active Comparator
  description: PENG block performed before spinal anesthesia
  arm group label: Control
  arm group type: No Intervention
  intervention type: Drug
  intervention name: PENG block
  description: The PENG block was performed with the patient in the supine position at preoperative waiting room. A curvilinear low-frequency ultrasound probe (2-5 MHz) 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. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22 gauge, 100 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 was injected in 5 mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL
  arm group label: PENG
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kadir Berkay TAN, Resident Doctor
  phone: +905393506273
  email: k.berkay.tan@adu.edu.tr
  last name: Mustafa OGURLU, Professor Doctor
  phone: +905326056932
  email: mogurlu@adu.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Aydin Adnan Menderes University
  investigator full name: Mustafa Ogurlu
  investigator title: Professor Doctor