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/NCT05965895</url>
    </required_header>
    <id_info>
      <org_study_id>FMBSUREC/09072023/Fakhry</org_study_id>
      <nct_id>NCT05965895</nct_id>
    </id_info>
    <brief_title>Ultrasound-Guided Continuous Serratus Anterior Plane Block vs Dexmedetomidine Infusion in Patients With Rib Fractures.</brief_title>
    <official_title>Ultrasound-Guided Continuous Serratus Anterior Plane Block Versus Intravenous Dexmedetomidine Infusion for Pain Control in Patients With Multiple Rib Fractures: A Prospective Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef 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 aim of this work is to compare analgesic efficacy in patients with multiple rib fractures&#xD;
        who will be managed with Ultrasound-guided continuous serratus anterior plane block versus&#xD;
        patients who will be managed with dexmedetomidine infusion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is&#xD;
        impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest&#xD;
        infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost&#xD;
        of treatment.Hence, aggressive pain management is a vital component of rib fracture&#xD;
        management for the healing of rib fractures, improvement of pulmonary functions, and&#xD;
        pulmonary rehabilitation.&#xD;
  &#xD;
        The number of rib fractures &gt;3, rib fracture locations, bilateral rib fractures,&#xD;
        intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the&#xD;
        mortality rates.&#xD;
  &#xD;
        The involvement of acute pain services in Multiple rib fractures (MRFs) is based on &quot;Rib&#xD;
        Fracture score&quot;. Rib fracture score = (breaks × sides) + age factor. &quot;Breaks&quot; is the total&#xD;
        number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral&#xD;
        fractures. Age is factored into the equation due to an increased risk of complications (age&#xD;
        factor = 0 if &lt;50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80&#xD;
        years). A score &gt;7, requires the involvement of acute pain team.&#xD;
  &#xD;
        There is a wide variety of strategies for treating acute pain , including multimodal opioid&#xD;
        and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia&#xD;
        (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use&#xD;
        of novel fascial plane blocks.&#xD;
  &#xD;
        Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided&#xD;
        interfascial plane block which has been used in managing pain due to MRFs. It is a relatively&#xD;
        recent technique, first described in 2013, that provides almost complete analgesia for the&#xD;
        thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two&#xD;
        planes were described, one superficial to serratus anterior muscle and second underneath the&#xD;
        muscle and above the rib. It is a safe, simple to perform block with no significant&#xD;
        contraindications or side effects. It can be performed in patients lying supine, rendering it&#xD;
        particularly useful in polytrauma patients who are unable to sit up or turn lateral for&#xD;
        regional blocks on the back. It can be safely given to polytrauma patients who may be having&#xD;
        hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a&#xD;
        theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial&#xD;
        plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it&#xD;
        would be a remote possibility as the injection is far from the pleura between two muscles or&#xD;
        above the rib.&#xD;
  &#xD;
        Use of continuous techniques using catheters has the benefit of providing prolonged analgesia&#xD;
        titrated to patient response.&#xD;
  &#xD;
        Dexmedetomidine is a highly selective α-2 adrenoceptor agonist. It has sympatholytic,&#xD;
        sedative, amnestic, and analgesic properties. It provides a unique analgesia, without&#xD;
        respiratory depression best described as opioid- sparing. The analgesic properties of α-2&#xD;
        agonists are mediated by Supraspinal (locus ceruleus) and spinal (dorsal horn) mechanisms.&#xD;
        Also it decreases sympathetic outflow through a central action in a dose-dependent manner,&#xD;
        and these presynaptic sites of action are clinically significant because they modulate the&#xD;
        release of norepinephrine. This inhibitory effect on neurotransmitter release is mediated by&#xD;
        the blockage of calcium entry into nerve terminals. Systemic administration of the α-2&#xD;
        agonists has been tested in the perioperative period. The reduced opioid requirement was a&#xD;
        feature of the administration of such group of medications. This feature is indirect evidence&#xD;
        that these drugs have analgesic action. However, the perioperative period involves many&#xD;
        conflicting factors. Clearly, the sedative effect may be the reason behind the reduced opioid&#xD;
        requirements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of analgesia measured by visual analogue scale</measure>
      <time_frame>The first 48 hours.</time_frame>
      <description>rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>parameters of adequate ventilation and oxygenation</measure>
      <time_frame>at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.</time_frame>
      <description>PaO2/FiO2 ratio and PaCO2 will be recorded</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedation score</measure>
      <time_frame>Every 8 hours for 48 hours</time_frame>
      <description>Ramsay score was used to evaluate sedation. Score 1 represents agitated and uncomfortable patient. Score 2 represents cooperative and orientated patient. Score 3 represents a patient who can follow simple directions. Score 4 represents an asleep patient with a strong response to stimulation. Score 5 represents an asleep patient with a slow response to stimulation. Score 6 represents an asleep patient with no response to stimulation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>US-guided SAP block group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dexmedetomidine group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ultrasound-guided continuous serratus anterior plane block</intervention_name>
      <description>Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.</description>
      <arm_group_label>US-guided SAP block group</arm_group_label>
      <other_name>Group S</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>intravenous dexmedetomidine infusion</intervention_name>
      <description>Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.</description>
      <arm_group_label>Dexmedetomidine group</arm_group_label>
      <other_name>Group D</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Rib fracture score of more than 7&#xD;
  &#xD;
            -  Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists&#xD;
               classification of physical status &lt; IV&#xD;
  &#xD;
            -  Body mass index (BMI) ≤ 35.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of the patient&#xD;
  &#xD;
            -  Trauma survey include multiple injuries including head injuries, visceral and long&#xD;
               bone fractures&#xD;
  &#xD;
            -  Intubated patients&#xD;
  &#xD;
            -  Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain&#xD;
               patient, ●Hemodynamic instability&#xD;
  &#xD;
            -  Haemothorax or pneumothorax.&#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_official>
      <last_name>Dina M Fakhry, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beni-Suef University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dina M Fakhry, MD</last_name>
      <phone>+201289998680</phone>
      <email>dina_fakhry_91@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-Suef University hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni-Suef</state>
          <zip>62814</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dina M Fakhry, MD</last_name>
        <phone>+201289998680</phone>
        <email>dina_fakhry_91@yahoo.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Dina Mahmoud Fakhry</investigator_full_name>
      <investigator_title>Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management</investigator_title>
    </responsible_party>
    <keyword>Serratus anterior</keyword>
    <keyword>Dexmedetomidine</keyword>
    <keyword>Rib</keyword>
    <keyword>Fractures</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rib Fractures</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05965895
  org study id: FMBSUREC/09072023/Fakhry
  nct id: NCT05965895
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures
        who will be managed with Ultrasound-guided continuous serratus anterior plane block versus
        patients who will be managed with dexmedetomidine infusion.
  In thoracic trauma patients with rib fractures, the ability to cough and clear secretions is
        impaired by pain, leading to an increased risk of atelectasis, retention of secretions, chest
        infections and prolonged ICU stay thereby leads to significant morbidity, mortality and cost
        of treatment.Hence, aggressive pain management is a vital component of rib fracture
        management for the healing of rib fractures, improvement of pulmonary functions, and
        pulmonary rehabilitation.
  
        The number of rib fractures >3, rib fracture locations, bilateral rib fractures,
        intraparenchymal pulmonary injuries, flail chest, and a first rib fracture influence the
        mortality rates.
  
        The involvement of acute pain services in Multiple rib fractures (MRFs) is based on "Rib
        Fracture score". Rib fracture score = (breaks × sides) + age factor. "Breaks" is the total
        number of fractures to the rib. Score of 1 is for unilateral fractures and 2 for bilateral
        fractures. Age is factored into the equation due to an increased risk of complications (age
        factor = 0 if <50 years; 1 if 51-60 years; 2 if 61-70 years; 3 if 71-80 years; 4 if above 80
        years). A score >7, requires the involvement of acute pain team.
  
        There is a wide variety of strategies for treating acute pain , including multimodal opioid
        and non-opioid systemic analgesics, regional anesthesia including thoracic epidural analgesia
        (TEA), paravertebral blocks (PVB),intercostal nerve blocks and a recent expansion in the use
        of novel fascial plane blocks.
  
        Ultrasound-guided Serratus Anterior Plane (SAP) block is an ultrasound (US) guided
        interfascial plane block which has been used in managing pain due to MRFs. It is a relatively
        recent technique, first described in 2013, that provides almost complete analgesia for the
        thoracic wall by blocking the lateral branches of the intercostal nerves from T2 to L2. Two
        planes were described, one superficial to serratus anterior muscle and second underneath the
        muscle and above the rib. It is a safe, simple to perform block with no significant
        contraindications or side effects. It can be performed in patients lying supine, rendering it
        particularly useful in polytrauma patients who are unable to sit up or turn lateral for
        regional blocks on the back. It can be safely given to polytrauma patients who may be having
        hemodynamic instability or coagulopathy, unlike epidural and paravertebral. There is a
        theoretical possibility of local anesthetic toxicity and hematoma such as other interfacial
        plane blocks. Pneumothorax is a potential complication, but under ultrasound guidance, it
        would be a remote possibility as the injection is far from the pleura between two muscles or
        above the rib.
  
        Use of continuous techniques using catheters has the benefit of providing prolonged analgesia
        titrated to patient response.
  
        Dexmedetomidine is a highly selective α-2 adrenoceptor agonist. It has sympatholytic,
        sedative, amnestic, and analgesic properties. It provides a unique analgesia, without
        respiratory depression best described as opioid- sparing. The analgesic properties of α-2
        agonists are mediated by Supraspinal (locus ceruleus) and spinal (dorsal horn) mechanisms.
        Also it decreases sympathetic outflow through a central action in a dose-dependent manner,
        and these presynaptic sites of action are clinically significant because they modulate the
        release of norepinephrine. This inhibitory effect on neurotransmitter release is mediated by
        the blockage of calcium entry into nerve terminals. Systemic administration of the α-2
        agonists has been tested in the perioperative period. The reduced opioid requirement was a
        feature of the administration of such group of medications. This feature is indirect evidence
        that these drugs have analgesic action. However, the perioperative period involves many
        conflicting factors. Clearly, the sedative effect may be the reason behind the reduced opioid
        requirements.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Quality of analgesia measured by visual analogue scale
  time frame: The first 48 hours.
  description: rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.
  measure: parameters of adequate ventilation and oxygenation
  time frame: at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.
  description: PaO2/FiO2 ratio and PaCO2 will be recorded
  measure: Sedation score
  time frame: Every 8 hours for 48 hours
  description: Ramsay score was used to evaluate sedation. Score 1 represents agitated and uncomfortable patient. Score 2 represents cooperative and orientated patient. Score 3 represents a patient who can follow simple directions. Score 4 represents an asleep patient with a strong response to stimulation. Score 5 represents an asleep patient with a slow response to stimulation. Score 6 represents an asleep patient with no response to stimulation.
  arm group label: US-guided SAP block group
  arm group type: Active Comparator
  description: Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.
  arm group label: Dexmedetomidine group
  arm group type: Active Comparator
  description: Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.
  intervention type: Procedure
  intervention name: Ultrasound-guided continuous serratus anterior plane block
  description: Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.
  arm group label: US-guided SAP block group
  other name: Group S
  intervention type: Drug
  intervention name: intravenous dexmedetomidine infusion
  description: Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.
  arm group label: Dexmedetomidine group
  other name: Group D
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dina M Fakhry, MD
  role: Principal Investigator
  affiliation: Beni-Suef University
  last name: Dina M Fakhry, MD
  phone: +201289998680
  email: dina_fakhry_91@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Dina Mahmoud Fakhry
  investigator title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management
  mesh term: Rib Fractures
  mesh term: Dexmedetomidine