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/NCT05975294</url>
    </required_header>
    <id_info>
      <org_study_id>Soh-Med-23-07-01MD</org_study_id>
      <nct_id>NCT05975294</nct_id>
    </id_info>
    <brief_title>Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs</brief_title>
    <official_title>Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        Rib fractures are common after blunt injury to the chest. Present in 10% of blunt trauma&#xD;
        admissions. Pain associated with rib fractures can result in compromise of pulmonary function&#xD;
        causing hypoxaemia or pneumonia, which may require mechanical ventilation. Adequate relief of&#xD;
        rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions&#xD;
        effectively, which will minimise the pulmonary complications .&#xD;
  &#xD;
        Pain control is essential for not only primary pain relief but also preventing secondary&#xD;
        complications such as atelectasis or pneumonia as well as the transition to chronic pain.&#xD;
        Accordingly, further steps are now being taken from the conventional pain control medication&#xD;
        and techniques by the introduction of more aggressive pain control measures .Traditional&#xD;
        regional anaesthesia (RA) techniques such as paravertebral, intercostal and epidurals&#xD;
        injections are resource-intensive and time-consuming, limited to single dermatomes; provide&#xD;
        incomplete analgesia of the hemithorax; and are associated with significant potential&#xD;
        complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic&#xD;
        paresis and pneumothorax .&#xD;
  &#xD;
        The erector spinae plane block (ESPB) is a novel fascial plane block. Its use has been&#xD;
        documented in numerous instances with positive outcomes in controlling acute as well as&#xD;
        chronic pain. The most popular technique was the continuous infusion through a catheter .&#xD;
        Fascial plane blocks that can be used for rib fracture pain management are serratus anterior&#xD;
        plane block, erector spinae plane block and the rhomboid intercostal and subserratus (RISS)&#xD;
        block. The procedure is more simple to use with a lower incidence of complications ,less time&#xD;
        consuming , more superficial than others so it can be used in patients on anticoagulant&#xD;
        therapy .&#xD;
  &#xD;
        Providing analgesia for patients with rib fractures continues to be a management challenge.&#xD;
        Therefore, further studies are needed comparing between different techniques to prove their&#xD;
        efficacy in pain management&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>• Pulmonary function to evaluate mean change in incentive spirometry volume</measure>
      <time_frame>1 year</time_frame>
      <description>from pretreatment then 1 h after procedure then daily for 5days including: Forced expiratory volume in one second (FEV1) ,Forced vial capaciy (FVC) and The ratio of the two volumes(FEV1/FVC) and inspiratory capacity (IC).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>• VAS pain score</measure>
      <time_frame>1 year</time_frame>
      <description>will be calculated pretreatment then at 0, 0.5h, 1h, 2h , 3h ,6h, 12h and 24h thn daily for 5 days at rest and at movement.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Multiple Fracture Ribs</condition>
    <arm_group>
      <arm_group_label>Group(E):</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group (C)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>amixture 0.125% bupivicaine with fentanyl</intervention_name>
      <description>ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.</description>
      <arm_group_label>Group(E):</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset</intervention_name>
      <description>PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.</description>
      <arm_group_label>Group (C)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Age 18:60 years&#xD;
  &#xD;
                 -  Patient with 2 or more unilateral rib fractures.&#xD;
  &#xD;
                 -  ASA 1 , ASA 2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • patient refusal&#xD;
  &#xD;
                 -  History of chronic pain or daily use of analgesics&#xD;
  &#xD;
                 -  History of psychiatric disorder or inability to understand the consent form or&#xD;
                    how to use a visual analog scale (VAS) for pain measurement&#xD;
  &#xD;
                 -  Severe renal or hepatic dysfunction&#xD;
  &#xD;
                 -  Allergy to any required drug&#xD;
  &#xD;
                 -  Second thoracic surgery&#xD;
  &#xD;
                 -  Local infection at the injection site&#xD;
  &#xD;
                 -  Spinal deformity&#xD;
  &#xD;
                 -  head injury&#xD;
  &#xD;
                 -  lung complications related to trauma ( pneumothorax , haemothorax , lung&#xD;
                    collapse).&#xD;
  &#xD;
                 -  need of mechanical ventilation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>ahmed m azmy, assistant lecutrer</last_name>
      <phone>01004793896</phone>
      <email>ahmed_tosson@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>elhdad A MOUSA, professor</last_name>
    </overall_contact_backup>
    <reference>
      <citation>Truitt MS, Murry J, Amos J, Lorenzo M, Mangram A, Dunn E, Moore EE. Continuous intercostal nerve blockade for rib fractures: ready for primetime? J Trauma. 2011 Dec;71(6):1548-52; discussion 1552. doi: 10.1097/TA.0b013e31823c96e0.</citation>
      <PMID>22182865</PMID>
    </reference>
    <reference>
      <citation>Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for multiple rib fracture done by an Emergency Physician: A case series. Australas J Ultrasound Med. 2020 Aug 30;24(1):58-62. doi: 10.1002/ajum.12225. eCollection 2021 Feb.</citation>
      <PMID>34760612</PMID>
    </reference>
    <reference>
      <citation>Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.</citation>
      <PMID>25210700</PMID>
    </reference>
    <reference>
      <citation>Picard J, Meek T. Complications of regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:105-15. doi: 10.1111/j.1365-2044.2009.06205.x.</citation>
      <PMID>20377552</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Ahmed Mahmoud Azmy</investigator_full_name>
      <investigator_title>assistant lecteurer anaethesia and ICU department sohag univerisity hospital</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Rib Fractures</mesh_term>
      <mesh_term>Fractures, Multiple</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Ketorolac</mesh_term>
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Nalbuphine</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05975294
  org study id: Soh-Med-23-07-01MD
  nct id: NCT05975294
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rib fractures are common after blunt injury to the chest. Present in 10% of blunt trauma
        admissions. Pain associated with rib fractures can result in compromise of pulmonary function
        causing hypoxaemia or pneumonia, which may require mechanical ventilation. Adequate relief of
        rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions
        effectively, which will minimise the pulmonary complications .
  
        Pain control is essential for not only primary pain relief but also preventing secondary
        complications such as atelectasis or pneumonia as well as the transition to chronic pain.
        Accordingly, further steps are now being taken from the conventional pain control medication
        and techniques by the introduction of more aggressive pain control measures .Traditional
        regional anaesthesia (RA) techniques such as paravertebral, intercostal and epidurals
        injections are resource-intensive and time-consuming, limited to single dermatomes; provide
        incomplete analgesia of the hemithorax; and are associated with significant potential
        complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic
        paresis and pneumothorax .
  
        The erector spinae plane block (ESPB) is a novel fascial plane block. Its use has been
        documented in numerous instances with positive outcomes in controlling acute as well as
        chronic pain. The most popular technique was the continuous infusion through a catheter .
        Fascial plane blocks that can be used for rib fracture pain management are serratus anterior
        plane block, erector spinae plane block and the rhomboid intercostal and subserratus (RISS)
        block. The procedure is more simple to use with a lower incidence of complications ,less time
        consuming , more superficial than others so it can be used in patients on anticoagulant
        therapy .
  
        Providing analgesia for patients with rib fractures continues to be a management challenge.
        Therefore, further studies are needed comparing between different techniques to prove their
        efficacy in pain management
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: • Pulmonary function to evaluate mean change in incentive spirometry volume
  time frame: 1 year
  description: from pretreatment then 1 h after procedure then daily for 5days including: Forced expiratory volume in one second (FEV1) ,Forced vial capaciy (FVC) and The ratio of the two volumes(FEV1/FVC) and inspiratory capacity (IC).
  measure: • VAS pain score
  time frame: 1 year
  description: will be calculated pretreatment then at 0, 0.5h, 1h, 2h , 3h ,6h, 12h and 24h thn daily for 5 days at rest and at movement.
  arm group label: Group(E):
  arm group type: Active Comparator
  description: including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.
  arm group label: Group (C)
  arm group type: Active Comparator
  description: including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.
  intervention type: Drug
  intervention name: amixture 0.125% bupivicaine with fentanyl
  description: ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.
  arm group label: Group(E):
  intervention type: Drug
  intervention name: 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset
  description: PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.
  arm group label: Group (C)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: ahmed m azmy, assistant lecutrer
  phone: 01004793896
  email: ahmed_tosson@med.sohag.edu.eg
  last name: elhdad A MOUSA, professor
  citation: Truitt MS, Murry J, Amos J, Lorenzo M, Mangram A, Dunn E, Moore EE. Continuous intercostal nerve blockade for rib fractures: ready for primetime? J Trauma. 2011 Dec;71(6):1548-52; discussion 1552. doi: 10.1097/TA.0b013e31823c96e0.
  PMID: 22182865
  citation: Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for multiple rib fracture done by an Emergency Physician: A case series. Australas J Ultrasound Med. 2020 Aug 30;24(1):58-62. doi: 10.1002/ajum.12225. eCollection 2021 Feb.
  PMID: 34760612
  citation: Hwang EG, Lee Y. Effectiveness of intercostal nerve block for management of pain in rib fracture patients. J Exerc Rehabil. 2014 Aug 31;10(4):241-4. doi: 10.12965/jer.140137. eCollection 2014 Aug.
  PMID: 25210700
  citation: Picard J, Meek T. Complications of regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:105-15. doi: 10.1111/j.1365-2044.2009.06205.x.
  PMID: 20377552
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Ahmed Mahmoud Azmy
  investigator title: assistant lecteurer anaethesia and ICU department sohag univerisity hospital
  mesh term: Fractures, Bone
  mesh term: Rib Fractures
  mesh term: Fractures, Multiple
  mesh term: Dexamethasone
  mesh term: Ketorolac
  mesh term: Fentanyl
  mesh term: Nalbuphine
  mesh term: Bupivacaine
  sharing ipd: Undecided