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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

Primary Purpose

Multiple Fracture Ribs

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
amixture 0.125% bupivicaine with fentanyl
100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Fracture Ribs

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • Age 18:60 years Patient with 2 or more unilateral rib fractures. ASA 1 , ASA 2 Exclusion Criteria: • patient refusal History of chronic pain or daily use of analgesics History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement Severe renal or hepatic dysfunction Allergy to any required drug Second thoracic surgery Local infection at the injection site Spinal deformity head injury lung complications related to trauma ( pneumothorax , haemothorax , lung collapse). need of mechanical ventilation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group(E):

    Group (C)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    • Pulmonary function to evaluate mean change in incentive spirometry volume
    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).
    • VAS pain score
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    July 27, 2023
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05975294
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Fracture Ribs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group(E):
    Arm Type
    Active Comparator
    Arm 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 Title
    Group (C)
    Arm Type
    Active Comparator
    Arm 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(s)
    amixture 0.125% bupivicaine with fentanyl
    Intervention 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.
    Intervention Type
    Drug
    Intervention Name(s)
    100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    • Pulmonary function to evaluate mean change in incentive spirometry volume
    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).
    Time Frame
    1 year
    Title
    • VAS pain score
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • Age 18:60 years Patient with 2 or more unilateral rib fractures. ASA 1 , ASA 2 Exclusion Criteria: • patient refusal History of chronic pain or daily use of analgesics History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement Severe renal or hepatic dysfunction Allergy to any required drug Second thoracic surgery Local infection at the injection site Spinal deformity head injury lung complications related to trauma ( pneumothorax , haemothorax , lung collapse). need of mechanical ventilation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed m azmy, assistant lecutrer
    Phone
    01004793896
    Email
    ahmed_tosson@med.sohag.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    elhdad A MOUSA, professor

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22182865
    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.
    Results Reference
    background
    PubMed Identifier
    34760612
    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.
    Results Reference
    background
    PubMed Identifier
    25210700
    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.
    Results Reference
    background
    PubMed Identifier
    20377552
    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.
    Results Reference
    background

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    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

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