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Thoracic Epidural Analgesia in Flail Chest

Primary Purpose

Flail Chest

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Morphine Sulfate
Triamcinolone Acetonide
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flail Chest

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 18 years.
  • American Society of Anesthesiologists physical status 1 or 2.
  • mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

  • Patient refusal.
  • Psychiatric disorder
  • Patient younger than 18 years old
  • Allergy to local anesthetics, systemic opioids (fentanyl, morphine)
  • Impaired kidney functions and patient with coagulopathy will be also excluded.
  • Chronic pain syndromes and patients with chronic opioid use defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
  • BMI of 40 or more

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    morphine sulfate group

    triamcinolone acetonide group

    Arm Description

    patients in this arm will receive : morphine dose 0.1mg /kg with 9 ml of 0.25 % bupivacaine with through epidural catheter on admission Then continuous epidural infusion of bupivacaine (0.1 mg.kg-1.h) 1st 72 hours

    patients in this arm will receive will receive a mixture of 9 ml of 0.125 % bupivacaine with 80mg of triamcinolone ( 10 ml total volume) through epidural catheter on admission

    Outcomes

    Primary Outcome Measures

    visual analogue score
    mean visual analogue score (scale of 0 to 100) indicating the severity of pain

    Secondary Outcome Measures

    ICU stay
    from ICU admission to ICU discharge
    chest infection
    incidence of developing chest infection
    hospital stay
    length of hospital stay

    Full Information

    First Posted
    April 26, 2017
    Last Updated
    January 21, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03413059
    Brief Title
    Thoracic Epidural Analgesia in Flail Chest
    Official Title
    Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2018 (Anticipated)
    Primary Completion Date
    July 1, 2018 (Anticipated)
    Study Completion Date
    July 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The applicability of different thoracic epidural analgesia for patients with flail chest
    Detailed Description
    Pain due to traumatic rib fractures may be associated with increased morbidity and mortality. Fracture ribs cause severe pain that adversely affects patients' ability to cough and breathe deeply, that may lead to decreased ventilator efforts, atelectasis, pneumonia and finally respiratory failure. That further results in longer intensive care unit (ICU) and hospital length of stay and higher mortality. Effective pain relief, chest physiotherapy and respiratory care are the points of management. Effective analgesia enables the patient to breathe deeply, cough out the secretions and comply with chest physiotherapy. Multiple pain relief treatment options are available, such as oral analgesics, intravenous opioids, patient-controlled opioid analgesia, interpleural blocks, intercostals blocks, para vertebral blocks, and epidural analgesia Recent studies reported that epidural analgesia reduces morbidity after major thoracic, abdominal and vascular surgeries, but in patients with rib fractures, Successful treatment for rib fracture pain usually requires both pharmacologic and interventional approaches .Single modality treatment, which may incite respiratory depression, is suboptimal in these patients, many of whom already manifest a compromised respiratory system. Interventional procedures, while opioid sparing, carry their own inherent risks. Intercostals nerve blocks may not be feasible in the setting of multiple rib fractures, because of patient discomfort and the risk of local aesthetic toxicity. Use of an epidural catheter with continuous infusion of local anaesthetics and opioids may pose challenges in a community hospital setting, as 24 hours in-house coverage is often unavailable. While single-shot thoracic epidural steroid injections have been used for herniated intervertebral discs, herpes zoster pain, and post herpetic neuralgia (PHN), their use in patients with rib fracture pain has not been previously reported in the literature. An epidural steroid injection delivers steroids directly into the epidural space in the spine. Sometimes additional fluid (local aesthetic and/or a normal saline solution) is used to help 'flush out' inflammatory mediators from around the area that may be a source of pain ..Typically, a solution containing cortisone (steroid) with local aesthetic (lidocaine or bupivacaine), and/or saline is used.A steroid, or cortisone, is usually injected as an anti-inflammatory agent. Inflammation is a common component of many low back conditions and reducing inflammation helps reduce pain. Triamcinolone acetonide, Dexamethasone, and Methyl prednisolone acetate are commonly used steroids.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flail Chest

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group (m): which will receive morphine dose 0.1mg /kg with 9 ml of 0.125 % bupivacaine with through epidural catheter in T 7-T10 .on admission. Then continuous epidural infusion of bupivacaine (0.1 mg.kg-1.h) Group (s) : will receive mixture consisting of 9 ml of 0.125 % bupivacaine with 80mg of triamcinolone ( 10 ml total volume) .through epidural catheter in-T7- T10 .on admission
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    morphine sulfate group
    Arm Type
    Active Comparator
    Arm Description
    patients in this arm will receive : morphine dose 0.1mg /kg with 9 ml of 0.25 % bupivacaine with through epidural catheter on admission Then continuous epidural infusion of bupivacaine (0.1 mg.kg-1.h) 1st 72 hours
    Arm Title
    triamcinolone acetonide group
    Arm Type
    Active Comparator
    Arm Description
    patients in this arm will receive will receive a mixture of 9 ml of 0.125 % bupivacaine with 80mg of triamcinolone ( 10 ml total volume) through epidural catheter on admission
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine Sulfate
    Other Intervention Name(s)
    morphine
    Intervention Description
    Thoracic Epidural morphine
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Acetonide
    Other Intervention Name(s)
    Triamcinolone
    Intervention Description
    thoracic epidural triamcinolone acetonide
    Primary Outcome Measure Information:
    Title
    visual analogue score
    Description
    mean visual analogue score (scale of 0 to 100) indicating the severity of pain
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    ICU stay
    Description
    from ICU admission to ICU discharge
    Time Frame
    7 days
    Title
    chest infection
    Description
    incidence of developing chest infection
    Time Frame
    7 days
    Title
    hospital stay
    Description
    length of hospital stay
    Time Frame
    7 days

    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: Older than 18 years. American Society of Anesthesiologists physical status 1 or 2. mentally competent and able to give consent for enrollment in the study Exclusion Criteria: Patient refusal. Psychiatric disorder Patient younger than 18 years old Allergy to local anesthetics, systemic opioids (fentanyl, morphine) Impaired kidney functions and patient with coagulopathy will be also excluded. Chronic pain syndromes and patients with chronic opioid use defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery. BMI of 40 or more
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mostafa H hassanein bakr, MBBCH
    Phone
    +201004727908
    Email
    mostafabakr566@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emad Z Saed, MD
    Phone
    +201007046058
    Email
    Emadzarief@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emad Z Saed
    Organizational Affiliation
    Lecturer. ansethsia department. Faculty of medicine .assuit unveristy.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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