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Thoracic Epidural Analgesia in Flail Chest

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ClinicalTrials.gov Identifier: NCT03413059
Recruitment Status : Unknown
Verified June 2017 by Mostafa hassanien hassanien bakr, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Mostafa hassanien hassanien bakr, Assiut University

Tracking Information
First Submitted Date  ICMJE April 26, 2017
First Posted Date  ICMJE January 29, 2018
Last Update Posted Date January 29, 2018
Estimated Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2018)
visual analogue score [ Time Frame: 7 days ]
mean visual analogue score (scale of 0 to 100) indicating the severity of pain
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2018)
  • ICU stay [ Time Frame: 7 days ]
    from ICU admission to ICU discharge
  • chest infection [ Time Frame: 7 days ]
    incidence of developing chest infection
  • hospital stay [ Time Frame: 7 days ]
    length of hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracic Epidural Analgesia in Flail Chest
Official Title  ICMJE Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. 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)
  2. 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: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Flail Chest
Intervention  ICMJE
  • Drug: Morphine Sulfate
    Thoracic Epidural morphine
    Other Name: morphine
  • Drug: Triamcinolone Acetonide
    thoracic epidural triamcinolone acetonide
    Other Name: Triamcinolone
Study Arms  ICMJE
  • Active Comparator: morphine sulfate group
    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
    Intervention: Drug: Morphine Sulfate
  • Active Comparator: triamcinolone acetonide group
    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: Drug: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 21, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2018
Estimated Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03413059
Other Study ID Numbers  ICMJE IRB1000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mostafa hassanien hassanien bakr, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emad Z Saed Lecturer. ansethsia department. Faculty of medicine .assuit unveristy.
PRS Account Assiut University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP