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Thoracic Epidural Analgesia in Flail Chest

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ClinicalTrials.gov Identifier: NCT03413059
Recruitment Status : 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

Brief Summary:
The applicability of different thoracic epidural analgesia for patients with flail chest

Condition or disease Intervention/treatment Phase
Flail Chest Drug: Morphine Sulfate Drug: Triamcinolone Acetonide Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 1, 2018
Estimated Study Completion Date : July 1, 2018


Arm Intervention/treatment
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
Drug: Morphine Sulfate
Thoracic Epidural morphine
Other Name: morphine

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
Drug: Triamcinolone Acetonide
thoracic epidural triamcinolone acetonide
Other Name: Triamcinolone




Primary Outcome Measures :
  1. visual analogue score [ Time Frame: 7 days ]
    mean visual analogue score (scale of 0 to 100) indicating the severity of pain


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 7 days ]
    from ICU admission to ICU discharge

  2. chest infection [ Time Frame: 7 days ]
    incidence of developing chest infection

  3. hospital stay [ Time Frame: 7 days ]
    length of hospital stay



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413059


Contacts
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Contact: mostafa H hassanein bakr, MBBCH +201004727908 mostafabakr566@gmail.com
Contact: Emad Z Saed, MD +201007046058 Emadzarief@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Emad Z Saed Lecturer. ansethsia department. Faculty of medicine .assuit unveristy.

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Responsible Party: Mostafa hassanien hassanien bakr, assitent lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03413059     History of Changes
Other Study ID Numbers: IRB1000
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Flail Chest
Thoracic Injuries
Wounds and Injuries
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action