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
About this trial
This is an interventional treatment trial for Flail Chest
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
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
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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Thoracic Epidural Analgesia in Flail Chest
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