Thoracic Epidural Analgesia in Flail Chest

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03413059

Collaborator

(none)

Enrollment

Arms

4.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 admissionGroup (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:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest

Anticipated Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

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 Names: 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 Names: Triamcinolone

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 Names:

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 Names:

Triamcinolone

Outcome Measures

Primary Outcome Measures

visual analogue score [7 days]
mean visual analogue score (scale of 0 to 100) indicating the severity of pain

Secondary Outcome Measures

ICU stay [7 days]
from ICU admission to ICU discharge
chest infection [7 days]
incidence of developing chest infection
hospital stay [7 days]
length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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