Thoracic Epidural Analgesia in Flail Chest

Flail Chest Clinical Trial

Official title:

Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03413059
• Other study ID #: IRB1000
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: April 26, 2017
• Last updated: January 21, 2018
• Start date: February 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: mostafa H hassanein bakr, MBBCH
• Phone: +201004727908
• Email: mostafabakr566[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Flail Chest

Intervention

Drug:
• Morphine Sulfate
Thoracic Epidural morphine
• Triamcinolone Acetonide
thoracic epidural triamcinolone acetonide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue score	mean visual analogue score (scale of 0 to 100) indicating the severity of pain	7 days
Secondary	ICU stay	from ICU admission to ICU discharge	7 days
Secondary	chest infection	incidence of developing chest infection	7 days
Secondary	hospital stay	length of hospital stay	7 days