Thoracic Epidural Analgesia in Flail Chest

NCT ID: NCT03413059

Last Updated: 2018-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-07-01

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.

Conditions

Flail Chest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Morphine Sulfate

Intervention Type: DRUG

Thoracic Epidural morphine

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

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: DRUG

thoracic epidural triamcinolone acetonide

Interventions

Morphine Sulfate

Thoracic Epidural morphine

Intervention Type: DRUG

Triamcinolone Acetonide

thoracic epidural triamcinolone acetonide

Intervention Type: DRUG

Other Intervention Names

morphine; Triamcinolone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mostafa hassanien hassanien bakr

assitent lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emad Z Saed

Role: PRINCIPAL_INVESTIGATOR

Lecturer. ansethsia department. Faculty of medicine .assuit unveristy.

Central Contacts

mostafa H hassanein bakr, MBBCH

Role: CONTACT

mostafabakr566@gmail.com

+201004727908

Emad Z Saed, MD

Role: CONTACT

Emadzarief@yahoo.com

+201007046058

Other Identifiers

IRB1000

Identifier Type: -

Identifier Source: org_study_id