Thoracic Epidural Analgesia in Flail Chest

NCT03413059 | Unknown Phase 2 DMC

• 1 other identifier: IRB1000
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Flail Chest

Outcome Measures

Primary Outcomes (1)

• visual analogue score

  mean visual analogue score (scale of 0 to 100) indicating the severity of pain

  7 days

Secondary Outcomes (3)

• ICU stay

  7 days

• chest infection

  7 days

• hospital stay

  7 days

Study Arms (2)

morphine sulfate group

ACTIVE COMPARATOR

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

triamcinolone acetonide group

ACTIVE COMPARATOR

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

Interventions

Morphine Sulfate DRUG

Thoracic Epidural morphine

Also known as: morphine

morphine sulfate group

Triamcinolone Acetonide DRUG

thoracic epidural triamcinolone acetonide

Also known as: Triamcinolone

triamcinolone acetonide group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Flail Chest

Interventions

Morphine; Triamcinolone Acetonide; Triamcinolone

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Emad Z Saed

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mostafa H hassanein bakr, MBBCH

CONTACT

+201004727908; mostafabakr566@gmail.com

Emad Z Saed, MD

CONTACT

+201007046058; Emadzarief@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assitent lecturer

Model Details: 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

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: January 29, 2018
• Study Start: February 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 29, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share