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Flail ChestPhase 2/3NCT03413059

Thoracic Epidural Analgesia in Flail Chest

A Phase 2/3 study testing Morphine Sulfate and Triamcinolone Acetonide in people with Flail Chest, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The applicability of different thoracic epidural analgesia for patients with flail chest Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Flail Chest
What is being tested?
Morphine Sulfate and Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Feb 2018to 1 Jul 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

mostafa H hassanein bakr, MBBCH contact

+201004727908

mostafabakr566@gmail.com

Emad Z Saed, MD contact

+201007046058

Emadzarief@yahoo.com

About this study

Official title: Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest

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

Read the 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
Being tested
Morphine Sulfate, Triamcinolone Acetonide
Medical subject headings
Flail Chest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Morphine SulfateDrug

    Also called morphine

    Thoracic Epidural morphine

  • Triamcinolone AcetonideDrug

    Also called Triamcinolone

    thoracic epidural triamcinolone acetonide

Study groups in NCT03413059
Study groupRoleWhat they receive
morphine sulfate groupActive comparatorpatients 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
Receives: Drug: Morphine Sulfate
triamcinolone acetonide groupActive comparatorpatients 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
Receives: Drug: Triamcinolone Acetonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. visual analogue score

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

    Measured: 7 days

Secondary outcomes (3)
  1. ICU stay

    from ICU admission to ICU discharge

    Measured: 7 days

  2. chest infection

    incidence of developing chest infection

    Measured: 7 days

  3. hospital stay

    length of hospital stay

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start1 Feb 2018 (estimated)
  3. Primary completion1 Jul 2018 (estimated)
  4. Study completion1 Jul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413059
Sponsor's protocol ID
IRB1000
Status last verified
Jun 2017
First submitted
26 Apr 2017
Last updated
29 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Morphine Sulfate and Triamcinolone Acetonide in people with Flail Chest, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mostafa H hassanein bakr, MBBCH (+201004727908, mostafabakr566@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

visual analogue score (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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