- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863807
A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre
A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre Comparing Erector Spinae Plane Blocks, Serratus Anterior Plane Blocks and Epidurals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective The primary objective is to examine whether novel fascial plane blocks, e.g. SAPB and ESPB, are effective pain relief modalities in patients with rib fractures - the proportion of patients with a reduction in pain.
Secondary Objectives
The investigators review the safety profile and complications of TEA and alternative analgesic techniques such as ESPB and SAPB used for rib fracture management in our trauma centre. In particular the effects of regional anaesthesia techniques on:
- Opioid use
- Nausea & vomiting
- Respiratory complications
- Intubation & non-invasive ventilation (NIV)
- ICU admission for respiratory complications
The investigators will assess the duration of use and complication profile of regional anaesthetic techniques, including infection, analgesic failure and damage to other structures during insertion e.g. the lung.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W2 1NY
- Imperiial Collge Healthcare NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
- Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years
- Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway' (see Appendix A)
Description
Inclusion Criteria:
- Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years
- Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'
Exclusion Criteria:
- Under 18 years old
- Prisoners
- Pregnant
- Private patients
- Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway'
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Thoracic epidural for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare National Health Service (NHS) Trust 'Invasive rib fracture management pathway'
|
Thoracic epidural/Erector Spinae block/Serratus Anterior block
|
|
Erector Spinae block for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'
|
Thoracic epidural/Erector Spinae block/Serratus Anterior block
|
|
Serratus Anterior block for rib fracture management
Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years that meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway'
|
Thoracic epidural/Erector Spinae block/Serratus Anterior block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Proportion of Patients With a Reduction in Pain
Time Frame: 72 hours
|
The investigators will review pain scores as recorded by clinical staff over 72 hours to assess pain relief efficacy, A verbal rating scale classifying pain as mild, moderate or severe is used at Imperial Data from the acute pain round records will also provide details regarding breathing comfort levels of the patient, coughing ability and deep inspiratory effort.
These are recorded as yes/no answers and the team will assess the proportion of patients showing a reduction in pain scores.
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Consumption (mg/24h)
Time Frame: 72 hours
|
Data regarding type of opiate use
|
72 hours
|
|
Nausea and Vomiting
Time Frame: 72 hours post block
|
The incidence of nausea in the 72 hours post block will be recorded with the number of episodes in each patient
|
72 hours post block
|
|
Number of Patients With Respiratory Complication(s)'
Time Frame: Length of stay up to 8 weeks
|
Lower respiratory tract infections: defined as raised CRP/ White Cell Count, new consolidation on CXR or antibiotics being started at clinician discretion. Empyema or parapneumonic effusions: defined as radiological evidence of fluid collections within the pleural space and therapeutic interventions required for treatment e.g. aspiration and drainage. |
Length of stay up to 8 weeks
|
|
Intensive Care Admission
Time Frame: Length of stay up to 8 weeks in days
|
ICU admission for respiratory complications, number of days of mechanical ventilation.
|
Length of stay up to 8 weeks in days
|
|
Intensive Care Admission
Time Frame: Length of stay up to 8 weeks in days
|
Number of patients requiring intubation and ventilation
|
Length of stay up to 8 weeks in days
|
|
Number of Days of Mechanical Ventilation
Time Frame: Length of stay up to 8 weeks in days
|
Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation
|
Length of stay up to 8 weeks in days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Boyne Bellew, Imperial College Healthcare NHS Trust
Publications and helpful links
General Publications
- Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67. doi: 10.1097/01.ta.0000178063.77946.f5. No abstract available.
- Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub 2019 Feb 10.
- Ahn Y, Gorlinger K, Alam HB, Eikermann M. Pain-associated respiratory failure in chest trauma. Anesthesiology. 2013 Mar;118(3):701-8. doi: 10.1097/ALN.0b013e318283996b. No abstract available.
- Jones KM, Reed RL 2nd, Luchette FA. The ribs or not the ribs: which influences mortality? Am J Surg. 2011 Nov;202(5):598-604. doi: 10.1016/j.amjsurg.2010.09.029. Epub 2011 Aug 26.
- Barnea Y, Kashtan H, Skornick Y, Werbin N. Isolated rib fractures in elderly patients: mortality and morbidity. Can J Surg. 2002 Feb;45(1):43-6.
- Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016-000064. eCollection 2017.
- Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 May;74(5):594-601. doi: 10.1111/anae.14580. Epub 2019 Jan 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19SM5668
- 276933 (Other Identifier: HRA and Health and Care Research Wales (HCRW))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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