Rib FracturesNCT04863807
A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre
An observational study of Rib Fractures and Pain, Acute, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Pain, Acute
- What is being tested?
- Regional Anaesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 389 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2020to 30 Mar 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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'
Who cannot join
- Under 18 years old
- Prisoners
- Pregnant
- Private patients
- Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway'
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperiial Collge Healthcare NHS Trust
London, W2 1NY
About this study
Official title: 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
Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. However, TEA are often contraindicated due to other injuries or the use of anticoagulant medications, which also contraindicates other invasive nerve block techniques e.g. paravertebral catheters. A number of case reports have reported the safe use of alternative techniques such as Serratus Anterior Blocks (SAPB) and Erector Spinae Blocks (ESPB) and the anaesthesia community has taken them up widely based on this relatively limited evidence. In view of this, Womack et al recently published a large retrospective review examining the safety and efficacy of ultrasound guided paravertebral catheter analgesia techniques in rib fracture management along with small numbers of ESPBs. However, this data did not report the analgesic efficacy, patient reported pain relief or respiratory complications.The goal is to advance this body of evidence by reviewing our larger data set concerning the use of TEA and alternative regional techniques such as ESPB and SAPB. This comprehensive review will benefit patients by documenting the efficacy and safety of these techniques for clinicians managing rib fracture patients.
Read the 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.
- Conditions
- Rib Fractures, Pain, Acute
- Being tested
- Regional Anaesthesia
- Keywords
- epidural, erector spinae block, serratus anterior block
- Medical subject headings
- Rib Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnaesthesiaProcedure or surgery
Thoracic epidural/Erector Spinae block/Serratus Anterior block
| Study group | Role | What they receive |
|---|---|---|
| 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' Receives: Procedure: Regional Anaesthesia | |
| 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' Receives: Procedure: Regional Anaesthesia | |
| 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' Receives: Procedure: Regional Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients With a Reduction in Pain
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.
Measured: 72 hours
Secondary outcomes (6)
Opioid Consumption (mg/24h)
Data regarding type of opiate use
Measured: 72 hours
Nausea and Vomiting
The incidence of nausea in the 72 hours post block will be recorded with the number of episodes in each patient
Measured: 72 hours post block
Number of Patients With Respiratory Complication(s)'
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.
Measured: Length of stay up to 8 weeks
Intensive Care Admission
ICU admission for respiratory complications, number of days of mechanical ventilation.
Measured: Length of stay up to 8 weeks in days
Intensive Care Admission
Number of patients requiring intubation and ventilation
Measured: Length of stay up to 8 weeks in days
Number of Days of Mechanical Ventilation
Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation
Measured: Length of stay up to 8 weeks in days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start11 Nov 2020
- Primary completion4 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boyne Bellew, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863807
- Sponsor's protocol ID
- 19SM5668
- Other IDs
- 276933
- Status last verified
- Nov 2024
- First submitted
- 22 Apr 2021
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16385313Jones 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.
PubMed 21872207Adhikary 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.
PubMed 30740657Ahn 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.
PubMed 23403516Barnea 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.
PubMed 11837920Witt 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.
PubMed 29766081Womack 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.
PubMed 30687939
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04863807
- Acronym / sponsor ID
- 19SM5668
- Conditions
- Rib Fractures, Pain, Acute
- Keywords
- epidural, erector spinae block, serratus anterior block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 28 Apr 2021 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. However, TEA are often contraindicated due to other injuries or the use of anticoagulant medications, which also contraindicates other invasive nerve block techniques e.g. paravertebral catheters. A number of case reports have reported the safe use of alternative techniques such as Serratus Anterior Blocks (SAPB) and Erector Spinae Blocks (ESPB) and the anaesthesia community has taken them up widely based on this relatively limited evidence. In view of this, Womack et al recently published a large retrospective review examining the safety and efficacy of ultrasound guided paravertebral catheter analgesia techniques in rib fracture management along with small numbers of ESPBs. However, this data did not report the analgesic efficacy, patient reported pain relief or respiratory complications.The goal is to advance this body of evidence by reviewing our larger data set concerning the use of TEA and alternative regional techniques such as ESPB and SAPB. This comprehensive review will benefit patients by documenting the efficacy and safety of these techniques for clinicians managing rib fracture patients.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural for rib fracture management | – | Procedure: Regional AnaesthesiaPatients 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' |
| Erector Spinae block for rib fracture management | – | Procedure: Regional AnaesthesiaPatients 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' |
| Serratus Anterior block for rib fracture management | – | Procedure: Regional AnaesthesiaPatients 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' |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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'
Key exclusion criteria (5 listed)
- Under 18 years old
- Prisoners
- Pregnant
- Private patients
- Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional AnaesthesiaThoracic epidural/Erector Spinae block/Serratus Anterior block | Procedure or surgery | Erector Spinae block for rib fracture management, Serratus Anterior block for rib fracture management, Thoracic epidural for rib fracture management |
Primary outcome
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.
6 secondary outcomes
Opioid Consumption (mg/24h)
Time frame: 72 hours
Nausea and Vomiting
Time frame: 72 hours post block
Number of Patients With Respiratory Complication(s)'
Time frame: Length of stay up to 8 weeks
Intensive Care Admission
Time frame: 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 Days of Mechanical Ventilation
Time frame: Length of stay up to 8 weeks in days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16385313Simon 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.
- Background: PubMed 21872207Jones 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.
- Background: PubMed 30740657Adhikary 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.
- Results publication: PubMed 23403516Ahn 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.
- Results publication: PubMed 11837920Barnea 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.
- Results publication: PubMed 29766081Witt 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.
- Results publication: PubMed 30687939Womack 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boyne Bellew principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib Fractures and Pain, Acute, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients With a Reduction in Pain (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04863807, which also lists 7 linked publications.
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 15 Nov 2024.