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| ID | Type | Description | Link |
|---|---|---|---|
| 276933 | Other Identifier | HRA and Health and Care Research Wales (HCRW) |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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' |
| |
| 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' |
| |
| 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' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anaesthesia | Procedure | Thoracic epidural/Erector Spinae block/Serratus Anterior block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (mg/24h) | Data regarding type of opiate use | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boyne Bellew | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperiial Collge Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16385313 | Background | 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. | |
| 21872207 | Background |
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Records will be identified by searching the Trauma Audit and Research Network database, routinely collected database of all patients admitted with traumatic injury within the Imperial College Healthcare Trust. The study will be conducted from 11/11/2020 until the 31/01/2023. We plan to review rib injured patient's electronic notes that have received these interventions from January 2016 until December 2019 and categorise the information for analysis as set out in study outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| FG001 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| FG002 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 72 hours |
|
Duration of hospital admission
389 participants were included, 6 patients had >1 block during their inpatient stay but did not affect their participation in the trial and/or the collection of results, therefore 389 patients.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICU admission for respiratory complication | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alex Wickham | Imperial College Healthcare NHS Trust | +4420233121248 | alex.wickham@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2020 | Mar 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| 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. | Length of stay up to 8 weeks |
| Intensive Care Admission | ICU admission for respiratory complications, number of days of mechanical ventilation. | Length of stay up to 8 weeks in days |
| Intensive Care Admission | Number of patients requiring intubation and ventilation | 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 | Length of stay up to 8 weeks in days |
| 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. |
| 30740657 | Background | 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. |
| 23403516 | Result | 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. |
| 11837920 | Result | 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. |
| 29766081 | Result | 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. |
| 30687939 | Result | 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. |
| BG001 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| BG002 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
| OG002 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block |
|
|
| Secondary | Opioid Consumption (mg/24h) | Data regarding type of opiate use | Posted | Median | Inter-Quartile Range | 24hr opioid consumption (mg) | 72 hours |
|
|
|
| Secondary | Nausea and Vomiting | The incidence of nausea in the 72 hours post block will be recorded with the number of episodes in each patient | Posted | Count of Participants | Participants | 72 hours post block |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Length of stay up to 8 weeks |
|
|
|
| Secondary | Intensive Care Admission | ICU admission for respiratory complications, number of days of mechanical ventilation. | Posted | Count of Participants | Participants | Length of stay up to 8 weeks in days |
|
|
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| Secondary | Intensive Care Admission | Number of patients requiring intubation and ventilation | Posted | Count of Participants | Participants | Length of stay up to 8 weeks in days |
|
|
|
| Secondary | Number of Days of Mechanical Ventilation | Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation | Posted | Median | Full Range | days | Length of stay up to 8 weeks in days |
|
|
|
| 9 |
| 325 |
| 206 |
| 325 |
| 0 |
| 325 |
| EG001 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block | 2 | 38 | 14 | 26 | 0 | 26 |
| EG002 | 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' Regional Anaesthesia: Thoracic epidural/Erector Spinae block/Serratus Anterior block | 3 | 26 | 22 | 38 | 0 | 38 |
| Intubation & Mechanical Ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Any lung complication | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|