Trial Outcomes & Findings for A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre (NCT NCT04863807)
NCT ID: NCT04863807
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
389 participants
Primary outcome timeframe
72 hours
Results posted on
2024-11-15
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
325
|
26
|
38
|
|
Overall Study
COMPLETED
|
325
|
26
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=325 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=389 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
166 Participants
n=325 Participants
|
7 Participants
n=26 Participants
|
12 Participants
n=38 Participants
|
185 Participants
n=389 Participants
|
|
Age, Categorical
>=65 years
|
159 Participants
n=325 Participants
|
19 Participants
n=26 Participants
|
26 Participants
n=38 Participants
|
204 Participants
n=389 Participants
|
|
Age, Continuous
|
63 years
n=325 Participants
|
76 years
n=26 Participants
|
69 years
n=38 Participants
|
66 years
n=389 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=325 Participants
|
8 Participants
n=26 Participants
|
18 Participants
n=38 Participants
|
133 Participants
n=389 Participants
|
|
Sex: Female, Male
Male
|
218 Participants
n=325 Participants
|
18 Participants
n=26 Participants
|
20 Participants
n=38 Participants
|
256 Participants
n=389 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
325 participants
n=325 Participants
|
26 participants
n=26 Participants
|
38 participants
n=38 Participants
|
389 participants
n=389 Participants
|
PRIMARY outcome
Timeframe: 72 hoursThe 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.
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
The Proportion of Patients With a Reduction in Pain
|
6 Participants
|
15 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 72 hoursData regarding type of opiate use
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Opioid Consumption (mg/24h)
|
15 24hr opioid consumption (mg)
Interval 3.1 to 41.8
|
10 24hr opioid consumption (mg)
Interval 0.0 to 18.8
|
0 24hr opioid consumption (mg)
Interval 0.0 to 7.9
|
SECONDARY outcome
Timeframe: 72 hours post blockThe incidence of nausea in the 72 hours post block will be recorded with the number of episodes in each patient
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Nausea and Vomiting
|
10 Participants
|
2 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: Length of stay up to 8 weeksLower 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.
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Number of Patients With Respiratory Complication(s)'
|
10 Participants
|
13 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Length of stay up to 8 weeks in daysICU admission for respiratory complications, number of days of mechanical ventilation.
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Intensive Care Admission
|
2 Participants
|
6 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Length of stay up to 8 weeks in daysNumber of patients requiring intubation and ventilation
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Intensive Care Admission
|
1 Participants
|
2 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Length of stay up to 8 weeks in daysNumber of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation
Outcome measures
| Measure |
Erector Spinae Block for Rib Fracture Management
n=26 Participants
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 Participants
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
|
Thoracic Epidural for Rib Fracture Management
n=325 Participants
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
|
|---|---|---|---|
|
Number of Days of Mechanical Ventilation
|
0 days
Interval 0.0 to 11.0
|
0 days
Interval 0.0 to 9.0
|
0 days
Interval 0.0 to 45.0
|
Adverse Events
Thoracic Epidural for Rib Fracture Management
Serious events: 206 serious events
Other events: 0 other events
Deaths: 9 deaths
Erector Spinae Block for Rib Fracture Management
Serious events: 14 serious events
Other events: 0 other events
Deaths: 2 deaths
Serratus Anterior Block for Rib Fracture Management
Serious events: 22 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Thoracic Epidural for Rib Fracture Management
n=325 participants at risk
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
|
Erector Spinae Block for Rib Fracture Management
n=26 participants at risk
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
|
Serratus Anterior Block for Rib Fracture Management
n=38 participants at risk
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
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ICU admission for respiratory complication
|
20.3%
66/325 • 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.
|
11.5%
3/26 • 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.
|
18.4%
7/38 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Intubation & Mechanical Ventilation
|
9.2%
30/325 • 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.
|
3.8%
1/26 • 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.
|
5.3%
2/38 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Any lung complication
|
33.8%
110/325 • 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.
|
38.5%
10/26 • 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.
|
34.2%
13/38 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Alex Wickham
Imperial College Healthcare NHS Trust
Phone: +4420233121248
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place