Pain, Acute, Rib Fractures
Conditions
Keywords
epidural, erector spinae block, serratus anterior block
Brief 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. 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: 1. Opioid use 2. Nausea & vomiting 3. Respiratory complications 4. Intubation & non-invasive ventilation (NIV) 5. 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.
Interventions
PROCEDURERegional Anaesthesia
Thoracic epidural/Erector Spinae block/Serratus Anterior block
Sponsors
Imperial College Healthcare NHS Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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'
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Patients With a Reduction in Pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (mg/24h) | 72 hours | Data regarding type of opiate use |
| Nausea and Vomiting | 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 |
| Number of Patients With Respiratory Complication(s)' | 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. |
| Intensive Care Admission | Length of stay up to 8 weeks in days | ICU admission for respiratory complications, number of days of mechanical ventilation. |
| Number of Days of Mechanical Ventilation | Length of stay up to 8 weeks in days | Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 325 |
| 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 | 26 |
| 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 | 38 |
| Total | 389 |
Baseline characteristics
| Characteristic | Erector Spinae Block for Rib Fracture Management | Serratus Anterior Block for Rib Fracture Management | Thoracic Epidural for Rib Fracture Management | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 26 Participants | 159 Participants | 204 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 12 Participants | 166 Participants | 185 Participants |
| Age, Continuous | 76 years | 69 years | 63 years | 66 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United Kingdom | 26 participants | 38 participants | 325 participants | 389 participants |
| Sex: Female, Male Female | 8 Participants | 18 Participants | 107 Participants | 133 Participants |
| Sex: Female, Male Male | 18 Participants | 20 Participants | 218 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 9 / 325 | 2 / 38 | 3 / 26 |
| other Total, other adverse events | 0 / 325 | 0 / 26 | 0 / 38 |
| serious Total, serious adverse events | 206 / 325 | 14 / 26 | 22 / 38 |
Outcome results
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.
Time frame: 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | The Proportion of Patients With a Reduction in Pain | 101 Participants |
| Erector Spinae Block for Rib Fracture Management | The Proportion of Patients With a Reduction in Pain | 6 Participants |
| Serratus Anterior Block for Rib Fracture Management | The Proportion of Patients With a Reduction in Pain | 15 Participants |
Secondary
Intensive Care Admission
Number of patients requiring intubation and ventilation
Time frame: Length of stay up to 8 weeks in days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Intensive Care Admission | 30 Participants |
| Erector Spinae Block for Rib Fracture Management | Intensive Care Admission | 1 Participants |
| Serratus Anterior Block for Rib Fracture Management | Intensive Care Admission | 2 Participants |
Secondary
Intensive Care Admission
ICU admission for respiratory complications, number of days of mechanical ventilation.
Time frame: Length of stay up to 8 weeks in days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Intensive Care Admission | 44 Participants |
| Erector Spinae Block for Rib Fracture Management | Intensive Care Admission | 2 Participants |
| Serratus Anterior Block for Rib Fracture Management | Intensive Care Admission | 6 Participants |
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
Time frame: 72 hours post block
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Nausea and Vomiting | 117 Participants |
| Erector Spinae Block for Rib Fracture Management | Nausea and Vomiting | 10 Participants |
| Serratus Anterior Block for Rib Fracture Management | Nausea and Vomiting | 2 Participants |
Secondary
Number of Days of Mechanical Ventilation
Number of days of mechanical ventilation for patients undergoing Intensive care mechanical ventilation
Time frame: Length of stay up to 8 weeks in days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Number of Days of Mechanical Ventilation | 0 days |
| Erector Spinae Block for Rib Fracture Management | Number of Days of Mechanical Ventilation | 0 days |
| Serratus Anterior Block for Rib Fracture Management | Number of Days of Mechanical Ventilation | 0 days |
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.
Time frame: Length of stay up to 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Number of Patients With Respiratory Complication(s)' | 110 Participants |
| Erector Spinae Block for Rib Fracture Management | Number of Patients With Respiratory Complication(s)' | 10 Participants |
| Serratus Anterior Block for Rib Fracture Management | Number of Patients With Respiratory Complication(s)' | 13 Participants |
Secondary
Opioid Consumption (mg/24h)
Data regarding type of opiate use
Time frame: 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thoracic Epidural for Rib Fracture Management | Opioid Consumption (mg/24h) | 0 24hr opioid consumption (mg) |
| Erector Spinae Block for Rib Fracture Management | Opioid Consumption (mg/24h) | 15 24hr opioid consumption (mg) |
| Serratus Anterior Block for Rib Fracture Management | Opioid Consumption (mg/24h) | 10 24hr opioid consumption (mg) |