Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000040864
Ethics application status
Approved
Date submitted
30/09/2020
Date registered
18/01/2021
Date last updated
11/07/2022
Date data sharing statement initially provided
18/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Serratus Anterior Plane Blocks for Rib Fractures in the Emergency Department - the SABRE trial
Scientific title
Serratus anterior plane block in addition to protocolised care bundles for rib fracture associated pain management in the Emergency Department - a randomised control study.
Secondary ID [1] 302316 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
The SABRE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 319127 0
Thoracic trauma 319128 0
Condition category
Condition code
Emergency medicine 317090 317090 0 0
Other emergency care
Injuries and Accidents 317091 317091 0 0
Fractures
Anaesthesiology 317092 317092 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention itself is a serratus anterior plane block (SAPB).

The SAPB is an ultrasound-guided, regional anaesthesia technique that provides analgesia to most of the hemithorax by the use of a once-only, local anaesthetic (ropivacaine) injection performed in the axillary region. Local anaesthetic inserted into the serratus anterior plane spreads throughout the lateral chest wall, resulting in paraesthesia of the T2 through T9 dermatomes of the anterolateral thorax by blocking the lateral cutaneous branches of the thoracic intercostal nerves.

It will be performed by senior clinicians (specialists or advanced trainees) in the Emergency Department.

This intervention (including risks & benefits) has been described in more detail under "Interventions" on pages 8 & 9 as well as Appendix B of the Study Protocol which includes a weight-based ropivacaine dosing guide (Table 1) consistent with current NSW guidelines for fascia iliaca blocks.

Blocks will be recorded in the electronic medical record and in the standardised case reporting form (on REDCap) in which clinicians must report type and dose of anaesthetic administered, volume of the diluent and which serratus plane was utilised (superficial vs deep). This will allow investigators to monitor for protocol adherence.

Patients in the intervention arm also receive the "local protocolised, rib-fracture bundle of care" described below.
Intervention code [1] 318720 0
Treatment: Other
Comparator / control treatment
The control group receives the protocolised, rib-fracture bundle of care which represents the current best-practice, standard of care for these injuries. This is already established practice at the participating hospitals each with their own hospital or local-health-district policies. They include regular and 'as required' pain relief, typically in the form of intravenous patient-controlled opiates, oxygen monitoring, physiotherapy and early mobilisation.

The policies from our contributing sites have been summarised in Appendix A "Summary of rib fracture pathways at participating SABRE sites" of the Study Protocol.
A summary of these care pathways can be found in Appendix A of the Study Protocol.
Control group
Active

Outcomes
Primary outcome [1] 325286 0
A pain score reduction of two or more points AND have an absolute pain score of less than four out of ten (measured by a verbally administered numerical rating scale, or PAINAD score in patients with dementia)
Timepoint [1] 325286 0
Four hours from study enrolment
Secondary outcome [1] 387394 0
Change in pain scores from baseline pain (measured by a verbally administered numerical rating scale, or PAINAD score in patients with dementia)
Timepoint [1] 387394 0
12 hours from study enrolment
Secondary outcome [2] 387395 0
Change in pain scores from baseline pain (measured by a verbally administered numerical rating scale, or PAINAD score in patients with dementia)
Timepoint [2] 387395 0
24 hours from study enrolment
Secondary outcome [3] 387396 0
Total opiate administration (morphine milligram equivalents)
(via review of electronic medical record, paper-based medication chart and/or PCA chart review)
Timepoint [3] 387396 0
First 24 hours of initial hospital admission
Secondary outcome [4] 387397 0
Rates of pneumonia occurrence (defined by radiological evidence of pulmonary air-space opacification, together
with medical record documentation of a clinical diagnosis of pneumonia and treatment with
antibiotics)
Timepoint [4] 387397 0
7 days from initial hospital admission
Secondary outcome [5] 387398 0
Delirium (measured by the '4AT Rapid Clinical Test')
Timepoint [5] 387398 0
2 days from initial hospital admission
Secondary outcome [6] 387399 0
Local anaesthetic systemic toxicity (LAST) defined by severe neurologic or cardiovascular symptoms (such as seizures, agitation, cardiac dysrhythmias and hypotension)
(via review of electronic medical record)
Timepoint [6] 387399 0
Within one hour of local anaesthetic administration
Secondary outcome [7] 387400 0
Rates of non-invasive ventilation assessed by any need of CPAP/BiPAP via review of electronic medical record
Timepoint [7] 387400 0
7 days from initial hospital admission
Secondary outcome [8] 387401 0
Rates of regional anaesthesia administered by inpatient pain service
(via review of electronic medical record)
Timepoint [8] 387401 0
7 days from initial hospital admission
Secondary outcome [9] 387402 0
Quality of life (measured by the EQ-5D-5L questionnaire)
Timepoint [9] 387402 0
30 days post-injury
Secondary outcome [10] 387403 0
Mortality
(via review of electronic medical record)
Timepoint [10] 387403 0
30 days post-injury
Secondary outcome [11] 387404 0
Hospital length of stay
(via review of electronic medical record)
Timepoint [11] 387404 0
until 3 months post-injury
Secondary outcome [12] 387405 0
ICU length of stay
(via review of electronic medical record)
Timepoint [12] 387405 0
until 3 months post-injury
Secondary outcome [13] 389562 0
Rates of mechanical ventilation assessed by any need for endotracheal intubation via review of electronic medical record.
Timepoint [13] 389562 0
7 days from initial hospital admission
Secondary outcome [14] 389563 0
Rates of new pneumothoraces (identified on subsequent imaging (either CXR or thoracic CT), post-SAPB following no-pneumothorax on initial imaging)
Timepoint [14] 389563 0
within 2 days of SAPB

Eligibility
Key inclusion criteria
All patients aged 16 years or older with clinical or radiologically proven rib fractures, and a clinician qualified to perform SAPB available at time of enrolment
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Intubated patients
- Patients who have a prehospital SAPB
- Pregnant women
- Patients transferred for urgent surgical intervention
- Moderate-severe traumatic brain injury (GCS less than or equal to 13)
- Major concomitant injury identified on imaging (including Femoral fracture, Pelvic fracture, Spinal fracture, Intra-abdominal visceral injury ± free fluid)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Given the nature of the intervention, we do not believe it is possible to conceal the treatment (serratus anterior plane block) from either the patients or the treating bedside clinicians (medical and nursing staff), as such we have listed this as an open-label trial. It is routine practice to closely observe patients who undergo local anaesthetic blocks for a period of time to watch for complications or side effects of the procedure, and we are required to do the same for these patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised 1:1 to one of the two groups: SAPB plus protocolised rib fracture pathway management (intervention) or protocolised rib fracture pathway management alone (control).

Randomisation will occur in blocks of various sizes (2,4,6) and will be stratified by participating hospital.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Patients will be analysed according to their randomised treatment allocation receiving the Serratus anterior plane block in the emergency department (SAPB) or not receiving the block (NSAPB), i.e. using an Intention to Treat (ITT) analysis. Demographic data including age, sex, BMI of patient, co-morbidities (e.g. COPD, heart failure and injury score), will be compared between groups using a t-test or non-parametric equivalent for continuous data and chi-square analysis for categorical data. The central tendency and distribution of normally distributed data will be described with means and 95% confidence intervals, and non-normally distributed data with medians and interquartile range.

Patients will be categorised according to whether or not they meet the primary outcome criteria for pain reduction (reduction of two or more points from baseline to 4 hour measure and an absolute pain score of less than four out of ten at 4 hours). The primary outcome measure will be coded as “0” if patients do not meet the criteria and “1” if they do meet the criteria. Comparison of the dichotomised results will be made between the groups (SAPB and NSAPB) and presented as relative risk and absolute relative risk reduction. The study is powered to test if the SAPB is superior to NSAPB.

Separate multivariable regressions will be conducted to explore the relationship between group and change in the dependent variables (a) pain score or (b) in total opioid use from baseline to 4 hours. In addition to group (SAPB or NSAPB) as the independent variable, these models will also control for patient factors (age, sex, Charlson Comorbidity Index, rib fracture numbers, BMI, type of oxygen delivery); and site factors (hospital and CHIP pathway type).

Comparisons between groups (SAPB and NSAPB) on the frequency of complications (opioid related, pulmonary, delirium and LAST) will be performed using chi-square analyses. The following outcome measurements will be compared between the two groups; analgesic use (opiate requirements), procedural complications (LAST and pneumothorax), opioid associated side effects and respiratory complications (including pneumonia, need for oxygen therapy/mechanical support). Patients allocated to the control arm may receive a SAPB as a component of rescue analgesic management. As a result, all secondary outcomes will be analysed using both intention to treat (ITT) and per protocol approaches.

P values < 0.05 will be considered indicative of statistical significance and all analyses will be performed using IBM SPSS software. An interim analysis will be performed six months into the study period to ensure patient safety and appropriate recruitment trajectory is being maintained.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2021
Actual
12/04/2021
Date of last participant enrolment
Anticipated
31/01/2022
Actual
22/01/2022
Date of last data collection
Anticipated
1/06/2022
Actual
13/06/2022
Sample size
Target
210
Accrual to date
Final
210
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17705 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 17706 0
St George Hospital - Kogarah
Recruitment hospital [3] 17707 0
Orange Health Service - Orange
Recruitment hospital [4] 17708 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [5] 17709 0
The Sutherland Hospital - Caringbah
Recruitment hospital [6] 17710 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [7] 18154 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [8] 18155 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 31560 0
2170 - Liverpool
Recruitment postcode(s) [2] 31561 0
2217 - Kogarah
Recruitment postcode(s) [3] 31562 0
2800 - Orange
Recruitment postcode(s) [4] 31563 0
2560 - Campbelltown
Recruitment postcode(s) [5] 31564 0
2229 - Caringbah
Recruitment postcode(s) [6] 31565 0
2086 - Frenchs Forest
Recruitment postcode(s) [7] 32151 0
2050 - Camperdown
Recruitment postcode(s) [8] 32152 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 306742 0
Government body
Name [1] 306742 0
NSW Institute of Trauma and Injury Management
Country [1] 306742 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 307291 0
None
Name [1] 307291 0
Address [1] 307291 0
Country [1] 307291 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306914 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306914 0
Ethics committee country [1] 306914 0
Australia
Date submitted for ethics approval [1] 306914 0
30/09/2020
Approval date [1] 306914 0
09/12/2020
Ethics approval number [1] 306914 0
2020/ETH02516

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105430 0
Dr Christopher Partyka
Address 105430 0
Emergency Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 105430 0
Australia
Phone 105430 0
+612 8738 3950
Fax 105430 0
Email 105430 0
[email protected]
Contact person for public queries
Name 105431 0
Christopher Partyka
Address 105431 0
Emergency Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 105431 0
Australia
Phone 105431 0
+612 8738 3950
Fax 105431 0
Email 105431 0
[email protected]
Contact person for scientific queries
Name 105432 0
Christopher Partyka
Address 105432 0
Emergency Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 105432 0
Australia
Phone 105432 0
+612 8738 3950
Fax 105432 0
Email 105432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant de-identified data as per the data collection form below
When will data be available (start and end dates)?
Upon study completion, estimated 1/3/2022; available for 5 years after publication.
Available to whom?
Clinical researchers with clear clinical study plan, ethical approval, pending review by the SABRE Study Steering Committee.
Available for what types of analyses?
Meta-analyses.
Others, depending on submission details.
How or where can data be obtained?
By direct email request to the Principle Investigator (via [email protected] )


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.