Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000659404
Ethics application status
Approved
Date submitted
2/06/2025
Date registered
23/06/2025
Date last updated
23/06/2025
Date data sharing statement initially provided
23/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving outcomes for patients with blunt chest injuries by Boosting Regional Anaesthesia and Virtual Enhanced Chest Injury Pathway
Scientific title
Improving outcomes for patients with blunt chest injuries by Boosting Regional Anaesthesia and Virtual Enhanced Chest Injury Pathway – a pilot clinical trial
Secondary ID [1] 314608 0
None.
Universal Trial Number (UTN)
Trial acronym
BRAVE-CHIP-Pi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 337680 0
Thoracic trauma 337681 0
Condition category
Condition code
Public Health 334072 334072 0 0
Health service research
Injuries and Accidents 334071 334071 0 0
Fractures
Emergency medicine 334015 334015 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is the “BRAVE-CHIP” model of care.

This model identifies suitable patients with rib fractures and is designed to accelerate their safe transfer into virtual healthcare by using a care bundle that includes the prescription of oral analgesia, prompt use of regional anaesthesia (serratus anterior plane block) and early referral to virtual care involving a multidisciplinary team of nursing, medical and physiotherapy. The model involves each of these components together, and is being assessed in summation.

All patients enrolled into this arm will receive:
1. regular paracetamol (oral 1g, 4 times per day) and celecoxib (oral 200mg, once daily)
2. regular and breakthrough oxycodone (oral 5-10mg, 4 times per day, plus 5mg every 2-4 hours as required)
3. a serratus anterior plane block, administered by either Emergency Medicine or Trauma physicians as a single-shot (once only) injection [30-40mL of 0.75% solution]
4. Virtual clinical care commencing the day after hospital discharge (including daily medical, nursing and allied health review with a focus on pain management and respiratory function). It is estimated that patients will receive a minimum of 3 (up to 5) virtual follow-up, which will last for 30-60 minutes in duration.

*Medication adherence will be reviewed through direct patient interview during Virtual Care assessment. This will be recorded in the clinical record and transcribed into the trial database.
*Virtual pain management will be an assessment of pain scores, review of recent analgesic drug use and advice by the clinicians on how to optimise these medications for better pain control.
*Virtual respiratory function assessment will include a review of oxygenation via pulse oximetry (provided to them at the time of hospital discharge) and engagement with physiotherapy through breathing exercise and capacity to both deep breathe & cough.
Intervention code [1] 331200 0
Treatment: Other
Comparator / control treatment
Standard care: "Chest injury pathway” (CHIP).

This is the current standard of care for treating patients with rib fractures. It is a care bundle or set of therapies which provides early pain medicine designed to reduce pain, and the breathing complications associated with rib fractures. This typically involves standardised pain medicine usually including the prescription of a ‘pain button’ called Patient Controlled Analgesia (PCA) as well as nursing and physiotherapy regimes. Some of these patients receive regional anaesthesia (e.g. a serratus anterior plane block) to help with their pain management. Patients in this pathway are admitted to hospital for several (3-6) days to receive their treatment. They will be monitored closely during this time by trauma doctors, nursing staff and physiotherapists.
Control group
Active

Outcomes
Primary outcome [1] 341674 0
Proportion of patients transferred home within 48 hours
Timepoint [1] 341674 0
48 hours from hospital arrival.
Secondary outcome [1] 448297 0
Hospital length of stay
Timepoint [1] 448297 0
30-days post first admission to hospital.
Secondary outcome [2] 448300 0
Cumulative opioid requirements
Timepoint [2] 448300 0
24 hours post-hospital arrival
Secondary outcome [3] 448298 0
Pain score
Timepoint [3] 448298 0
24-hours post hospital arrival
Secondary outcome [4] 448294 0
Representation to hospital
Timepoint [4] 448294 0
Within 48-hours of hospital discharge (home or transfer to virtual care)
Secondary outcome [5] 448296 0
Proportion of patients transferred home within 24 hours of hospital arrival (by end of study)
Timepoint [5] 448296 0
Within 24 hours of hospital arrival
Secondary outcome [6] 448301 0
Cumulative opioid requirements
Timepoint [6] 448301 0
48 hours post-hospital arrival
Secondary outcome [7] 448299 0
Pain score
Timepoint [7] 448299 0
One-week post hospital arrival
Secondary outcome [8] 448302 0
Cumulative opioid requirements
Timepoint [8] 448302 0
72 hours post-hospital arrival
Secondary outcome [9] 448295 0
Hospital re-admission for symptoms/complications (eg. severe pain, breathlessness, fever) arising from their thoracic injury.
Timepoint [9] 448295 0
Within one week of hospital arrival.
Secondary outcome [10] 448303 0
Respiratory deterioration (eg. a new pneumonia or oxygen requirement)
Timepoint [10] 448303 0
One week post-hospital arrival.
Secondary outcome [11] 448305 0
Quality of life assessment
Timepoint [11] 448305 0
30-days post-hospital arrival.
Secondary outcome [12] 448304 0
Chronic pain assessment
Timepoint [12] 448304 0
30-days post-hospital arrival.

Eligibility
Key inclusion criteria
Age 18-75 years
RibScore equal to zero.
Normal vital signs
Ability to undertake video conferencing (including with assistance)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other injuries requiring hospital admission &/or operative management
Major skeletal injury (femur, spinal or pelvic fracture)
Other medical indications for hospital admission (e.g. syncope/monitoring)
Age greater than or equal to 65 with FRAIL scale score greater than or equal to 3
Chronic respiratory illness (e.g. COPD, bronchiectasis)
Use of home oxygen (including oxygen concentrators)
Pre-injury daily opioid use
Pregnant women
Prisoners

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)
In-built randomisation schedule generated within REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur in blocks of various sizes (2,4,6).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
6/07/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27994 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 44192 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 319125 0
Government body
Name [1] 319125 0
Royal North Shore Campus Research Grant 2024 (via Northern Sydney Local Health District)
Country [1] 319125 0
Australia
Primary sponsor type
Government body
Name
NSLHD
Address
Country
Australia
Secondary sponsor category [1] 321587 0
None
Name [1] 321587 0
Address [1] 321587 0
Country [1] 321587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317718 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 317718 0
Ethics committee country [1] 317718 0
Australia
Date submitted for ethics approval [1] 317718 0
05/05/2025
Approval date [1] 317718 0
21/05/2025
Ethics approval number [1] 317718 0
2025/ETH00594

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

Contacts
Principal investigator
Name 141922 0
Dr Christopher Partyka
Address 141922 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065, Australia
Country 141922 0
Australia
Phone 141922 0
+61 2 94632227
Fax 141922 0
Email 141922 0
[email protected]
Contact person for public queries
Name 141923 0
Christopher Partyka
Address 141923 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065, Australia
Country 141923 0
Australia
Phone 141923 0
+61 2 94632227
Fax 141923 0
Email 141923 0
[email protected]
Contact person for scientific queries
Name 141924 0
Christopher Partyka
Address 141924 0
Royal North Shore Hospital, Reserve Road, St Leonards, NSW 2065, Australia
Country 141924 0
Australia
Phone 141924 0
+61 2 94632227
Fax 141924 0
Email 141924 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not during the pilot phase of this study.



What supporting documents are/will be available?

No Supporting Document Provided


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.