Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001612101
Ethics application status
Approved
Date submitted
25/10/2019
Date registered
22/11/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of paravertebral space and erector spinae plane regional anaesthesia techniques for patients with rib fractures – a randomised controlled trial
Scientific title
Effectiveness of paravertebral space and erector spinae plane regional anaesthesia techniques for patients with rib fractures – a randomised controlled trial
Secondary ID [1] 299650 0
None
Universal Trial Number (UTN)
U1111-1242-5812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 314982 0
Pain 314983 0
pulmonary function 315211 0
Condition category
Condition code
Anaesthesiology 313317 313317 0 0
Pain management
Anaesthesiology 313319 313319 0 0
Anaesthetics
Injuries and Accidents 313528 313528 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After consent, this pragmatic trial will randomise equal cohorts of patients with unilateral, image proven, blunt force (traumatic) rib fractures to receive one of two forms of regional anaesthesia.

The two arms are:
- Paravertebral block, and,
- Erector spinae plane block.

Both of these blocks involve the injection of local anaesthetics around the nerves of the back. The local anaesthetic in a paravertebral block is injected into the paravertebral space, and the local anaesthetic for the erector spinae plane block is injected between the muscles of the participants back.

The block will be preformed by either and anaesthetic consultant or anaesthetic registrar at the John Hunter Hospital, NSW, Australia. ANZCA required monitoring and sterility will be performed for all blocks. Both arms will receive 0.3ml/kg 0.375% ropivacaine (maximum of 20mls), followed by 20mls of 0.2% ropivacaine every four hours via intermittent programmed bolus.
Intervention code [1] 315905 0
Treatment: Other
Comparator / control treatment
The two arms are:
- Paravertebral block (active control), and,
- Erector spinae plane block (comparator)
Control group
Active

Outcomes
Primary outcome [1] 321798 0
Change in 100mm visual analogue scale (VAS) for pain
Timepoint [1] 321798 0
The primary timepoints are immediately pre-block, and 24 hours post block.
Secondary outcome [1] 376239 0
Opioid consumption during admission. This data will be taken from the patient controlled anaesthesia pump data log.
Timepoint [1] 376239 0
0 hours (immediately pre-block), 24, 48 and 72 hours post block.
Secondary outcome [2] 376240 0
Pulmonary function via spirometry
Timepoint [2] 376240 0
pre-intervention, 2, 24, 48, 72hours post block,
Secondary outcome [3] 376241 0
4. Complications and harms (during admission)
a. Pneumonia
b. Admission to ICU
c. SpO2, inspired oxygen and respiratory support
d. Clinical reviews and rapid responses
e. Block specific complications including pneumothorax, toxicity, infection, dislodgement and failure
Points A-D will be taken from the patient's records, and the patient will be reviewed daily by the research team.
Point E will be collected at a variety of times, namely during the block and immediately afterwards in the recovery ward from the anaesthetic block record, and from the medical notes in the subsequent days when reviewed by the research team and the Acute Pain Service.
Timepoint [3] 376241 0
72 hours post block
Secondary outcome [4] 376242 0
Sensory blockade distribution. This will be determined using a block to temperature (an ice-pack). The research team will compare the loss of cold sensation to a standardised dermatome chart.
Timepoint [4] 376242 0
1hour post block

Eligibility
Key inclusion criteria
- Age > 18 years
- Admitted
- Minimal other distracting injuries
- Unilateral, traumatic rib fractures – diagnosed radiologically via CXR or CT
- Pain requiring opioid analgesia
- Physical and cogitative ability to consent and attempt spirometry, i.e. able to obey simple commands
- Injury must be within 48hours from time to block
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pathological rib fractures (resulting from a non-traumatic – e.g. neoplastic – process)
- Condition preventing positioning for ESB or PVB e.g. unstable spinal fracture
- Distracting injuries or significantly impaired cognition e.g. multi-trauma, significant head injury
o We are defining a distracting painful injury as ‘any injury producing acute functional impairment, or, any injury as if it is thought to have the potential to impair the patients ability to appreciate other injuries’ as used in NEXUS study
- Coagulopathy or anticoagulated patients, in line with NYSORA guidelines
- Infection over ideal approach for block
- Any other contraindication for PVB or ESP
- Presence of a sternal fracture
- Rib fractures greater than 6 levels apart (e.g. 3 and 8 ok, 3 and 9 not ok).
- Renal failure – eGFR < /= 30

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)
Opaque, sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online random binary number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2019
Actual
Date of last participant enrolment
Anticipated
2/11/2020
Actual
Date of last data collection
Anticipated
9/11/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15050 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 28340 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 304125 0
Hospital
Name [1] 304125 0
John Hunter Hospital
Country [1] 304125 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle, Callaghan Campus, NSW, 2300
Country
Australia
Secondary sponsor category [1] 304343 0
Hospital
Name [1] 304343 0
John Hunter Hospital
Address [1] 304343 0
John Hunter Hospital, Lookout Rd, Lambton Heights, NSW, Australia 2300
Country [1] 304343 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304608 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304608 0
Ethics committee country [1] 304608 0
Australia
Date submitted for ethics approval [1] 304608 0
22/08/2019
Approval date [1] 304608 0
03/09/2019
Ethics approval number [1] 304608 0
2019/ETH09833

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

Contacts
Principal investigator
Name 97566 0
Dr Simon Ellis
Address 97566 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW Australia 2300
Country 97566 0
Australia
Phone 97566 0
+61404100225
Fax 97566 0
Email 97566 0
[email protected]
Contact person for public queries
Name 97567 0
Simon Ellis
Address 97567 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW Australia 2300
Country 97567 0
Australia
Phone 97567 0
+61404100225
Fax 97567 0
Email 97567 0
[email protected]
Contact person for scientific queries
Name 97568 0
Simon Ellis
Address 97568 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW Australia 2300
Country 97568 0
Australia
Phone 97568 0
+61404100225
Fax 97568 0
Email 97568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.