Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001786280p
Ethics application status
Not yet submitted
Date submitted
28/10/2018
Date registered
31/10/2018
Date last updated
31/10/2018
Date data sharing statement initially provided
31/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of two types of regional nerve block (erector spinae plane versus paravertebral) to treat the pain caused by rib fractures.
Scientific title
Erector spinae plane versus paravertebral regional anaesthesia techniques for rib fracture pain - a randomised and blinded RCT comparing efficacy and safety.
Secondary ID [1] 296446 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 310221 0
Condition category
Condition code
Injuries and Accidents 308953 308953 0 0
Fractures
Anaesthesiology 308954 308954 0 0
Pain management
Anaesthesiology 308955 308955 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will compare the safety and efficacy of two interventions in patients with rib fractures. Both interventions are regional anaesthetic techniques where a continuous infusion of local anaesthetic is delivered to nerves travelling to the ribs, however the catheter will be inserted into different locations.
Arm 1: Erector spinae plane
Arm 2: Paravertebral space
Both will have the same prescription for ongoing local anaesthetic delivery - 10ml/hr 0.2% ropivacaine. All interventions will be performed by consultant anaesthetists, or advanced trainees in anaesthesia who are competent at these types of blocks.

In order to enhance the fidelity of the interventions, the consultant anaesthetists performing the regional nerve blocks are a small group of select consultants who are highly skilled in this area. It is voluntary to allow their patients to be a part of this trial and all consultants taking part believe in the value of high quality research in this area. Wherever possible, the interventions will be supervised by a research team member, and all ongoing prescriptions will be reviewed to ensure they reflect the study protocol prescription in its entirety. Where it is not possible to supervise the intervention (e.g. weekends) it is common practise to record the procedure on the ultrasound machine, and this can be checked by a research team member.
Intervention code [1] 312771 0
Treatment: Other
Comparator / control treatment


Intervention - erector spinae blocks
Comparator - paravertebral blocks
Control group
Active

Outcomes
Primary outcome [1] 307918 0
Verbal pain score with 0 meaning no pain at all, and 10 described as the worst pain imaginable.
Timepoint [1] 307918 0
Immediately before and following intervention, and on each subsequent day for one week, or the length of hospital stay (whichever is shorter).
Primary outcome [2] 307919 0
Opioid dose used for each 24 hour period following the intervention as assessed by the total of :
1. Patient controlled analgesia device if applicable
2. Hospital medication chart
Timepoint [2] 307919 0
Each 24 hour period for one week, or length of hospital stay (whichever is shorter)
Primary outcome [3] 307920 0
Spirometry - VC
Timepoint [3] 307920 0
Immediately before and following intervention, and on each subsequent day for one week, or length of hospital stay (whichever is shorter).
Secondary outcome [1] 353351 0
Adverse effects / complication rate such as infections at the site, inadequate analgesia requiring replacement of the catheter, pneumothorax, epidural spread of local anaesthetic etc. These will be assessed and recorded daily by the acute pain management service on review of the patient and their medical chart.
Timepoint [1] 353351 0
Daily for one week or length of hospital stay, whichever is shorter
Secondary outcome [2] 353352 0
Length of hospital stay as assessed by hospital records
Timepoint [2] 353352 0
Length of hospital stay as assessed by hospital records
Secondary outcome [3] 353353 0
Patient satisfaction as rated on a 5 point scale with 0 = not at all satisfied and 5 = extremely satisfied.
Timepoint [3] 353353 0
Daily for one week or length of hospital stay, whichever is shorter

Eligibility
Key inclusion criteria
• Patients aged 18 to 85
• Isolated unilateral rib fractures with no significant other distracting injuries
• Greater than 3 rib fractures
• Patients who have been assessed by the Acute Pain Management Service and recommended for a regional analgesia catheter treatment (ESP or PVB Catheter)
• Patients able to communicate pain scores, request appropriate additional analgesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who are unable to communicate effectively due to poor English, dementia or brain injury
• Patients admitted to the intensive care unit for invasive ventilatory support
• Patients with significant other injuries
• Patients with pre-existing opiate dependence of greater than 30mg morphine equivalents per day
• Significant renal or hepatic dysfunction
• Known or suspected allergy to amide local anaesthetic agents
• Uncontrolled infection
• Significant coagulopathy

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2018
Actual
Date of last participant enrolment
Anticipated
1/12/2019
Actual
Date of last data collection
Anticipated
7/12/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12293 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 24485 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 301042 0
Hospital
Name [1] 301042 0
Royal Brisbane and Women's
Country [1] 301042 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street, Herston. QLD, 4029
Country
Australia
Secondary sponsor category [1] 300670 0
None
Name [1] 300670 0
Address [1] 300670 0
Country [1] 300670 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301797 0
Metro North Hospital and Health Service - The Prince Charles Hospital - Human Research Ethics Committee
Ethics committee address [1] 301797 0
Ethics committee country [1] 301797 0
Australia
Date submitted for ethics approval [1] 301797 0
02/11/2018
Approval date [1] 301797 0
Ethics approval number [1] 301797 0

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

Contacts
Principal investigator
Name 88138 0
Dr Tegan Burgess
Address 88138 0
Anaesthetics Department
Level 4 Ned Hanlon Building
RBWH
Butterfield Street
Herston QLD 4029
Country 88138 0
Australia
Phone 88138 0
+61 7 36468111
Fax 88138 0
Email 88138 0
tegan.burgess@uqconnect.edu.au
Contact person for public queries
Name 88139 0
Tegan Burgess
Address 88139 0
Anaesthetics Department
Level 4 Ned Hanlon Building
RBWH
Butterfield Street
Herston QLD 4029
Country 88139 0
Australia
Phone 88139 0
+61 7 36468111
Fax 88139 0
Email 88139 0
tegan.burgess@uqconnect.edu.au
Contact person for scientific queries
Name 88140 0
Tegan Burgess
Address 88140 0
Anaesthetics Department
Level 4 Ned Hanlon Building
RBWH
Butterfield Street
Herston QLD 4029
Country 88140 0
Australia
Phone 88140 0
+61 7 36468111
Fax 88140 0
Email 88140 0
tegan.burgess@uqconnect.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data from this trial will only be published when analysed as an intervention group. It is not meaningful to interpret single participant data.


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.