Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000356167
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
6/03/2019
Date last updated
7/07/2021
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing the effect of two types of continuous nerve block on pain experienced by patients with multiple rib fractures.
Scientific title
A Pilot, Randomised Controlled Trial Comparing the effect of Continuous Thoracic Paravertebral Block and Continuous Thoracic Erector Spinae Block on pain relief in Patients with Unilateral Multiple Rib Fractures.
Secondary ID [1] 297565 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rib fractures 311812 0
Condition category
Condition code
Anaesthesiology 310419 310419 0 0
Pain management
Injuries and Accidents 310452 310452 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of two interventions in patients with unilateral multiple rib fractures.
Arm 1 - Provision of continuous thoracic paravertebral block.
Arm 2 - Provision of continuous thoracic erector spinae block.

Multiple rib fractures are a common injury found in the trauma patient. The thoracic paravertebral has become the gold standard for analgesia in patients with unilateral multiple rib fractures. The erector spinae block is a novel technique that has emerged as an alternative intervention and has gained popularity due to its relative ease and lower risk profile.

Patients will be provided with a Patient Informed Consent Form to read and this will be discussed with the patient by a member of the research team. Patients can also withdraw consent at any time and will be provided with a Participant Withdrawal Form.

An 18G epidural catheter kit will be utilised for performing these nerve blocks. For both interventions, once the space is accessed, an initial bolus of 20ml 0.5% Ropivacaine will be administered before a catheter is placed into the space and secured to the patients back. The continuous thoracic paravertebral block will then continue with a programmed intermittent bolus of 10ml/hr of 0.2% Ropivacaine. The continuous erector spinae block will continue with a programmed intermittent bolus of 20ml of 0.2% Ropivacaine every 2hrs. Patients will be provided with a Fentanyl PCA post procedure.

Both interventions will be performed by Specialist Anaesthetists trained in the provision of regional anaesthesia. The nerve blocks will be performed in the theatre complex under ultrasound-guidance using sterile conditions as is our practice. Standard ANZCA monitoring will be attached and patients will be returned to the ward after a period of observation to ensure safety.

Patients will be seen by the Acute Pain Service and their pain scores will be ascertained at 24hrs at rest and with coughing. The catheters will be left in place until the patient is deemed suitable for a transition to oral medications.
Intervention code [1] 313800 0
Treatment: Drugs
Comparator / control treatment
Arm 1 - Provision of continuous thoracic paravertebral block. (comparator)
Arm 2 - Provision of continuous thoracic erector spinae block.
Control group
Active

Outcomes
Primary outcome [1] 319288 0
Pain scores (Numerical Rating Scale) at rest.
Timepoint [1] 319288 0
Baseline prior to intervention and then 24hrs, 48hrs, and 72hrs post intervention.
Primary outcome [2] 319320 0
Pain scores (Numerical Rating Scale) with coughing.
Timepoint [2] 319320 0
Baseline prior to intervention and then 24hrs, 48hrs, and 72hrs post intervention.
Secondary outcome [1] 367575 0
Opioid consumption - calculation of oral morphine equivalents used by patients from data-linkage to electronic medical records and audit of PCA machine analytics used by patients from the completion of the regional procedure at the following time points.
Timepoint [1] 367575 0
Baseline prior to intervention and then 24hrs, 48hrs and 72hrs post intervention.
Secondary outcome [2] 367576 0
Pneumonia - assessed by data-linkage to electronic medical records.
Timepoint [2] 367576 0
Prior to hospital discharge
Secondary outcome [3] 367577 0
Intensive Care Admission - assessed by data-linkage to electronic medical records.
Timepoint [3] 367577 0
Prior to hospital discharge
Secondary outcome [4] 367578 0
Requirement for mechanical ventilation - assessed by data-linkage to electronic medical records.
Timepoint [4] 367578 0
Prior to hospital discharge
Secondary outcome [5] 367739 0
Respiratory rate - assessed by data-linkage to electronic medical records.
Timepoint [5] 367739 0
Baseline prior to intervention and then 24hrs, 48hrs, and 72hrs post intervention.
Secondary outcome [6] 367740 0
Incentive spirometry volume assessed by data linkage to electronic medical records.
Timepoint [6] 367740 0
Baseline prior to intervention and then 24hrs, 48hrs and 72hrs post intervention.
Secondary outcome [7] 367741 0
Hospital length of stay assessed by data-linkage to electronic medical records.
Timepoint [7] 367741 0
At discharge.
Secondary outcome [8] 367742 0
Patient rated outcome (Quality of Recovery Score).
Timepoint [8] 367742 0
Baseline prior to intervention and then 24hrs, 48hrs and 72hrs post intervention.

Eligibility
Key inclusion criteria
Patients with unilateral multiple rib fractures who have been referred to the Acute Pain Management service and are deemed appropriate for a regional anaesthetic technique.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent or understand english.
Contraindications for regional anaesthesia including anticoagulation or local anaesthetic allergy.
Local infection or trauma at the site of injection.
Existing chronic pain disorders.
Severe renal or hepatic disease.
Significant spinal injury.
The need for more than one regional catheter.
Significant concomitant painful injuries.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/03/2020
Actual
26/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13279 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 25845 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 302117 0
Hospital
Name [1] 302117 0
Gold Coast University Hospital
Country [1] 302117 0
Australia
Primary sponsor type
Individual
Name
Dr Lucas Edwards
Address
Gold Coast University Hospital
1 Hospital Blvd,
Southport,
Gold Coast,
Qld. 4215.
Country
Australia
Secondary sponsor category [1] 301950 0
Individual
Name [1] 301950 0
Dr Craig Daniel
Address [1] 301950 0
Gold Coast University Hospital 1 Hospital Blvd, Southport, Gold Coast, Qld. 4215.
Country [1] 301950 0
Australia
Secondary sponsor category [2] 301952 0
Individual
Name [2] 301952 0
Dr David Liu
Address [2] 301952 0
Gold Coast University Hospital 1 Hospital Blvd, Southport, Gold Coast, Qld. 4215.
Country [2] 301952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302798 0
Gold Coast Hospital and Health Service Human Research Ethics Committee (EC00160)
Ethics committee address [1] 302798 0
Ethics committee country [1] 302798 0
Australia
Date submitted for ethics approval [1] 302798 0
18/03/2019
Approval date [1] 302798 0
13/08/2019
Ethics approval number [1] 302798 0
HREC/2019/QGC/51582

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

Contacts
Principal investigator
Name 91434 0
Dr Lucas Edwards
Address 91434 0
Gold Coast University Hospital 1 Hospital Blvd, Southport, Gold Coast, Qld. 4215.
Country 91434 0
Australia
Phone 91434 0
+61 0437431503
Fax 91434 0
Email 91434 0
[email protected]
Contact person for public queries
Name 91435 0
Lucas Edwards
Address 91435 0
Gold Coast University Hospital 1 Hospital Blvd, Southport, Gold Coast, Qld. 4215.
Country 91435 0
Australia
Phone 91435 0
+61 0437431503
Fax 91435 0
Email 91435 0
[email protected]
Contact person for scientific queries
Name 91436 0
Lucas Edwards
Address 91436 0
Gold Coast University Hospital 1 Hospital Blvd, Southport, Gold Coast, Qld. 4215.
Country 91436 0
Australia
Phone 91436 0
+61 0437431503
Fax 91436 0
Email 91436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• All of the individual participant data collected during the trial, after de-identification

What types of analyses could be done with individual participant data?
• Any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator

Are there extra considerations when requesting access to individual participant data?
No


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.