Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000304831
Ethics application status
Approved
Date submitted
23/01/2021
Date registered
18/03/2021
Date last updated
28/02/2022
Date data sharing statement initially provided
18/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
In emergency admission patients admitted to Liverpool Hospital for chest trauma, what is effect of additional continuous catheter infusion analgesia techniques on reported pain compared to intravenous analgesia alone.
Scientific title
Effectiveness of continuous catheter analgesia on reported pain in chest trauma patients: A Quality Improvement Audit
Secondary ID [1] 303251 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest trauma 320430 0
Condition category
Condition code
Injuries and Accidents 318323 318323 0 0
Fractures
Anaesthesiology 318324 318324 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Previously, chest trauma patients received traditional analgesia through oral and intravenous routes only. Our institution has since introduced (2020) local anaesthesia catheter infusion techniques to improve the quality of pain relief, in addition to the traditional analgesia regimen. To therefore compare this historical patient group (control) against patients who also received a catheter infusion technique (intervention).

Continuous local anaesthesia (0.2% ropivacaine) infusions for chest trauma (rib and sternal fractures), inserted into the following anatomical locations: thoracic epidural, paravertebral, erector spinae, and pectoserratus fascial planes. Duration and dosage of infusion is titrated to pain relief as directed by the acute pain service; duration may be 1-10 days and continuous dosing at 5-15ml/hr via the catheter. Location of catheter insertion is dependent on location of trauma, and clinically decided by the acute pain service. Above data points for location, duration, dosage, are collated from the acute pain service database, which is prospectively recorded daily.
Intervention code [1] 319555 0
Treatment: Drugs
Comparator / control treatment
oral and intravenous analgesia pain management as per local hospital protocol, including rapid release and slow release opioids, non-steroidal anti-inflammatory drugs, paracetamol, pregabalin, and ketamine. Retrospective search of the acute pain service database, from Jan 2019- March 2020.
Control group
Historical

Outcomes
Primary outcome [1] 326294 0
Rate of change in rest numerical rating scale of pain (11 item, scored 0-10 pain intensity) from pre-intervention to 24 hours after intervention
Timepoint [1] 326294 0
24 hours after catheter insertion and commencement of local anaesthesia infusion
Primary outcome [2] 326295 0
Rate of change in rest numerical rating scale of pain (11 item, scored 0-10 pain intensity) from 24 hours to 48 hours after intervention
Timepoint [2] 326295 0
48 hours after catheter insertion and commencement of local anaesthesia infusion
Primary outcome [3] 326296 0
Rate of change in rest numerical rating scale of pain (11 item, scored 0-10 pain intensity) from 48 hours to 72 hours after intervention
Timepoint [3] 326296 0
72 hours after catheter insertion and commencement of local anaesthesia infusion
Secondary outcome [1] 390943 0
Rate of change in movement numerical rating scale of pain (11 item, scored 0-10 pain intensity) from pre-intervention to 24 hours after intervention
Timepoint [1] 390943 0
24 hours after catheter insertion and commencement of local anaesthesia infusion
Secondary outcome [2] 390944 0
Rate of change in movement numerical rating scale of pain (11 item, scored 0-10 pain intensity) from 24 hours to 48 hours after intervention
Timepoint [2] 390944 0
48 hours after catheter insertion and commencement of local anaesthesia infusion
Secondary outcome [3] 390945 0
Rate of change in movement numerical rating scale of pain (11 item, scored 0-10 pain intensity) from 48 hours to 72 hours after intervention
Timepoint [3] 390945 0
72 hours after catheter insertion and commencement of local anaesthesia infusion

Eligibility
Key inclusion criteria
all adults (> 18yo) admitted to Liverpool Hospital under the trauma service, for chest trauma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no exclusions

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Before-and-after methodology; not blinded. Chest trauma patients who received traditional oral and intravenous analgesia only (historical cohort) will be compared against chest trauma patients who received oral and intravenous analgesia and also chest wall local anaesthesia catheter infusions (intervention).
Quality assurance study using the acute pain database (prospectively collected) for outcomes
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mann Whitney U test comparing rates of change in numerical pain scores between the before-and-after groups at 24, 48, and 72 hours

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
covid lockdown - dropped admissions compared to previous
Date of first participant enrolment
Anticipated
22/03/2021
Actual
22/03/2021
Date of last participant enrolment
Anticipated
Actual
30/03/2021
Date of last data collection
Anticipated
Actual
13/04/2021
Sample size
Target
120
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32820 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 307660 0
Hospital
Name [1] 307660 0
Department of Anaesthesia, Liverpool Hospital
Country [1] 307660 0
Australia
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871
Country
Australia
Secondary sponsor category [1] 308355 0
None
Name [1] 308355 0
Address [1] 308355 0
Country [1] 308355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307699 0
South West Sydney Local Health District HREC
Ethics committee address [1] 307699 0
Research Directorate
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871
Ethics committee country [1] 307699 0
Australia
Date submitted for ethics approval [1] 307699 0
Approval date [1] 307699 0
17/12/2020
Ethics approval number [1] 307699 0
LIV142/2020/49

Summary
Brief summary
Rib fractures account for a significant proportion of trauma presentations. Chest trauma alone is associated with significant morbidity and mortality; the mortality rate increases from 15% for 3-5 fractured ribs to 34% for 6 or more fractured ribs.

The accepted approach involves multi-modal pharmacological therapies incorporating simple analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. But drug therapy has multiple side effects and is often insufficient. As such, there is growing interest in regional techniques in the management of these patients, such as chest wall catheter infusions of local anaesthesia.

At Liverpool Hospital, referral to the Acute Pain Service to insert chest wall catheters was incorporated in the Rib Fracture Pathway for patient care in 2019. The implementation of chest wall catheter infusion techniques aims to reduce patient discomfort, reduce opioid requirement, reduce pulmonary complications and facilitate earlier discharge from ICU and hospital.

This is a before-and-after quality improvement/assurance audit of a cohort of patients treated with traditional oral and intravenous analgesics, and comparing to the cohort of patients treated with traditional analgesics as well as the catheter infusion techniques.

This is a retrospective study for both the control and interventional arms. We will collect pre-collected data on pain scores, analgesia requirements, ICU stay, length of stay, from Jan 2019 to March 2020.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108186 0
A/Prof Alwin Chuan
Address 108186 0
Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170
Country 108186 0
Australia
Phone 108186 0
+61 2 87388582
Fax 108186 0
Email 108186 0
[email protected]
Contact person for public queries
Name 108187 0
Alwin Chuan
Address 108187 0
Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170
Country 108187 0
Australia
Phone 108187 0
+61 2 87388582
Fax 108187 0
Email 108187 0
[email protected]
Contact person for scientific queries
Name 108188 0
Alwin Chuan
Address 108188 0
Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170
Country 108188 0
Australia
Phone 108188 0
+61 2 87388582
Fax 108188 0
Email 108188 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
not permitted with ethics


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10329Ethical approval[email protected]   contact corresponding author



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.