ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

chest trauma

Condition category

Condition code

Injuries and Accidents

Fractures

Anaesthesiology

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]

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]

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]

24 hours after catheter insertion and commencement of local anaesthesia infusion

Primary outcome [2]

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]

48 hours after catheter insertion and commencement of local anaesthesia infusion

Primary outcome [3]

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]

72 hours after catheter insertion and commencement of local anaesthesia infusion

Secondary outcome [1]

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]

24 hours after catheter insertion and commencement of local anaesthesia infusion

Secondary outcome [2]

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]

48 hours after catheter insertion and commencement of local anaesthesia infusion

Secondary outcome [3]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Anaesthesia, Liverpool Hospital

Address [1]

Room 124
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South West Sydney Local Health District HREC

Ethics committee address [1]

Research Directorate 
Locked Bag 7279
Eastern Campus
Liverpool BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/12/2020

Ethics approval number [1]

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

A/Prof Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170

Country

Australia

Phone

+61 2 87388582

Fax

alwin.chuan@health.nsw.gov.au

Contact person for public queries

Name

Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170

Country

Australia

Phone

+61 2 87388582

Fax

alwin.chuan@health.nsw.gov.au

Contact person for scientific queries

Name

Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1
New Clinical Building
Liverpool Hospital
Elizabeth St, Liverpool
NSW 2170

Country

Australia

Phone

+61 2 87388582

Fax

alwin.chuan@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

not permitted with ethics

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10329	Ethical approval	alwin.chuan@health.nsw.gov.au			contact corresponding author

Results publications and other study-related documents

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No additional documents have been identified.

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