ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001064190

Ethics application status

Approved

Date submitted

18/01/2019

Date registered

31/07/2019

Date last updated

31/07/2019

Date data sharing statement initially provided

31/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Efficacy of Regional Anaesthesia in a Dedicated Service: A Retrospective Comparison of Supervised Trainees and Consultant Anaesthetists

Scientific title

Efficacy of Regional Anaesthesia in a Dedicated Service: A Retrospective Comparison of Supervised Trainees and Consultant Anaesthetists

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1227-0092

Trial acronym

RAPTOR

Linked study record

Health condition

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

Acute pain

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Regional anaesthesia procedure undertaken by either supervised trainee or consultant anaesthetist. Data recorded in post-anaesthesia care unit by recovery nurse: Numeric rating scale pain score, administration of opioid or antiemetic also documented. This data was entered at time of patient care (17 Feb 2015 - 1 Aug 2018). Audit database then to be accessed for study.

Intervention code [1]

Not applicable

Comparator / control treatment

Regional anaesthesia procedure undertaken by either supervised trainee (comparator) or consultant (control) anaesthetist

Control group

Active

Outcomes

Primary outcome [1]

Significant post procedural pain (NRS >5) in post-anaesthesia care unit. This is assessed by recovery staff - verbally reported by patient and recorded in patient record. This data point is then transferred to an existing audit database which is the data source for this study.

Timepoint [1]

Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period

Secondary outcome [1]

Maximum pain score (NRS) in post anaesthesia care unit. This is assessed by recovery staff - verbally reported by patient and recorded in patient record. This data point is then transferred to an existing audit database which is the data source for this study.

Timepoint [1]

Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period

Secondary outcome [2]

Absence of pain (NRS = 0) in post-anaesthesia care unit. This is assessed by recovery staff - verbally reported by patient and recorded in patient record. This data point is then transferred to an existing audit database which is the data source for this study.

Timepoint [2]

Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period

Secondary outcome [3]

Requirement for systemic opioid in post-anaesthesia care unit. This is assessed by recovery staff according to routine practice and recorded in patient record. This data point is then transferred to an existing audit database which is the data source for this study.

Timepoint [3]

Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period

Secondary outcome [4]

Requirement for antiemetic in post-anaesthesia care unit. This is assessed by recovery staff according to routine practice and recorded in patient record. This data point is then transferred to an existing audit database which is the data source for this study.

Timepoint [4]

Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period

Eligibility

Key inclusion criteria

All patients entered in to regional anaesthesia audit database at the Royal Brisbane & Women's Hospital

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Patients not receiving regional anaesthesia procedures (e.g. vascular access or epidural blood patch).
Patients who did not go to the Post-Anaesthesia Care Unit (PACU) (for example, patients who were cared for in the intensive care unit) – and thus did not have a pain score recorded.
Patients receiving a regional anaesthesia procedure from both a consultant anaesthetist and a supervised trainee.
Patients receiving multiple regional anaesthesia procedures on more than one anatomical region (i.e. lower limb, upper limb, trunk, neuraxial/paravertebral)
Postoperative or “rescue” regional anaesthesia procedures.
Patients where it is unclear who performed the procedure.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Retrospective

Statistical methods / analysis

An estimated 1800 entries are in the 'Green Room' audit database. No estimates (published or using in-house data) of the proportion of consultant or registrar procedures resulting in an NRS >5 in PACU (primary outcome) are available to our knowledge. If we choose a conservative proportion for consultant procedures with an NRS>5 as 0.50, to have greater than 90% power to detect a clinically significant meaningful difference of 0.10, a minimum sample size of 1253 would be required. This is based on a type I error of 0.05 and a ratio of consultant procedures to registrars of 2.5:1.
The set sample size from the Green room database is thus sufficient to address the primary hypothesis.

Statistical Analysis
Summary statistics of variables will be reported. Chi-square for categorical outcomes and Mann-Whitney U-tests for continuous outcomes will test for differences in outcomes between consultants and registrars. P-values < 0.05 will be defined as statistically significant.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

5/08/2019

Actual

Date of last participant enrolment

Anticipated

5/08/2019

Actual

Date of last data collection

Anticipated

5/08/2019

Actual

Sample size

Target

1800

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Dr Adrian Chin, Royal Brisbane and Women's Hospital

Address [1]

Royal Brisbane & Women's Hospital,
Corner of Butterfield St and Bowen Bridge Road
Herston, QLD, Australia 4029

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Adrian Chin

Address

Royal Brisbane & Women's Hospital,
Corner of Butterfield St and Bowen Bridge Road
Herston, QLD, Australia 4029

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane & Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

Royal Brisbane & Women's Hospital
Executive Suites Lower Ground Floor
Dr James Mayne Building
Butterfield St, Herston, QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2018

Approval date [1]

20/12/2018

Ethics approval number [1]

LNR/2018/QRBW/47004

Summary

Brief summary

Training junior clinicians requires appropriate case selection and supervision. Thus, randomising patients to be exposed to trainees is problematic. We designed a retrospective observational study examining prospectively collected data. 
Data will be retrieved from an ongoing audit database of every regional anaesthesia procedure performed by the dedicated regional anaesthesia service of our hospital. This service performs regional anaesthesia using a block room or block team model. The principal proceduralist was recorded immediately after performance of the block as either a consultant or registrar.

The study group includes all patients who received care from supervised trainees. The comparator group included patients who received regional anaesthesia care from consultant anaesthestists.

Null hypothesis: There is no difference in the effectiveness of regional anaesthesia (defined as inadequate analgesia [NRS >5] in PACU) when supervised trainees are the principal proceduralist, when compared with consultants.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Daniel Foster

Address

Department of Anaesthesia & Perioperative Medicine
Level 4 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

Email

daniel.foster@healht.qld.gov.au

Contact person for public queries

Name

Daniel Foster

Address

Department of Anaesthesia & Perioperative Medicine
Level 4 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

Email

daniel.foster@healht.qld.gov.au

Contact person for scientific queries

Name

Daniel Foster

Address

Department of Anaesthesia & Perioperative Medicine
Level 4 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Rd
Herston QLD 4029

Country

Australia

Phone

+61 7 3646 8111

Fax

Email

daniel.foster@healht.qld.gov.au

Data sharing statement

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

No

No/undecided IPD sharing reason/comment

Database of over 2000 entries - not practical

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1105	Study protocol					376775-(Uploaded-18-01-2019-13-00-47)-Study-related document.doc

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.