Trial Review

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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] 297132 0
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 311162 0
Condition category
Condition code
Anaesthesiology 309782 309782 0 0
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] 313396 0
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] 318739 0
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] 318739 0
Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period
Secondary outcome [1] 365866 0
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] 365866 0
Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period
Secondary outcome [2] 365867 0
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] 365867 0
Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period
Secondary outcome [3] 365868 0
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] 365868 0
Any time during stay documented in post-anaesthesia care unit record during immediate post-procedure period
Secondary outcome [4] 365869 0
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] 365869 0
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] 12960 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 25432 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 301693 0
Hospital
Name [1] 301693 0
Dr Adrian Chin, Royal Brisbane and Women's Hospital
Country [1] 301693 0
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] 301413 0
None
Name [1] 301413 0
Address [1] 301413 0
Country [1] 301413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302413 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 302413 0
Royal Brisbane & Women's Hospital
Executive Suites Lower Ground Floor
Dr James Mayne Building
Butterfield St, Herston, QLD 4029
Ethics committee country [1] 302413 0
Australia
Date submitted for ethics approval [1] 302413 0
07/12/2018
Approval date [1] 302413 0
20/12/2018
Ethics approval number [1] 302413 0
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 90158 0
Dr Daniel Foster
Address 90158 0
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 90158 0
Australia
Phone 90158 0
+61 7 3646 8111
Fax 90158 0
Email 90158 0
[email protected]
Contact person for public queries
Name 90159 0
Dr Daniel Foster
Address 90159 0
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 90159 0
Australia
Phone 90159 0
+61 7 3646 8111
Fax 90159 0
Email 90159 0
[email protected]
Contact person for scientific queries
Name 90160 0
Dr Daniel Foster
Address 90160 0
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 90160 0
Australia
Phone 90160 0
+61 7 3646 8111
Fax 90160 0
Email 90160 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
Database of over 2000 entries - not practical


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1105Study protocol    376775-(Uploaded-18-01-2019-13-00-47)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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