Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000688886
Ethics application status
Approved
Date submitted
24/06/2012
Date registered
27/06/2012
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of quality of recovery in ambulatory surgical patients receiving general anaesthesia versus regional anaesthesia
Scientific title
A randomised trial of quality of recovery in ambulatory adult surgical patients receiving general anaesthesia versus general anaesthesia supplemented with regional anaesthesia
Secondary ID [1] 280729 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of recovery in ambulatory adult surgical patients 286776 0
Condition category
Condition code
Anaesthesiology 287085 287085 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ambulatory adult patients undergoing upper limb surgery receives general anaesthesia alone, or general anaesthesia with regional block (brachial plexus block).
The PQRS (Postoperative Quality of Recovery Scale) tool is used for multiple domain characterisation of quality of recovery for both groups. Baseline data is obtained pre-operatively, in the Post-Anaesthesia Care Unit (PACU), and post-discharge
Intervention code [1] 285153 0
Not applicable
Comparator / control treatment
Baseline PQRS scores from each patient, prior to any anaesthetic intervention, forms the control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287408 0
Primary outcome is cognitive recovery based on PQRS criteria, defined as recovery back to baseline or better, expressed as % of baseline categorical values.
Timepoint [1] 287408 0
Day 3 post-operative
Secondary outcome [1] 298087 0
Secondary outcomes is recovery in Activities of Daily Living (ADLs) domain, expressed as % of baseline value.
Timepoint [1] 298087 0
Day 3 post-operative
Secondary outcome [2] 298114 0
Secondary outcomes is recovery in physiological domain, expressed as % of baseline value.
Timepoint [2] 298114 0
Day 3 post-operative
Secondary outcome [3] 298115 0
Secondary outcomes is recovery in nociceptive domain, expressed as % of baseline value.
Timepoint [3] 298115 0
Day 3 post-operative
Secondary outcome [4] 298116 0
Secondary outcomes is recovery in emotive domain, expressed as % of baseline value.
Timepoint [4] 298116 0
Day 3 post-operative
Secondary outcome [5] 298117 0
Secondary outcome is recovery in self assessment of function domain, expressed as % of baseline value.
Timepoint [5] 298117 0
Day 3 post-operative

Eligibility
Key inclusion criteria
adult ambulatory upper limb surgery lasting 1-3hours duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to provide informed written consent.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2013
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
1/09/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285514 0
Self funded/Unfunded
Name [1] 285514 0
Country [1] 285514 0
Primary sponsor type
Hospital
Name
Liverpool Hospital - South West Sydney Local Health District
Address
Elizabeth St
Liverpool
NSW 2150
Country
Australia
Secondary sponsor category [1] 284354 0
None
Name [1] 284354 0
Address [1] 284354 0
Country [1] 284354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287528 0
South West Sydney HREC
Ethics committee address [1] 287528 0
Level 1
Department of Anaesthesia
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Ethics committee country [1] 287528 0
Australia
Date submitted for ethics approval [1] 287528 0
01/08/2012
Approval date [1] 287528 0
17/09/2012
Ethics approval number [1] 287528 0

Summary
Brief summary
Ambulatory surgery is performed as an outpatient day-only procedure, and is considered minor surgery. Anaesthesia for this type of surgery can be with general anaesthesia (GA) only, or GA in combination with regional anaesthesia (RA).
However, while it is assumed that outpatient surgery constitutes minor surgical stress, there are sufficient case series observing severe cognitive dysfunction and poorer than expected functional recovery even after brief surgery. Anaesthetists have used RA techniques on the assumption that an effective nerve block allows a reduction in GA doses, better and prolonged analgesia, and a positive influence on post-operative recovery. This study will help anaesthetists determine if anaesthetic choices will lead to better outcomes for their patients undergoing minor ambulatory surgery.
The primary endpoint of this study is the incidence of cognitive recovery at day 3 between groups. Secondary endpoints will be recovery in other domains, over time.
Trial website
Trial related presentations / publications
submitted to journal for peer review
Public notes

Contacts
Principal investigator
Name 34359 0
Dr Alwin Chuan
Address 34359 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 34359 0
Australia
Phone 34359 0
+61 407 743 668
Fax 34359 0
Email 34359 0
[email protected]
Contact person for public queries
Name 17606 0
Dr Dr Alwin Chuan
Address 17606 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 17606 0
Australia
Phone 17606 0
+61407743668
Fax 17606 0
Email 17606 0
[email protected]
Contact person for scientific queries
Name 8534 0
Dr Dr Alwin Chuan
Address 8534 0
Department of Anaesthesia
Level 1
New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool NSW 2170
Country 8534 0
Australia
Phone 8534 0
+61407743668
Fax 8534 0
Email 8534 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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