Trial Review

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
ACTRN12616000878471
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
5/07/2016
Date last updated
10/04/2019
Date data sharing statement initially provided
10/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the post-operative quality of recovery and chronic pain rates after elective shoulder surgery
Scientific title
Assessment of post-operative recovery and chronic pain outcomes after elective shoulder surgery
Secondary ID [1] 289571 0
none
Universal Trial Number (UTN)
U1111-1184-8064
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder surgery functional outcomes 299300 0
Condition category
Condition code
Musculoskeletal 299296 299296 0 0
Other muscular and skeletal disorders
Anaesthesiology 299374 299374 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Elective adult shoulder surgery patients will be recruited for a 2 year observational study on postoperative functional outcomes. Prior to surgery, patients will receive a baseline assessment of function using the following questionnaires: Postoperative Quality of Recovery Scale (PostopQRS), the modified Brief Pain Inventory scale (mBPI), Pain Catastrophizing Scale (PCS), the Constant Shoulder Score (CSS), and the Western Ontario Rotator Cuff (WORC) scale. These will assess the functional domains of recovery, pre-operative pain levels, susceptibility for chronic pain, and functional measures of shoulder movement and ability, respectively.
As a pragmatic study, there will be no change to anaesthesia, surgical, or nursing management of these patients.
Patients will be followed up at the following time periods using the following schedule:
Baseline - PostopQRS, mBPI, PCS, CSS, WORC
15 minutes after cessation of anaesthesia - PostopQRS
40 minutes after cessation of anaesthesia - PostopQRS
Day 1 postoperative - PostopQRS, mBPI
Day 3 postoperative - PostopQRS, mBPI
Month 3 postoperative - PostopQRS, mBPI, PCS, CSS, WORC
Year 1 postoperative - mBPI, PCS, CSS, WORC
Year 2 postoperative - mBPI, PCS, CSS, WORC
Intervention code [1] 295173 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298788 0
dichotomised cognitive recovery as defined with the PostopQRS questionnaire, defined as cognitive domain score greater than pre-operative baseline cognitive score
Timepoint [1] 298788 0
Day 3 postoperative
Secondary outcome [1] 325206 0
recovery in other domains (composite physiological, activities of daily living, emotional, pain, overall recovery) of the PostopQRS questionnaire
Timepoint [1] 325206 0
Day 1 postoperative
Secondary outcome [2] 325309 0
recovery in other domains (composite physiological, activities of daily living, emotional, pain, overall recovery) of the PostopQRS questionnaire
Timepoint [2] 325309 0
Day 3 postoperative
Secondary outcome [3] 325310 0
recovery in other domains (composite physiological, activities of daily living, emotional, pain, overall recovery) of the PostopQRS questionnaire
Timepoint [3] 325310 0
Month 3 postoperative
Secondary outcome [4] 325311 0
presence of chronic postsurgical pain (CPSP) as determined by a VAS score > 5 on mBPI
Timepoint [4] 325311 0
Month 3 postoperative
Secondary outcome [5] 325312 0
presence of chronic postsurgical pain (CPSP) as determined by a VAS score > 5 on mBPI
Timepoint [5] 325312 0
Year 1 postoperative
Secondary outcome [6] 325373 0
presence of chronic postsurgical pain (CPSP) as determined by a VAS score > 5 on mBPI
Timepoint [6] 325373 0
Year 2 postoperative

Eligibility
Key inclusion criteria
All adult (>18 yo) patients admitted for elective shoulder surgery at Kareena Private Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to consent or complete the questionnaires due to lack of English proficiency, pre-existing cognitive deficits, or intellectual disability.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Convenience sample size determined by numbers of anticipated elective shoulder surgery at Kareena Private Hospital over 2 years
Patient characteristics and intra-operative data will be analysed using independent samples t-test, Mann-Whitney U test, Fisher's exact test, and chi-square test as appropriate.
The primary outcome of proportion of patients recovered in each cohort will be analysed by Fisher's exact test. For analysis of secondary outcomes of recovery in the individual PostopQRS domains, the Cochran-Mantel-Haenszel test with continuity correction will be used to assess proportions of patients who recovered between groups, over all timepoints, stratified by age, duration of surgery, pain, and surgical pathology.
The secondary outcome of CPSP is determined by a VAS score > 5 on the mBPI at M3, Y1, and Y2 timepoints. To identify factors which contribute to CPSP, univariate analysis will be performed on pre-operative, intra-operative, and acute pain outcomes and CPSP. Factors which scored a p value < 0.02 will be entered into a multivariable logistic regression model.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2017
Actual
17/01/2017
Date of last participant enrolment
Anticipated
26/11/2019
Actual
Date of last data collection
Anticipated
30/11/2021
Actual
Sample size
Target
250
Accrual to date
125
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6042 0
Kareena Private Hospital - Caringbah
Recruitment postcode(s) [1] 13489 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 293945 0
Hospital
Name [1] 293945 0
Department of Anaesthesia, Kareena Hospital
Country [1] 293945 0
Australia
Primary sponsor type
Individual
Name
Dr Alwin Chuan
Address
Department of Anaesthesia
Kareena Private Hospital
86 Kareena Rd
Caringbah
NSW 2229
Country
Australia
Secondary sponsor category [1] 292767 0
None
Name [1] 292767 0
Address [1] 292767 0
Country [1] 292767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295368 0
North Shore Private HREC
Ethics committee address [1] 295368 0
3 Westbourne St
St Leonards
NSW 2065
Ethics committee country [1] 295368 0
Australia
Date submitted for ethics approval [1] 295368 0
06/06/2016
Approval date [1] 295368 0
29/07/2016
Ethics approval number [1] 295368 0

Summary
Brief summary
This is an observational trial of functional outcomes and chronic pain after elective shoulder surgery.
In this study, we will recruit adult patients admitted for elective shoulder surgery at Kareena Private Hospital. Baseline assessment will occur using the PostopQRS, modified Brief Pain Inventory (mBPI), Pain Catastrophizing Scale (PCS), Constant Shoulder Score (CSS), and the Western Ontario Rotator Cuff (WORC) scales. Major timepoints during follow up is Day 3 post-operative for cognitive recovery, Month 3 and 2 years for chronic pain rates, and shoulder function.

The primary outcome is Day 3 cognitive domain recovery as assessed using the PostopQRS tool. The secondary outcomes include:
1. Quality of recovery in the individual and overall recovery PostopQRS domains across all time periods up to Month 3 post-operative, in shoulder surgery patients when stratified by age, duration of surgery, and shoulder pathology.
2. Incidence of chronic post-surgical pain (CPSP) at Month 3, Year 1, and Year 2 post-operative, assessed using the mBPI, when stratified by age, duration of surgery, shoulder pathology, and PCS score

It is currently unknown what is the rate of medium to long term recovery after shoulder surgery. Our previous concept of recovery was limited to pain, nausea, and mobility in the first 24 hours, but relatively little is known about how patients recovery after major shoulder surgery over the ensuing weeks to months. This study aims to collect data to shed light into the rates of functional recovery and in particular, whether cognition is affected by anaesthesia. Similarly, the incidence of chronic post-surgical pain after shoulder surgery is relatively unknown. In other types of surgery, CPSP is common and impacts on quality of life, and has negative economic and social costs. As a secondary outcome, CPSP will be measured in this study at 3 months and 2 years post-operatively to determine the frequency of this complication.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67026 0
Dr Alwin Chuan
Address 67026 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67026 0
Australia
Phone 67026 0
+61 407743668
Fax 67026 0
Email 67026 0
[email protected]
Contact person for public queries
Name 67027 0
Dr Alwin Chuan
Address 67027 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67027 0
Australia
Phone 67027 0
+61 2 9828 3173
Fax 67027 0
Email 67027 0
[email protected]
Contact person for scientific queries
Name 67028 0
Dr Alwin Chuan
Address 67028 0
Department of Anaesthesia
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67028 0
Australia
Phone 67028 0
+61 407743668
Fax 67028 0
Email 67028 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn Evaluation of the Rotator Cuff Repair Research Pipeline.2018https://dx.doi.org/10.1177/2325967118805731
N.B. These documents automatically identified may not have been verified by the study sponsor.