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Trial registered on ANZCTR


Registration number
ACTRN12615000017527
Ethics application status
Not yet submitted
Date submitted
5/11/2014
Date registered
14/01/2015
Date last updated
14/01/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Does pain intensity measured on a scale from 0 to 10, in Chinese and Australian Caucasian patients increase unpredictably and if so do the unpredictable levels vary between the two ethnicities? A comparison using the relationships between pain intensity, and pain related functional interference, pain related beliefs and attitudes, pain management satisfaction and opioid related side effects
Scientific title
Identification of cut off points for pain intensity of Caucasian Australians and Chinese: A comparison involving preoperative beliefs and attitudes, and pain related functional interference, pain related beliefs and attitudes, pain management satisfaction and opioid related side effects following major surgery
Secondary ID [1] 285598 0
Nill known
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute postoperative pain 293441 0
Condition category
Condition code
Anaesthesiology 293714 293714 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study that compares two ethnic groups; Caucasian Australian and Chinese

In both groups there is no special intervention, they will both be observed after major surgery and measures of pain intensity, pain related interference, pain related beliefs and attitudes, pain management satisfaction and opioid related side effects taken.
Intervention code [1] 290549 0
Not applicable
Comparator / control treatment
This is an observational study that compares two ethnic groups; Caucasian Australian and Chinese

In both groups there is no special intervention, they will both be observed after major surgery and measures of pain intensity, pain related interference, pain related beliefs and attitudes, pain management satisfaction and opioid related side effects taken.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293520 0
Linearity of acute postoperative pain intensity (with reference to a 10 point Pain Numeric Rating Scale) in relation to pain related interference (a composite of movement , breathing, sleep and mood) in BOTH Caucasian Australian and Chinese populations. Subjects will be asked to quantify how much their pain has interfered with Movement, breathing, sleep and mood on a numeric rating scale where zero indicates no interference and 10 the greatest possible interference.
Timepoint [1] 293520 0
Relevant measurements for postoperative pain intensity in relation to pain related interference will take place once prior to surgery and once 24 hours following surgery.
Secondary outcome [1] 311246 0
Postoperative pain intensity (with reference to a 10 point Pain Numeric Rating Scale) cut off points for people of Caucasian Australian ethnicity compared to those of Chinese ethnicity relative to pain related interference (a composite of movement , breathing, sleep and mood). This will consist of plotting a graph of numeric rating scale pain intensity and pain related interference (consisting of a composite of pain related interference of movement breathing, mood, sleep) to investigate for steps in the graph indicative of cut off points.
Timepoint [1] 311246 0
Relevant measurements for postoperative pain intensity in relation to pain related interference will take place once prior to surgery and once 24 hours following surgery
Secondary outcome [2] 311247 0
Postoperative pain intensity (with reference to a 10 point Pain Numeric Rating Scale) cut off points for people of Caucasian Australian ethnicity compared to those of Chinese ethnicity relative to pain related beliefs and attitudes. This will consist of plotting a graph of numeric rating scale pain intensity and pain related beliefs and attitudes (measures on an ordinal scale)to investigate for steps in the graph indicative of cut off points.
Timepoint [2] 311247 0
Relevant measurements for postoperative pain intensity in relation to pain related beliefs and attitudes will take place once prior to surgery and once 24 hours following surgery
Secondary outcome [3] 311248 0
Postoperative pain intensity (with reference to a 10 point Pain Numeric Rating Scale) cut off points for people of Caucasian Australian ethnicity compared to those of Chinese ethnicity relative to satisfaction with analgesia management (15 point scale). This will consist of plotting a graph of numeric rating scale pain intensity and satisfaction with analgesia managment to investigate for steps in the graph indicative of cut off points.
Timepoint [3] 311248 0
Relevant measurements for postoperative pain intensity in relation to satisfaction with analgesia management will take place once, at 24 hours following surgery
Secondary outcome [4] 311249 0
Postoperative pain intensity (with reference to a 10 point Pain Numeric Rating Scale) cut off points for people of Caucasian Australian ethnicity compared to those of Chinese ethnicity relative to expereince of itch, nausea, vomiting and sedation after opioid administration. This will consist of plotting a graph of numeric rating scale pain intensity and itch (presence or absence of), nauseaor vomiting (presence or absence of), and sedation (depth of sedation using an ordinal scale) to investigate for steps in the graph indicative of cut off points.
Timepoint [4] 311249 0
Relevant measurements for postoperative pain intensity in relation to expereince of itch, nausea, vomiting and sedation after opioid administrationwill take place once, at 24 hours following surgery

Eligibility
Key inclusion criteria
1) Belong to appropriate ethnic group (Caucasian Australian in Australia, chinese in Hong Kong and Mainland China)

2) Spent most of life in country of recruitment

3) Both parents belong to same racial group

4) Able to understand instructions

5) Any type of surgery undertaken which has potential to cause pain in the first postoperative 24 hours.

Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presenting for repeat surgery

No pain present after surgery

Preoperative confusion

Severe depression

Prolonged unconsciousness after anaesthesia and surgery

Development of confusion following surgery

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical power analysis is based on numbers required for accurate analysis of primary and first secondary end points based on previous research by Serkin et al (see below for full reference). The recruitment power is based on numbers adequate to facilitate mutivariate analysis where a composite of pain related interference (movement, breathing, sleep,mood) will act as dependant variable and combinations of pain intensity rating cut offs for the mild/moderate and moderate/severe categories as the independant variable. This is as per Serlin RC, Mendoza TR, Nakamura Y et al. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995; 61: 277–84.


Combinations of potential cut off points on the pain intensity scale compared with pain related interference will be analysed in each ethnic population separately by multivariate analysis with comparison of F ratios using Pillai's trace, Wilk's lamda, and Hotelling's statistic with confirmation though two highest F ratios.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2015
Actual
Date of last participant enrolment
Anticipated
1/02/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3119 0
The Alfred - Prahran
Recruitment postcode(s) [1] 8868 0
3004 - St Kilda Road Melbourne
Recruitment outside Australia
Country [1] 6452 0
China
State/province [1] 6452 0
Zhejiang
Country [2] 6453 0
Hong Kong
State/province [2] 6453 0
Shatin

Funding & Sponsors
Funding source category [1] 290188 0
Hospital
Name [1] 290188 0
Pain Research Managment Fund
Alfred Hospital
Department of Anaesthesia and Perioperative Medicine
Country [1] 290188 0
Australia
Primary sponsor type
Individual
Name
Alex Konstantatos
Address
Alfred Hospital
Department of Anaesthesia and Perioperative Medicine
55 Commercial Rd
Melbourne
Victoria
Australia
3004
Country
Australia
Secondary sponsor category [1] 288900 0
Individual
Name [1] 288900 0
Matthew Chan
Address [1] 288900 0
Prince of Wales Hospital
Department of Anaesthetics
30-32 Ngan Shing St
Shatin
New Territories
Hong Kong
Country [1] 288900 0
Hong Kong
Other collaborator category [1] 278227 0
Individual
Name [1] 278227 0
Taidi Zhong
Address [1] 278227 0
Dept of Anesthesia
Sir Run Run Shaw Hospital
3 Quinchun East Rd
Hangzhou
Zhejiang 31006
China
Country [1] 278227 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291899 0
Alfred Health Ethics Committee
Ethics committee address [1] 291899 0
Alfred Hospital
55 Commercial Rd
Melbourne 3004
Victoria
Australia
Ethics committee country [1] 291899 0
Australia
Date submitted for ethics approval [1] 291899 0
29/12/2014
Approval date [1] 291899 0
Ethics approval number [1] 291899 0
Ethics committee name [2] 291900 0
Prince of Wales Hospital Institutional Review Board
Ethics committee address [2] 291900 0
Prince of Wales Hospital
30-32 Ngan Shing St
Shatin
New Territories
Hong Kong
Ethics committee country [2] 291900 0
Hong Kong
Date submitted for ethics approval [2] 291900 0
29/12/2014
Approval date [2] 291900 0
Ethics approval number [2] 291900 0
Ethics committee name [3] 291901 0
Sir Run Run Shaw Hospital Institutional Review Board
Ethics committee address [3] 291901 0
Sir Run Run Shaw Hospital
3 Quingchun East Rd
Hangzhou
Zhejiang 31006
China
Ethics committee country [3] 291901 0
China
Date submitted for ethics approval [3] 291901 0
30/03/2015
Approval date [3] 291901 0
Ethics approval number [3] 291901 0

Summary
Brief summary
There are several established methods in Pain Medicine where a patient is able to describe the intensity of their pain. The most popular involve scoring pain intensity using a numeric scale comprising numbers from 1 to 10 and a visual scale which is 10 cm long and allows a clinician to measure the visual rating out of 10.

Both these methods of pain intensity measurement carry the assumption that pain intensity increases in a predictable way as the numbers on these two measurement scales might indicate. The truth is that this is not likely to be true. The World Health Organization, for example, places great significance on a cancer pain rating that is higher than 3 out of 10, recommending that treatment for pain greater than 3 out of 10 be escalated.

The most likely reason for changes in pain intensity not being even and predictable is that pain intensity is only a small part of overall pain experience. Pain intensity is influenced by many other factors, including the context of the pain (its effect on movement, sleep, mood), side effects of medications, anticipation of pain severity prior to pain experience, attitudes and beliefs relating to pain experience and satisfaction with the experience of pain management just to mention a few.

There are statistical methods that can help us to explore how pain intensity changes as it increases. These complex methods can be applied though analysis of various measurements from patients, which can be easily collected in observational studies. The results of these analyses can then be used to look for steep “steps” in the pain intensity scale among populations of patients which indicate that pain level has increased to a greater degree than the gaps between the numbers on the pain rating scale might indicate. It is the numeric value where these steps occur, for example at a pain level of 3 out of 10 where recommendations to escalate pain treatment might be appropriate. Such points have already been identified in populations of patients affected by cancer pain, chronic pain as well as patients after surgery. There is only one study which examined a multiethnic population, the study involving cancer pain.

A group of researchers that I have been working with have identified several factors that are very different in patients of Chinese ethnicity compared with patients of Caucasian ethnicity after major surgery. Many of these factors (Chinese people were more likely to defer analgesic management to their managing doctors, had greater expectation of severe postoperative pain, greater susceptibility to itch with morphine, lesser satisfaction with pain management) are likely to create “steps” in pain intensity scales that may differ significantly between these two races. We hope to compare two populations of 450 patients after surgery from China and Australia in order to confirm this belief as pain treatment escalation may need to be set at different levels in accordance with ethnicity.


Trial website
Trial related presentations / publications
Public notes
Attachments [1] 227 227 0 0
/AnzctrAttachments/367363-protocol.doc

Contacts
Principal investigator
Name 52510 0
Dr Alex konstantatos
Address 52510 0
C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004
Country 52510 0
Australia
Phone 52510 0
+61 3 90763176
Fax 52510 0
Email 52510 0
A.Konstantatos@alfred.org.au
Contact person for public queries
Name 52511 0
Dr Alex konstantatos
Address 52511 0
C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004
Country 52511 0
Australia
Phone 52511 0
+61 3 90763176
Fax 52511 0
Email 52511 0
A.Konstantatos@alfred.org.au
Contact person for scientific queries
Name 52512 0
Dr Alex Konstantatos
Address 52512 0
C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004
Country 52512 0
Australia
Phone 52512 0
+61 3 90763176
Fax 52512 0
Email 52512 0
A.konstantatos@alfred.org.au

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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