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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]

Nill known

Universal Trial Number (UTN)

Trial acronym

None

Linked study record

Health condition

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

acute postoperative pain

Condition category

Condition code

Anaesthesiology

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]

Not applicable

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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?

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]

The Alfred - Prahran

Recruitment postcode(s) [1]

3004 - St Kilda Road Melbourne

Recruitment outside Australia

Country [1]

China

State/province [1]

Zhejiang

Country [2]

Hong Kong

State/province [2]

Shatin

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Pain Research Managment Fund
Alfred Hospital
Department of Anaesthesia and Perioperative Medicine

Address [1]

Alfred Hospital
Department of Anaesthesia and Perioperative Medicine
55 Commercial Rd
Melbourne
Victoria
Australia
3004

Country [1]

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]

Individual

Name [1]

Matthew Chan

Address [1]

Prince of Wales Hospital
Department of Anaesthetics
30-32 Ngan Shing St
Shatin
New Territories
Hong Kong

Country [1]

Hong Kong

Other collaborator category [1]

Individual

Name [1]

Taidi Zhong

Address [1]

Dept of Anesthesia
Sir Run Run Shaw Hospital
3 Quinchun East Rd
Hangzhou
Zhejiang 31006
China

Country [1]

China

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Alfred Health Ethics Committee

Ethics committee address [1]

Alfred Hospital
55 Commercial Rd
Melbourne 3004
Victoria
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/12/2014

Approval date [1]

Ethics approval number [1]

Ethics committee name [2]

Prince of Wales Hospital Institutional Review Board

Ethics committee address [2]

Prince of Wales Hospital
30-32 Ngan Shing St
Shatin
New Territories
Hong Kong

Ethics committee country [2]

Hong Kong

Date submitted for ethics approval [2]

29/12/2014

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Sir Run Run Shaw Hospital Institutional Review Board

Ethics committee address [3]

Sir Run Run Shaw Hospital 
3 Quingchun East Rd
Hangzhou
Zhejiang 31006
China

Ethics committee country [3]

China

Date submitted for ethics approval [3]

30/03/2015

Approval date [3]

Ethics approval number [3]

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]

/AnzctrAttachments/367363-protocol.doc

Contacts

Principal investigator

Name

Dr Alex konstantatos

Address

C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004

Country

Australia

Phone

+61 3 90763176

Fax

A.Konstantatos@alfred.org.au

Contact person for public queries

Name

Alex konstantatos

Address

C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004

Country

Australia

Phone

+61 3 90763176

Fax

A.Konstantatos@alfred.org.au

Contact person for scientific queries

Name

Alex Konstantatos

Address

C/o Alfred Hospital
55 Commercial Rd
Melbourne
Victoria
Australia
3004

Country

Australia

Phone

+61 3 90763176

Fax

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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Documents added automatically

No additional documents have been identified.

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