ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000865910

Ethics application status

Approved

Date submitted

9/04/2020

Date registered

31/08/2020

Date last updated

31/08/2020

Date data sharing statement initially provided

31/08/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Using patterns of facial expression to assist the management of pain and predict excessive reliance for opioid medications after pain surgery

Scientific title

Facial recognition to predict acute pain and opioid requirement in a population of patients having major elective surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

chronic pain

opioid addiction

surgery

addiction

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

Other surgery

Mental Health

Addiction

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Video of facial expressions which are then interpreted by computer programme. The computer programme analyses participant videos for common patterns of facial expression among participants that are:
- linked to the presence of pain (as determined by behavioural pain scores measured after the video)
- linked to longer duration of requirement of opioids following surgery

Each video will be performed for 2 minutes;
1) prior to commencement of surgery as baseline
2) Just after opioid administered prior to commencement of anaesthesia
3) after surgery and anaesthesia completed prior to waking fully
4) when opioid is administered, prior to and after surgery
- The video will be performed by the research assistant in all cases
- All the videos will take place in theatre

Each participant will be followed up following surgery until such a time as they have finished taking opioid to treat their pain. This will be for a period of one month following discharge from hospital

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Correlation of facial expressions uses 3D mapping from video using a computer programme. Each face will have multiple areas identified and the computer will look for discrete facial expressions that participants share in common when they might experience pain early in the waking process. These expressions will be compared to the behavioural pain scale (assessed by observer; the research assistant) to see if there are facial expression patterns that patients have in common when they are observed to have higher behavioural pain scores.
The same facial points identified during video recording will identify whether there are special facial expression patterns that patients show after receiving opioid prior to surgery and to treat pain after surgery, that correlate with a need to continue opioids for longer after completing surgery. Duration of opioid requirement following surgery will be measured by the research assistant

Timepoint [1]

at point where anaesthetic is ceased and muscle relaxant following surgery

Primary outcome [2]

correlation of 3D facial expression after receiving opioid before surgery with duration of opioid requirements following surgery. i.e.
computer programmes look for discrete facial expressions that participants share in common when longer duration of opioid requirement is measured after patient discharge from hospital

Timepoint [2]

time ranges from when patient wakes up from surgery until they have finished requiring opioid to treat their postoperative pain. this may range from 1 day to several weeks. Time points will be daily until discharge then every 48 hours after discharge for 1 week then weekly thereafter until that person has ceased their opioids

Secondary outcome [1]

correlation of 3D facial expression with first dose of opioid to manage pain in the post anaesthesia care unit with opioid duration

Timepoint [1]

1)3D facial expression is conducted:
-prior to commencement of surgery or anaesthetic (baseline)
- prior to surgery when opioid is given
- after surgery just after the first dose of opioid is administered in the post anaesthesia care unit to treat pain
- at completion of surgery before patient wakes up (and after muscle relaxant administered)

Eligibility

Key inclusion criteria

Over 18 years of age
Having major surgery requiring multi day admission and general anaesthesia
Opioid therapy planned by anaesthetist for postoperative pain manamgent

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Under 18 or over 80 years of age
Poor English language comprehension
Having received opioid analgesia in the two weeks prior to surgery
Current or previous diagnosis of opioid disorder
Current or previous diagnosis of illicit drug use disorder

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

We cannot reliably estimate a sample size because of uncertain nature of measuring 3D facial expressiveness but feel that 120 participants should give us sufficient data for proof of concept.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2020

Actual

Date of last participant enrolment

Anticipated

31/07/2021

Actual

Date of last data collection

Anticipated

31/08/2021

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Strong Room Technologies

Address [1]

58 The Boulevard
Malvern East
Melbourne
Victoria
3145

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Strong Room technologies

Address

58 The Boulevard
Malvern East
Melbourne
Victoria
3145

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Research and Ethics Committee

Ethics committee address [1]

Alfred Hospital
Commercial Rd
Melbourne
Victoria
3004
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2020

Approval date [1]

16/07/2020

Ethics approval number [1]

Summary

Brief summary

The study will observe patients receiving usual care for major surgery where multi day stay is likely. It will capture video footage of patients faces prior to surgery (as a baseline) and also prior to surgery after they receive opioid as part of their anaesthetic, as they begin to wake from their anaesthetic but are not yet awake, and after they receive their first dose of opioid in the post anaesthesia care unit.
The video recordings will then be analysed using a computer program for artificial intelligence facial recognition and information from this analysis will be correlated with known measurements tools to evaluate whether there is correlation between:
- pain intensity levels and pain intensity measured with the behavioural pain intensity scale
-specific facial expressions that indicate susceptibility to prolonged requirement for opioid analgesia
Our hypothesis are that
1) there is strong correlation between facial expressions as measured by 3D facial mapping and pain intensity before waking from anaesthesia
2) there is strong correlation between certain facial expressions as measured by 3D facial mapping and susceptibility to opioid as expressed by prolonged duration of opioid requirement following surgery

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alex Konstantatos

Address

Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC

Country

Australia

Phone

+61 3 9076 3176

Fax

+61 3 9076 2813

a.konstantatos@alfred.org.au

Contact person for public queries

Name

Alex Konstantatos

Address

Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC

Country

Australia

Phone

+61 3 9076 3176

Fax

+61 3 9076 2813

a.konstantatos@alfred.org.au

Contact person for scientific queries

Name

Alex Konstantatos

Address

Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC

Country

Australia

Phone

+61 3 9076 3176

Fax

+61 3 9076 2813

a.konstantatos@alfred.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We will only share the summarised data after it has been made re-identifiable

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
7581	Study protocol	a.konstantatos@alfred.org.au
7584	Informed consent form	a.konstantatos@alfred.org.au	379591-(Uploaded-28-08-2020-15-31-43)-Study-related document.docx
8991	Ethical approval		379591-(Uploaded-28-08-2020-15-29-41)-Study-related document.pdf
8992	Study protocol		379591-(Uploaded-28-08-2020-15-30-42)-Study-related document.docx

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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