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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] 300972 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 317005 0
opioid addiction 317006 0
surgery 318106 0
addiction 318107 0
Condition category
Condition code
Anaesthesiology 315168 315168 0 0
Pain management
Surgery 315554 315554 0 0
Other surgery
Mental Health 315555 315555 0 0
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] 317299 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323429 0
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] 323429 0
at point where anaesthetic is ceased and muscle relaxant following surgery
Primary outcome [2] 323430 0
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] 323430 0
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] 381922 0
correlation of 3D facial expression with first dose of opioid to manage pain in the post anaesthesia care unit with opioid duration
Timepoint [1] 381922 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16407 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 29952 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 305419 0
Commercial sector/Industry
Name [1] 305419 0
Strong Room Technologies
Address [1] 305419 0
58 The Boulevard
Malvern East
Melbourne
Victoria
3145
Country [1] 305419 0
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] 305810 0
None
Name [1] 305810 0
Address [1] 305810 0
Country [1] 305810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305740 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 305740 0
Alfred Hospital
Commercial Rd
Melbourne
Victoria
3004
Australia
Ethics committee country [1] 305740 0
Australia
Date submitted for ethics approval [1] 305740 0
27/04/2020
Approval date [1] 305740 0
16/07/2020
Ethics approval number [1] 305740 0

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 101422 0
Dr Alex Konstantatos
Address 101422 0
Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC
Country 101422 0
Australia
Phone 101422 0
+61 3 9076 3176
Fax 101422 0
+61 3 9076 2813
Email 101422 0
a.konstantatos@alfred.org.au
Contact person for public queries
Name 101423 0
Dr Alex Konstantatos
Address 101423 0
Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC
Country 101423 0
Australia
Phone 101423 0
+61 3 9076 3176
Fax 101423 0
+61 3 9076 2813
Email 101423 0
a.konstantatos@alfred.org.au
Contact person for scientific queries
Name 101424 0
Dr Alex Konstantatos
Address 101424 0
Alfred Hospital
Department of Anaesthesiology and Perioperative Medicine
Commercial Rd
Melbourne
3004 VIC
Country 101424 0
Australia
Phone 101424 0
+61 3 9076 3176
Fax 101424 0
+61 3 9076 2813
Email 101424 0
a.konstantatos@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?
Study protocol
Informed consent form
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7581 0
Study protocol
Citation [1] 7581 0
Link [1] 7581 0
Email [1] 7581 0
a.konstantatos@alfred.org.au
Other [1] 7581 0
Attachment [1] 7581 0
Type [2] 7584 0
Informed consent form
Citation [2] 7584 0
Link [2] 7584 0
Email [2] 7584 0
a.konstantatos@alfred.org.au
Other [2] 7584 0
Type [3] 8991 0
Ethical approval
Citation [3] 8991 0
Link [3] 8991 0
Email [3] 8991 0
Other [3] 8991 0
Type [4] 8992 0
Study protocol
Citation [4] 8992 0
Link [4] 8992 0
Email [4] 8992 0
Other [4] 8992 0
Summary results
No Results