ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000040662

Ethics application status

Approved

Date submitted

28/03/2022

Date registered

16/01/2023

Date last updated

16/01/2023

Date data sharing statement initially provided

16/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Using facial patterns from artificial intelligence facial recognition to guide and optimise treatment with opioid medications following painful surgery

Scientific title

Prospective Randomized Controlled Trial- Artificial Intelligence facial recognition to guide opioid de-escalation following painful surgery

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

This study is a follow up study to ACTRN12620000865910

Health condition

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

opioid use disorder

post operative surgical pain

Condition category

Condition code

Anaesthesiology

Pain management

Public Health

Epidemiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will utilise artificial intelligence facial pattern recognition using specialised software to interpret films of facial expressions of patients after they have received premedication with opioid prior to their surgery. The filming will involve asking the patient to look ahead with a normal facial expression at which time the camera will record their face for 2 minutes. The patient will not be asked to produce any specific facial expressions, for example smiling or frowning. The film will be interpreted by experts in facial recognition who will identify special features of facial expression that predispose previously opioid naïve patients to prolonged opioid requirement following surgery. The patients who are considered at risk of prolonged opioid requirement will then receive opioid de-escalation intervention delivered by trained pharmacists. The opioid de-escalation will involve repeated visits with education about opioids and review of postoperative pain from trained pharmacists. The education will involve casual verbal conversation which will focus on pain severity ratings, the role of opioids to control and not necessarily take away pain following surgery and the need to reduce opioid dosing with time following surgery provided pain severity is controlled. Each meeting with pharmacists will take approximately 20 minutes. Reduction of opioid will be approximately 25-50% every (1-3) days provided pain intensity keeps falling or remains the same and there is no surgical complication. Pharmacists will visit participants daily while the patient is in hospital and communicate via phone after the patient is discharged from hospital twice weekly. Pharmacist intervention will continue until the patient has ceased their opioid. Treatment provided by pharmacists will be personalized in accordance with participant recorded pain intensity. Adherence to opioid de-escalation will be monitored though recording of opioid use. Family doctors will be informed as to patient treatment and may follow up as per usual practice.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Intervention code [3]

Treatment: Other

Comparator / control treatment

Facial recognition data will be collected and interpreted for patient blinding but will not be used to guide therapy Surgical residents will manage opioids during the surgical recovery period using their existing knowledge with involvement of pharmacists who help with dispensing and provide basic education. Following discharge from hospital communication of the patients surgery and therapy will be made with the family physician continues to provide follow-up.

Control group

Active

Outcomes

Primary outcome [1]

Duration of opioid therapy following surgery. This will be collected by data linkage to medical records while the patients remain in hospital and via telephone follow-up after the patient leaves hospital if relevant i.e. if they continue to take opioids.

Timepoint [1]

The data collection for the primary timepoint will cease at 5 days after the patient has remained opioid free and be measured in total days of opioid requirement. this may range from days to weeks.

Secondary outcome [1]

Early postoperative NRS pain intensity score

Timepoint [1]

pain intensity for 48 hrs after surgery

Secondary outcome [2]

Mean NRS pain intensity during opioid therapy duration

Timepoint [2]

Pain intensity measured daily for the period during which the patient requires opioid therapy. This may range from days to weeks.

Eligibility

Key inclusion criteria

- Painful surgery, all types allowed, with stratification for surgeries perceived as more painful incorporated in the randomisation.
- Age 18-80 yrs
- Able to understand concept of Artificial Intelligence
- Where significant perioperative opioid therapy is planned.
- General anaesthetic planned
- Where first dose of intravenous opioid administered pre-induction is allowed by anaesthetist (to allow AI facial recognition filming).

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Those receiving opioids or atypical opioids (tapentadol, tramadol) in the two weeks preceding surgery
- Not willing to have AI facial recognition evaluation
- Unable to understand procedure
- Current opioid use disorder and current illicit drug use
- Contraindications to use of significant opioid
- Parkinsons Disease, Cerebrovascular accident impairing facial expression, Use of anti-psychotic medication likely to affect facial expression, Surgery involving head and neck.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by phone/fax/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

This is a feasibility study that will focus on whether methodology is practical and realistically and easily applicable . It will assess 40 patients. It will be conducted with a view to planning a larger study that will require approximately 1500 participants. Data from the 40 patients will be used to calculate opioid duration data that will be used for power analysis to confirm numbers needed for the larger study ( looking for a 20% reduction in duration of postoperative opioid therapy duration with intervention)

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2023

Actual

Date of last participant enrolment

Anticipated

1/06/2024

Actual

Date of last data collection

Anticipated

1/07/2024

Actual

Sample size

Target

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]

1/58 Lorimer St Docklands VIC 3008

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Alex Konstantatos

Address

Alfred Hospital Department of Anesthesiology and Perioperative Medicine
Alfred Hospital
Commercial Rd
Melbourne
Victoria
3004

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Strong Room Technologies

Address [1]

Strong Room Technologies
1/58 Lorimer St
Docklands
Victoria
3008

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Research and Ethics Committee

Ethics committee address [1]

C/o Alfred Hospital
Commercial Rd
Melbourne
VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/05/2022

Approval date [1]

09/11/2022

Ethics approval number [1]

Summary

Brief summary

This is a study that aims to identify patients that might be susceptible to prolonged requirement for opioids after painful surgery. It will do this by using facial recognition technology before surgery to see whether participants respond to a specialised pharmacologic intervention to minimise unnecessary opioid use.  It will do so by comparing this intervention with usual care to see whether there is an overall reduction of days where opioid therapy is needed following surgery between two groups. One group will use information from Artificial Intelligence prior to surgery to identify facial characteristics predicting prolonged opioid requirement following surgery, Those with predicted prolonged opioid requirement  will have  postoperative pain managed in close conjunction with a pharmacist. They will be involved in a detailed program where they are reviewed regularly and, if circumstances are appropriate, have their opioid dose reduced proactively. This is known as pharmacy-led opioid de-escalation. It comprises management by an accredited clinical pharmacist providing an individualised plan aiming for detailed patient education together with opioid reduction of approximately 25-50% every (1-3) days. The plan will take pain intensity scores into consideration. Increasing pain intensity scores will result in no de-escalation, whilst unchanged and decreasing pain scores will result in reduction of opioid of approximately 25-50% every (1-3) days. The clinical pharmacist will also continue to closely follow progress of patients assigned to opioid de-escalation after discharge from hospital to continue the de-escalation pathway until cessation of all opioid analgesics, often working in conjunction with a family doctor. The other group  will be randomly allocated to receive usual care for their postoperative pain. This comprises filming the participant but not acting on the results of the AI facial recognition analysis. All participants in this group will be subject to current practice whereby surgical residents (young doctors working with the surgical team) manage opioids after the acute recovery period using their existing knowledge with involvement of pharmacists who help with dispensing and provide basic education. Following discharge from hospital the family physician continues to provide follow-up.  The main measure of the study will be the time in days of opioid requirement compared between the two groups.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alex Konstantatos

Address

Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
Alfred hospital
commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61425702049

Fax

alex.konstantatos@gmail.com

Contact person for public queries

Name

Alex Konstantatos

Address

Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
Alfred hospital
commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 32763176

Fax

alex.konstantatos@gmail.com

Contact person for scientific queries

Name

Alex Konstantatos

Address

Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
Alfred hospital
commercial Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 32763176

Fax

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

IPD will not be made available as the data is sensitive

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

No additional documents have been identified.

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