None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dr Alex Konstantatos
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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).
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.
Outcome results
None listed