Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression

Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression Recognition and Analgesia Nociception Index

Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Analgesia; Artificial Intelligence; Facial Expression
• Intervention / Treatment: Other: taking a picture of a painful facial expression

Detailed Description

Analgesia nociception index (ANI 0-100) and patient-reported numeric rating scale (NRS 0-10) were trained on a convolutional neural network (CNN) model by linking the patients' facial expression with the score. By applying the predicted pain score by the AI model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: InSun Park, MD; Phone Number: 82317877499; Email: pis121@hanmail.net

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seongnam-si, Gyunggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: InSun Park, MD; Phone Number: 82317877507; Email: pis121@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who were scheduled for elective laparoscopic abdominal surgery under general anesthesia

Description

Inclusion Criteria:

• Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia
• American Society of Anesthesiology (ASA) class I-II

Exclusion Criteria:

• Patients who have difficulty in communicating and reporting pain
• Underlying diseases: liver, kidney, brain
• Patients with BMI greater than 30 and less than 18.5
• Alcohol or drug dependent patients
• Patients with severe or acute respiratory failure
• Opioid, NSAID allergy
• Patients who are scheduled to be admitted to the intensive care unit after surgery
• Patients who undergo cooperative surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial expression	Painful facial expression	immediately preoperative, postoperative time
analgesia nociception index	ANI score	immediately preoperative, postoperative time
numeric rating scale	pain score	immediately preoperative, postoperative time

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2022
• Primary Completion (ANTICIPATED): April 20, 2023
• Study Completion (ANTICIPATED): May 9, 2026

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (ACTUAL): July 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Facies
• Other Study ID Numbers: B-2205-757-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No