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NCT05477303 Clinical Trial

Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05477303
Other study ID # B-2205-757-304
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 17, 2022
Est. completion date May 9, 2026

Study information
Verified date July 2022
Source Seoul National University Bundang Hospital
Contact InSun Park, MD
Phone 82317877499
Email pis121@hanmail.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date May 9, 2026
Est. primary completion date April 20, 2023
Accepts healthy volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• taking a picture of a painful facial expression
Immediately after surgery, the patient's facial expression and the NRS score and ANI score reported by the patient are checked together.

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyunggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Facial expression Painful facial expression immediately preoperative, postoperative time
Primary analgesia nociception index ANI score immediately preoperative, postoperative time
Primary numeric rating scale pain score immediately preoperative, postoperative time
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