NCT05477303

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2026

Expected
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

10 months

First QC Date

July 26, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

Immediately after surgery, the patient's facial expression and the NRS score and ANI score reported by the patient are checked together.

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, 13620, South Korea

RECRUITING

Related Publications (2)

  • Park I, Park JH, Yoon J, Na HS, Oh AY, Ryu J, Koo BW. Machine learning model of facial expression outperforms models using analgesia nociception index and vital signs to predict postoperative pain intensity: a pilot study. Korean J Anesthesiol. 2024 Apr;77(2):195-204. doi: 10.4097/kja.23583. Epub 2024 Jan 5.

  • Park I, Park JH, Yoon J, Song IA, Na HS, Ryu JH, Oh AY. Artificial intelligence model predicting postoperative pain using facial expressions: a pilot study. J Clin Monit Comput. 2024 Apr;38(2):261-270. doi: 10.1007/s10877-023-01100-7. Epub 2023 Dec 27.

MeSH Terms

Conditions

Facial ExpressionAgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Central Study Contacts

InSun Park, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical instructor

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

June 17, 2022

Primary Completion

April 20, 2023

Study Completion (Estimated)

May 9, 2026

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations