Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT05480111 - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy Phase 4
Completed NCT06129305 - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed NCT04401826 - Micro-surgical Treatment of Gummy Smile N/A
Recruiting NCT04020133 - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction. N/A
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT03652103 - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy Phase 4
Completed NCT03546738 - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery N/A
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Terminated NCT03261193 - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain Phase 3
Completed NCT02525133 - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty Phase 3
Completed NCT03244540 - Regional Analgesia After Cesarean Section Phase 4
Enrolling by invitation NCT05316168 - Post Operative Pain Management for ACL Reconstruction Phase 3
Recruiting NCT04130464 - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management Phase 4
Enrolling by invitation NCT04574791 - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty N/A
Completed NCT04526236 - Influence of Aging on Perioperative Methadone Dosing Phase 4
Completed NCT04073069 - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults Phase 4
Recruiting NCT05351229 - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery Phase 4
Enrolling by invitation NCT05543109 - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block N/A
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2