AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment

NCT07171502 | Completed

• 1 other identifier: AI-Sacral Plexus
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks.

Conditions

Ultrasound-Guided Nerve Blocks; AI (Artificial Intelligence)

Outcome Measures

Primary Outcomes (1)

• The accuracy of identifying the target anatomical structures in the annotated images.

  From enrollment to the end of treatment at 4 months

Secondary Outcomes (6)

• The number of true positive (TP) structures

  From enrollment to the end of treatment at 4 months

• The number of false positive (FP) structures

  From enrollment to the end of treatment at 4 months

• The number of true negative (TN) structures

  From enrollment to the end of treatment at 4 months

• The number of false negative (FN) structures

  From enrollment to the end of treatment at 4 months

• The annotation time (time from the start to the end of annotation)

  From enrollment to the end of treatment at 4 months

Study Arms (2)

AI Annotation

EXPERIMENTAL

Device: AI Annotation

Manual Annotation

PLACEBO COMPARATOR

Other: manual annotation

Interventions

AI Annotation DEVICE

Use the AI model to assist in annotating the target images.

AI Annotation

manual annotation OTHER

Use the manual to annotate the target images.

Manual Annotation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years
• BMI between 19-23 kg·m-²
• ASA physical status classification I-II
• Normal orientation and able to cooperate with physical examination.

You may not qualify if:

• Patient refusal
• Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site
• Pregnancy

Sponsors & Collaborators

• Shanghai Jiao Tong University Affiliated Sixth People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital Affiliated with Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 12, 2025
• Study Start: September 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-09

Locations

CN (1)