Artificial Intelligence Evaluation of Fascial Plane Block Quality and Postoperative Pain in Cardiac Surgery

NCT07581678 | Completed

• 1 other identifier: 2024-TBEK 2025708-14
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a common and significant problem following open heart surgery. Fascial plane blocks (FPBs) such as Serratus Anterior Plane Block (SAPB), Pectoral Nerve Blocks (PECS), and Pecto-Intercostal Fascial Block (PIFB) are increasingly used as part of multimodal analgesia in cardiac surgery. However, objective assessment of block quality and its relationship with clinical outcomes remains limited in the literature. This prospective observational study aims to evaluate the anatomical success of ultrasound-guided fascial plane blocks applied in elective open heart surgery (median sternotomy) using two simultaneous methods: a trained artificial intelligence (AI) model and a blinded expert anesthesiologist. Block images will be recorded in DICOM format and scored on a 3-point scale (1: incorrect anatomical placement, 2: patchy spread, 3: ideal anatomical placement). The relationship between anatomical block success scores and postoperative pain (NRS at 0, 6, 12, 24, and 48 hours), total analgesic consumption, and clinical outcomes will be investigated. Agreement between AI and blinded anesthesiologist assessments will also be analyzed.

Conditions

Pain, Postoperative; Cardiac Surgical Procedures; Nerve Block

Keywords

Fascial plane block; Open heart surgery; Artificial intelligence; Postoperative pain; Pecto-intercostal fascial block

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score

  Postoperative pain assessed using the Numerical Rating Scale (NRS) at rest and with coughing at 0, 6, 12, 24 hours after surgery. NRS ranges from 0 (no pain) to 10 (worst imaginable pain).

  48 hours postoperatively

Secondary Outcomes (6)

• Agreement Between AI and Blinded Anesthesiologist Block Quality Scores

  Intraoperative

• Total Analgesic Consumption

  24 hours postoperatively

• ICU Length of Stay

  Through ICU discharge, approximately 1-7 days

• Hospital Length of Stay

  Through hospital discharge, approximately 5-10 days

• Postoperative Complications

  48 hours postoperatively

Study Arms (1)

Fascial Plane Block Group

Patients scheduled for elective open heart surgery via median sternotomy who receive routine ultrasound-guided fascial plane blocks (bilateral parasternal PIFB block) under general anesthesia. Block images are independently scored by a trained AI model and a blinded expert anesthesiologist. Patients are followed postoperatively for pain scores, analgesic consumption, and clinical outcomes.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective open heart surgery via median sternotomy at the University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital, Department of Anesthesiology and Reanimation. All eligible patients who meet the inclusion criteria and provide written informed consent, including separate consent for AI-based ultrasound image analysis, will be enrolled consecutively.

You may qualify if:

• Age between 18-80 years
• Patients scheduled for elective cardiac surgery (CABG, valve surgery, combined procedures)
• Patients undergoing median sternotomy
• ASA physical status II-III
• Patients capable of providing informed consent, including separate consent for AI-based image analysis

You may not qualify if:

• Emergency surgery
• Redo sternotomy
• Allergy to local anesthetics
• Coagulopathy (INR \>1.5, platelet count \<80,000/mm³)
• Infection at the block application site
• Chronic opioid use (\>3 months)
• Cognitive dysfunction
• Pregnancy
• ASA physical status IV and above
• Minimally invasive surgery performed via thoracotomy

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital

Bursa, Yıldırım, 16600, Turkey (Türkiye)

Location

Related Publications (1)

• Bowness JS, Burckett-St Laurent D, Hernandez N, Keane PA, Lobo C, Margetts S, Moka E, Pawa A, Rosenblatt M, Sleep N, Taylor A, Woodworth G, Vasalauskaite A, Noble JA, Higham H. Assistive artificial intelligence for ultrasound image interpretation in regional anaesthesia: an external validation study. Br J Anaesth. 2023 Feb;130(2):217-225. doi: 10.1016/j.bja.2022.06.031. Epub 2022 Aug 18.

  PMID: 35987706 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)