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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.
Patients scheduled for elective open heart surgery via median sternotomy will be enrolled after obtaining written informed consent, including separate consent for AI-based image analysis. All patients will undergo routine anesthetic management including BIS monitoring, intra-arterial cannulation, standard anesthesia induction, orotracheal intubation, and central venous catheterization.
Fascial Plane Block Application:
Following general anesthesia induction, fascial plane blocks routinely performed in our clinic will be applied by a blinded anesthesiologist using a high-frequency linear ultrasound probe (10-15 MHz, G-brand). The blocks applied include SAPB + PIFB combination or bilateral parasternal (PIFB) block, depending on the surgical decision. All blocks will be performed using 0.25% bupivacaine (total bilaterally 30 mL) under sterile conditions with an in-plane technique.
Image Recording Protocol:
Block images will be recorded in a standardized manner including: pre-block anatomical scanning, video recording during needle placement, local anesthetic spread images, and post-injection final images. All images will be recorded in DICOM format (minimum 1920x1080 resolution) with standardized depth, gain, and focus settings. Patient identifiers will be anonymized.
AI Model Development:
A Convolutional Neural Network (CNN)-based model (U-Net or ResNet architecture) will be trained using expert-labeled ultrasound images from NYSORA references. The dataset will be divided into 70% training, 20% validation, and 10% test sets using data augmentation and cross-validation techniques. The model will evaluate anatomical landmark recognition accuracy, local anesthetic spread segmentation (Dice coefficient), and similarity to ideal block (0-100 score).
Block Quality Scoring:
Recorded ultrasound images will be independently scored by both the trained AI model and a blinded expert anesthesiologist using a 3-point scale:
Postoperative Follow-up:
Patients will be followed postoperatively with NRS pain scores (at rest and with coughing) at 0, 6, 12, 24. Additional parameters recorded include total analgesic consumption, side effects (nausea, vomiting, pruritus), complications, mobilization time, ICU stay, and hospital length of stay.
Statistical Analysis:
Correlation between AI scores and postoperative pain scores will be assessed using Pearson or Spearman correlation. Factors affecting pain scores will be evaluated by multiple linear regression. Differences between block types will be analyzed using ANOVA or Kruskal-Wallis test. Agreement between AI and blinded anesthesiologist assessments will be analyzed using Cohen's kappa coefficient.
Sample Size:
Based on pilot study data, 120 patients are planned with 95% power.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between AI and Blinded Anesthesiologist Block Quality Scores | Comparison of fascial plane block anatomical success scores assigned by the trained AI model and the blinded expert anesthesiologist using a 3-point scale (1: incorrect, 2: patchy, 3: ideal). Agreement assessed by Cohen's kappa coefficient. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital | Bursa | Yıldırım | 16600 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35987706 | Background | 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. |
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Individual participant data will not be shared due to patient privacy and confidentiality concerns, as the study involves anonymized ultrasound images and clinical data collected at a single center. Data may be made available upon reasonable request to the principal investigator.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Total Analgesic Consumption |
Total amount and type of analgesic agents consumed during the postoperative 24-hour period. |
| 24 hours postoperatively |
| ICU Length of Stay | Duration of stay in the intensive care unit following open heart surgery. | Through ICU discharge, approximately 1-7 days |
| Hospital Length of Stay | Total duration of hospital stay following open heart surgery. | Through hospital discharge, approximately 5-10 days |
| Postoperative Complications | Incidence of postoperative complications including nausea, vomiting, pruritus, and other adverse events related to fascial plane blocks or analgesic use. | 48 hours postoperatively |
| Time to Mobilization | Time from end of surgery to first patient mobilization. | Through hospital discharge, approximately 5-14 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |