University of Health Sciences Bursa Yüksek Ihtisas Training and Research Hospital
Bursa, Yıldırım, 16600, Turkey (Türkiye)
NCT Number: NCT07581678
Postoperative pain is a common and significant problem following open heart surgery. Fascial plane blocks (FPBs) such as the serratus anterior plane block (SAPB) and the 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 evaluated the anatomical success of ultrasound-guided fascial plane blocks applied in elective open heart surgery (median sternotomy). Block images were recorded in DICOM format and scored independently and blindly on a 3-point scale by five pre-trained, publicly available large vision-language models used as independent observers via zero-shot prompting (Gemini 3.5 Flash, Claude Sonnet 4.6, ChatGPT 5.5, Grok 4.3, Kimi AI 2.6), by three experienced anaesthesiologists, and by an adjudicator.
The primary analysis was the correlation between anatomical block success scores and postoperative pain (Numerical Rating Scale at rest and on coughing). Agreement between AI and human assessments, total analgesic consumption and clinical outcomes were analysed as secondary aims.
Note: this registration was originally entered from a superseded version of the protocol. The current approved protocol (version dated 29 April 2026) specifies pre-trained large vision-language models rather than a bespoke convolutional neural network. The record has been corrected accordingly; see Detailed Description.
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Notify Me18 year–80 year
All sexes
Observational
Bursa, Yıldırım, 16600, Turkey (Türkiye)
Patients scheduled for elective open heart surgery via median sternotomy were enrolled after obtaining written informed consent, including separate consent for AI-based image analysis. All patients underwent 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 were applied by a blinded anesthesiologist using a high-frequency linear ultrasound probe (10-15 MHz). The blocks applied included SAPB + PIFB combination or bilateral parasternal (PIFB) block, depending on the surgical decision. All blocks were performed using 0.25% bupivacaine (total 30-40 mL bilaterally) under sterile conditions with an in-plane technique.
Image Recording Protocol:
Block images were 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 were recorded in DICOM format (minimum 1920x1080 resolution) with standardized depth, gain, and focus settings. Patient identifiers were anonymized. From each recording, a standardized series of approximately 8-10 consecutive representative frames was compiled and presented identically to all assessors.
AI Assessment:
In accordance with the current approved protocol (dated 29 April 2026), five pre-trained, publicly available large vision-language models (Gemini 3.5 Flash, Claude Sonnet 4.6, ChatGPT 5.5, Grok 4.3, Kimi AI 2.6) were included as independent observers. Models were used as-is, without fine-tuning, retraining or any task-specific adaptation. Images were presented via standardised medical instructions (zero-shot prompting): for each patient a standardised series of approximately 8-10 consecutive anonymised frames was submitted in a new, independent session under an identical prompt, and each model returned a single 3-point classification.
The originally registered description (a bespoke convolutional neural network of U-Net/ResNet architecture, trained on expert-labelled reference images with 70/20/10 partitioning, evaluated by landmark-recognition accuracy, Dice coefficient and a 0-100 similarity score) was transcribed from a superseded version of the protocol. No bespoke model was developed, trained, or evaluated at any stage of the study, and none of those metrics were computed.
Block Quality Scoring:
Recorded ultrasound images were scored independently and blindly by the five AI models, by three anaesthesiologists experienced in fascial plane blocks, and by an adjudicator, using a 3-point scale:
Postoperative Follow-up:
NRS pain scores (at rest and with coughing) were assessed at 0, 6, 12, 24 and 48 hours. Assessment at 0 and 6 hours was not evaluable because all patients remained intubated and sedated at these time points; analyses use the 12, 24 and 48 hour assessments. Additional parameters recorded included total analgesic consumption, side effects (nausea, vomiting, pruritus), complications, mobilization time, ICU stay, and hospital length of stay.
Statistical Analysis:
Correlation between block success scores and postoperative pain scores was assessed using Spearman correlation. Factors affecting pain scores were evaluated by multiple linear regression. Agreement between assessors was quantified with linear weighted Cohen's kappa and Fleiss' kappa. Diagnostic-accuracy analyses against the adjudicator were not prespecified and are exploratory.
Sample Size:
The initially approved protocol specified 80 patients for 80% power at a 5% significance level, based on pilot data. An amendment petition dated 29 April 2026 requested an increase to 120 patients, stating that this raises statistical power for the primary correlation analysis from 80% to above 90% and secures sufficient analysable cases against image loss. The Ethics Committee decision (E-31234050-514.99-313724142, 6 May 2026) approved the increase in the approved sample size to 120. The figure of "95% power" in the original registration entry did not correspond to any protocol document and has been corrected. 120 patients were enrolled; 115 received a fascial plane block and were analysed.
Corrections and deviations:
This record was first submitted on 6 May 2026, after completion of data collection; registration was therefore retrospective. Prospective registration is not mandated for observational studies under ICMJE criteria. The protocol was approved by the institutional Ethics Committee on 13 August 2025 (2024-TBEK 2025/08-14), before the first patient was enrolled, and the design was prospective.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 48 hours postoperatively
Postoperative pain assessed using the Numerical Rating Scale (NRS) at rest and with coughing at 0, 6, 12, 24 and 48 hours after surgery. NRS ranges from 0 (no pain) to 10 (worst imaginable pain). Assessment at 0 and 6 hours was not evaluable as all patients remained intubated and sedated at these time points.
Time frame: Intraoperative
Comparison of fascial plane block anatomical success scores assigned by five pre-trained large vision-language models used as independent observers via zero-shot prompting, three blinded expert anaesthesiologists, and an adjudicator, using a 3-point scale (1: successful/optimal, 2: patchy/inadequate, 3: anatomically incorrect). Agreement assessed by linear weighted Cohen's kappa and Fleiss' kappa. Note: the original entry described a single trained CNN, a single blinded expert, and the reverse scale direction; see Corrections and deviations in the Detailed Description.
Time frame: 24 hours postoperatively
Total amount and type of analgesic agents consumed during the postoperative 24-hour period.
Time frame: Through ICU discharge, approximately 1-7 days
Duration of stay in the intensive care unit following open heart surgery.
Time frame: Through hospital discharge, approximately 5-10 days
Total duration of hospital stay following open heart surgery.
Time frame: 48 hours postoperatively
Incidence of postoperative complications including nausea, vomiting, pruritus, and other adverse events related to fascial plane blocks or analgesic use.
Time frame: Through hospital discharge, approximately 5-14 days
Time from end of surgery to first patient mobilization.
Bursa Yuksek Ihtisas Training and Research Hospital
Other Gov
AI-Assisted Evaluation of Anatomical Success of Fascial Plane Blocks Applied in Open Heart Surgery and Investigation of Its Relationship With Postoperative Pain Scores: A Prospective Observational Study
Acronym: FASCAI
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