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Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies

Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06480045
Enrollment
70
Registered
2024-06-28
Start date
2021-11-05
Completion date
2023-05-05
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

mastectomy, pectoral nerve block, USG, artificial intelligence

Brief summary

The investigator's goal in this study is to apply PECS II block, before starting surgery, by either conventional USG or artificial intelligence integrated USG to patients who will undergo mastectomy under general anesthesia to determine the effect of the block on hemodynamics and opioid consumption in the intraoperative period. Besides, the investigatorwanted to investigate the contribution of artificial intelligence integrated USG use in the success of a 4-year anesthesiology resident for imaging the injection site.

Detailed description

After receiving the approval of the Clinical Research Ethics Committee of Başkent University (KA21/353), 70 patients with ASA I-II, between the ages of 18-75, who were scheduled for mastectomy surgery were included in the study. A 4. year anesthesiology resident under the supervision of two senior anesthesiologists, performed a PECS II block with AI-integrated USG or conventional USG (Group AI-USG and Group USG) after randomization. Although the resident had no experience with pectoral blocks, she had experience with the use of USG and regional anesthesia related to other trunk-area and peripheral blocks. The block was performed after induction of general anesthesia. Patient data in terms of hemodynamic changes in the intraoperative period, opioid (remifentanil) consumption, and postoperatively hemodynamics, pain scores (VAS), postoperative opioid \[tramadol administered with a patient-controlled analgesia pump (PCA)\] and, if necessary, rescue analgesic agent (non-steroidal antiinflammatory agent) consumption were monitored in the post anesthesia care unit (PACU), and at postoperative 6., 12. and 24.hours.

Interventions

PROCEDUREPerformed PECS II block with AI integrated USG

A 4-year anesthesiology resident, under the supervision of two senior anesthesiologists, performed a PECS II block with AI-integrated USG.

PROCEDUREPerformed PECS II block with conventional USG

A 4-year anesthesiology resident, under the supervision of two senior anesthesiologists, performed a PECS II block with conventional USG.

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

70 patients with ASA I-II, between the ages of 18-75, who were scheduled for mastectomy surgery were included in the study. An anesthesiology resident under the supervision of senior anesthesiologist, performed a PECS II block with AI-integrated USG or conventional USG (Group AI-USG and Group USG) after randomization. Block was performed after induction of general anesthesia. Patient data in terms of hemodynamic changes in the intraoperative period, opioid consumption, and postoperatively hemodynamics, pain scores (VAS), postoperative opioid (tramadol administered with a patient-controlled analgesia pump) and, if necessary, rescue analgesic agent (non-steroidal antiinflammatory agent) consumption were monitored in the post-anesthesia care unit, and at postoperative 6., 12. and 24.hours.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 18-70 years * ASA I and II * Female * Underwent mastectomy surgery * Without local anesthetic allergy

Exclusion criteria

* Patients with ASA III and above * Obesity (body mass index \>30) * Psychotropic drug use * Bleeding diathesis * Local anesthetic allergy * Chest wall deformity * Infection at the injection site * Chronic analgesic usage

Design outcomes

Primary

MeasureTime frameDescription
Pain in the postoperative period was evaluated using the VAS score.24 hoursThe researchers investigate whether postoperative pain increases or decreases, using the VAS score at the postoperative anesthesia care unit, at postoperative 6 hours, 12 hours, and 24 hours.

Secondary

MeasureTime frameDescription
Incorporating the use of AI applications reduces the time required to block.During the procedure.This software finds the image, implements the block quickly, and spends less time.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026