Clinical trial NCT06480045: Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies
Official title: Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: mastectomy
pectoral nerve block
USG
artificial intelligence
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain in the postoperative period was evaluated using the VAS score.
timeFrame: 24 hours
Secondary outcomes:
measure: Incorporating the use of AI applications reduces the time required to block.
timeFrame: During the procedure.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Çağla Yazar, MD
Study officials:
affiliation: Baskent University
name: Elvin Kesimci
role: STUDY_DIRECTOR
affiliation: Baskent University
name: Çağla Yazar
role: PRINCIPAL_INVESTIGATOR
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