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

NCT06480045 | Completed

• 1 other identifier: KA21/353
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

mastectomy; pectoral nerve block; USG; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Pain in the postoperative period was evaluated using the VAS score.

  The 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.

  24 hours

Secondary Outcomes (1)

• Incorporating the use of AI applications reduces the time required to block.

  During the procedure.

Study Arms (2)

Group AI-USG

ACTIVE COMPARATOR

performed a PECS II block with AI-integrated USG

Procedure: Performed PECS II block with AI integrated USG

Group USG

ACTIVE COMPARATOR

performed a PECS II block with conventional USG

Procedure: Performed PECS II block with conventional USG

Interventions

Performed PECS II block with AI integrated USG PROCEDURE

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

Group AI-USG

Performed PECS II block with conventional USG PROCEDURE

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

Group USG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• ASA I and II
• Female
• Underwent mastectomy surgery
• Without local anesthetic allergy

You may not qualify if:

• 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

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Çağla Yazar, MD

Antalya, 07090, Turkey (Türkiye)

Location

Related Publications (35)

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elvin Kesimci

  Baskent University

  STUDY DIRECTOR

• Çağla Yazar

  Baskent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: June 28, 2024
• Study Start: November 5, 2021
• Primary Completion: February 5, 2023
• Study Completion: May 5, 2023
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)