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

June 27, 2024 updated by: Çağla Yazar, MD, Baskent University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07090
        • Çağla Yazar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group AI-USG
performed a PECS II block with AI-integrated USG
Procedure: Performed 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.
Active Comparator: Group USG
performed a PECS II block with conventional USG
Procedure: Performed 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in the postoperative period was evaluated using the VAS score.
Time Frame: 24 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incorporating the use of AI applications reduces the time required to block.
Time Frame: During the procedure.
This software finds the image, implements the block quickly, and spends less time.
During the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Study Director: Elvin Kesimci, Baskent University
  • Principal Investigator: Çağla Yazar, Baskent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Actual)

February 5, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA21/353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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