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

NCT ID: NCT06480045

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2023-05-05

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Keywords

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mastectomy pectoral nerve block USG artificial intelligence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group AI-USG

performed a PECS II block with AI-integrated USG

Group Type ACTIVE_COMPARATOR

Performed PECS II block with AI integrated USG

Intervention Type PROCEDURE

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

Group USG

performed a PECS II block with conventional USG

Group Type ACTIVE_COMPARATOR

Performed PECS II block with conventional USG

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Çağla Yazar, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elvin Kesimci

Role: STUDY_DIRECTOR

Baskent University

Çağla Yazar

Role: PRINCIPAL_INVESTIGATOR

Baskent University

Locations

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Çağla Yazar, MD

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Other Identifiers

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KA21/353

Identifier Type: -

Identifier Source: org_study_id