Breast NeoplasmsNCT06480045

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

A study testing Performed PECS II block with AI integrated USG and Performed PECS II block with conventional USG in people with Breast Neoplasms, run by Baskent University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: Performed PECS II block with AI integrated USG and Performed PECS II block with conventional USG
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 5 Nov 2021to 5 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Çağla Yazar, MD
Antalya, 07090

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Conditions: Breast Neoplasms
Being tested: Performed PECS II block with AI integrated USG, Performed PECS II block with conventional USG
Keywords: mastectomy, pectoral nerve block, USG, artificial intelligence
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06480045
Study group	Role	What they receive
Group AI-USG	Active comparator	performed a PECS II block with AI-integrated USG Receives: Procedure: Performed PECS II block with AI integrated USG
Group USG	Active comparator	performed a PECS II block with conventional USG Receives: Procedure: Performed PECS II block with conventional USG

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 20215 May 2023

First posted28 Jun 2024
Study start5 Nov 2021
Primary completion5 Feb 2023
Study completion5 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06480045
Sponsor's protocol ID: KA21/353
Status last verified: Jun 2024
First submitted: 7 Dec 2023
Last updated: 28 Jun 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.
PubMed 31040712
Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
PubMed 25376971
Bartakke DAA, Varma DMK. Analgesia for breast surgery - A Brief Overview. Medicine. 2019;7.
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
PubMed 21831090
Bakeer AH, Kamel KM, Abdelgalil AS, Ghoneim AA, Abouel Soud AH, Hassan ME. Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy: A Randomized Controlled Trial. J Pain Res. 2020 Jul 14;13:1769-1775. doi: 10.2147/JPR.S252539. eCollection 2020.
PubMed 32765052
Karaca O, Pinar HU, Arpaci E, Dogan R, Cok OY, Ahiskalioglu A. The efficacy of ultrasound-guided type-I and type-II pectoral nerve blocks for postoperative analgesia after breast augmentation: A prospective, randomised study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):47-52. doi: 10.1016/j.accpm.2018.03.009. Epub 2018 Apr 5.
PubMed 29627431
la Grange P, Foster PA, Pretorius LK. Application of the Doppler ultrasound bloodflow detector in supraclavicular brachial plexus block. Br J Anaesth. 1978 Sep;50(9):965-7. doi: 10.1093/bja/50.9.965.
PubMed 708565
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
PubMed 22939099
Kuş A. Pektoral blok derleme. Türkiye Klinikleri Anesteziyoloji Reanimasyon - Özel Konular. 2015;8(3):74-7.
Sites BD, Chan VW, Neal JM, Weller R, Grau T, Koscielniak-Nielsen ZJ, Ivani G; American Society of Regional Anesthesia and Pain Medicine; European Society Of Regional Anaesthesia and Pain Therapy Joint Committee. The American Society of Regional Anesthesia and Pain Medicine and the European Society Of Regional Anaesthesia and Pain Therapy Joint Committee recommendations for education and training in ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):40-6. doi: 10.1097/AAP.0b013e3181926779.
PubMed 19258987
Akkus Z, Cai J, Boonrod A, Zeinoddini A, Weston AD, Philbrick KA, Erickson BJ. A Survey of Deep-Learning Applications in Ultrasound: Artificial Intelligence-Powered Ultrasound for Improving Clinical Workflow. J Am Coll Radiol. 2019 Sep;16(9 Pt B):1318-1328. doi: 10.1016/j.jacr.2019.06.004.
PubMed 31492410
Bowness J, Varsou O, Turbitt L, Burkett-St Laurent D. Identifying anatomical structures on ultrasound: assistive artificial intelligence in ultrasound-guided regional anesthesia. Clin Anat. 2021 Jul;34(5):802-809. doi: 10.1002/ca.23742. Epub 2021 May 11.
PubMed 33904628
Gungor I, Gunaydin B, Oktar SO, M Buyukgebiz B, Bagcaz S, Ozdemir MG, Inan G. A real-time anatomy identification via tool based on artificial intelligence for ultrasound-guided peripheral nerve block procedures: an accuracy study. J Anesth. 2021 Aug;35(4):591-594. doi: 10.1007/s00540-021-02947-3. Epub 2021 May 19.
PubMed 34008072
Bowness J, El-Boghdadly K, Burckett-St Laurent D. Artificial intelligence for image interpretation in ultrasound-guided regional anaesthesia. Anaesthesia. 2021 May;76(5):602-607. doi: 10.1111/anae.15212. Epub 2020 Jul 29. No abstract available.
PubMed 32726498
FitzGerald S, Odor PM, Barron A, Pawa A. Breast surgery and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):95-110. doi: 10.1016/j.bpa.2019.03.003. Epub 2019 Apr 6.
PubMed 31272657

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies
ClinicalTrials.gov ID: NCT06480045
Acronym / sponsor ID: KA21/353
Conditions: Breast Neoplasms
Keywords: mastectomy, pectoral nerve block, USG, artificial intelligence
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Baskent UniversityUniversity, hospital or other
Study start: 5 Nov 2021 (actual)
Primary completion: 5 Feb 2023 (actual)
Study completion: 5 May 2023 (actual)
First posted: 28 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group AI-USG	Active comparator	Procedure: Performed PECS II block with AI integrated USGperformed a PECS II block with AI-integrated USG
Group USG	Active comparator	Procedure: Performed PECS II block with conventional USGperformed a PECS II block with conventional USG

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Patients with ASA III and above
Obesity (body mass index >30)
Psychotropic drug use
Bleeding diathesis
Local anesthetic allergy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Performed PECS II block with AI integrated USGA 4-year anesthesiology resident, under the supervision of two senior anesthesiologists, performed a PECS II block with AI-integrated USG.	Procedure or surgery	Group AI-USG
Performed PECS II block with conventional USGA 4-year anesthesiology resident, under the supervision of two senior anesthesiologists, performed a PECS II block with conventional USG.	Procedure or surgery	Group USG

Primary outcome

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.

1 secondary outcome

Incorporating the use of AI applications reduces the time required to block.
Time frame: During the procedure.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
Background: PubMed 31040712Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.
Background: PubMed 25376971Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
BackgroundBartakke DAA, Varma DMK. Analgesia for breast surgery - A Brief Overview. Medicine. 2019;7.
Background: PubMed 21831090Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Background: PubMed 32765052Bakeer AH, Kamel KM, Abdelgalil AS, Ghoneim AA, Abouel Soud AH, Hassan ME. Modified Pectoral Nerve Block versus Serratus Block for Analgesia Following Modified Radical Mastectomy: A Randomized Controlled Trial. J Pain Res. 2020 Jul 14;13:1769-1775. doi: 10.2147/JPR.S252539. eCollection 2020.
Background: PubMed 29627431Karaca O, Pinar HU, Arpaci E, Dogan R, Cok OY, Ahiskalioglu A. The efficacy of ultrasound-guided type-I and type-II pectoral nerve blocks for postoperative analgesia after breast augmentation: A prospective, randomised study. Anaesth Crit Care Pain Med. 2019 Feb;38(1):47-52. doi: 10.1016/j.accpm.2018.03.009. Epub 2018 Apr 5.
Background: PubMed 708565la Grange P, Foster PA, Pretorius LK. Application of the Doppler ultrasound bloodflow detector in supraclavicular brachial plexus block. Br J Anaesth. 1978 Sep;50(9):965-7. doi: 10.1093/bja/50.9.965.
Background: PubMed 22939099Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
BackgroundKuş A. Pektoral blok derleme. Türkiye Klinikleri Anesteziyoloji Reanimasyon - Özel Konular. 2015;8(3):74-7.
Background: PubMed 19258987Sites BD, Chan VW, Neal JM, Weller R, Grau T, Koscielniak-Nielsen ZJ, Ivani G; American Society of Regional Anesthesia and Pain Medicine; European Society Of Regional Anaesthesia and Pain Therapy Joint Committee. The American Society of Regional Anesthesia and Pain Medicine and the European Society Of Regional Anaesthesia and Pain Therapy Joint Committee recommendations for education and training in ultrasound-guided regional anesthesia. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):40-6. doi: 10.1097/AAP.0b013e3181926779.
Background: PubMed 31492410Akkus Z, Cai J, Boonrod A, Zeinoddini A, Weston AD, Philbrick KA, Erickson BJ. A Survey of Deep-Learning Applications in Ultrasound: Artificial Intelligence-Powered Ultrasound for Improving Clinical Workflow. J Am Coll Radiol. 2019 Sep;16(9 Pt B):1318-1328. doi: 10.1016/j.jacr.2019.06.004.
Background: PubMed 33904628Bowness J, Varsou O, Turbitt L, Burkett-St Laurent D. Identifying anatomical structures on ultrasound: assistive artificial intelligence in ultrasound-guided regional anesthesia. Clin Anat. 2021 Jul;34(5):802-809. doi: 10.1002/ca.23742. Epub 2021 May 11.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elvin Kesimci study director

Baskent University

Çağla Yazar principal investigator

Baskent University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain in the postoperative period was evaluated using the VAS score. (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06480045, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.