NCT06151639

Brief Summary

Regional anesthesia and local anesthetics have proven anti-inflammatory and antitumor effects as well as their analgesic properties. On this trial, the investigators are searching anesthetic techniques affect on the leukocyte, platelet-lymphocyte count and ratios, total amount of opioids used, and discharge times in patients who will undergo wire localized lumpectomy operation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

November 16, 2023

Last Update Submit

August 28, 2025

Conditions

Keywords

General AnesthesiaPECS blockNeutrophil-Lymphocyte ratioPlatelet-Lymphocyte ratio

Outcome Measures

Primary Outcomes (3)

  • lymphocyte values

    difference in preoperative and postoperative lymphocyte values between the general anesthesia and PECS block groups

    postoperative first day

  • neutrophil values

    difference in preoperative and postoperative neutrophil values between the general anesthesia and PECS block groups

    postoperative first day

  • platelet values

    difference in preoperative and postoperative platelet values between the general anesthesia and PECS block groups

    postoperative first day

Secondary Outcomes (3)

  • postoperative Neutrophil/Lymphocyte values

    postoperative first day

  • postoperative platelet/lymphocyte ratios

    postoperative first day

  • The discharge time

    postoperative first day

Other Outcomes (1)

  • total opioid consumption

    intraoperative

Study Arms (2)

Surgery under general anesthesia

13 patients were anesthetized intravenous with routine general anesthesia.

Procedure: general anesthesia

Surgery with Pecs block

13 patients underwent surgery with PECS block

Procedure: peripheral nerve blocks

Interventions

General anesthesia was performed by muscle relaxant(rocuronium 0,6 mg/kg), opioids(phentanyl 1-2 mcg/kg) and propofol 2mg/kg. Inhation anesthetics and remiphentanyl infusion were used for maintance general anesthesia.

Surgery under general anesthesia

With the help of ultrasonography, at the 2nd rib level, between the fasciae of the pectoralis major and minor muscles at the mid-clavicle level (PECS I block, interpectoral fascial plane block) and at the 4th rib level, at the mid-axillary level, between the fasciae of the pectoralis minor and serratus muscles (PECS II block, pectoroseratal fascial plane block) local anesthesia was applied. In patients who underwent PECS block, a high-frequency linear ultrasonography (Esaote, My LabFive-Genova, Italy) probe and a 50 mm tip insulated needle (echoplex+, Vygon Ecouen-France) were used. 0.200% bupivacaine 15 ml was applied for the PECS I block, and 0.200% bupivacaine 20 ml was applied for the PECS II block, and fascial separation was observed. Sensory control was performed in the breast and axilla area and the patients were taken into surgery.

Surgery with Pecs block

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was planned retrospectively. 50 patients who underwent wire localized lumpectomy for breast cancer treatment and diagnosis under general anesthesia (n=25) or PECS block (n=25) were found in hospital records.

You may qualify if:

  • Diagnosed with unilateral primary breast cancer
  • Are decided to undergo wire localized lumpectomy
  • Having a risk score of The American Society of Anaesthesiologists (ASA) risk score 1,2 and 3
  • Should be over18 years old

You may not qualify if:

  • Being allergic to the anesthetics
  • Opioid or steroid usage before the operation
  • Patients who could not reach a sufficient block level and required additional doses of analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospita

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (8)

  • Montejano J, Jevtovic-Todorovic V. Anesthesia and Cancer, Friend or Foe? A Narrative Review. Front Oncol. 2021 Dec 23;11:803266. doi: 10.3389/fonc.2021.803266. eCollection 2021.

    PMID: 35004329BACKGROUND
  • Coussens LM, Werb Z. Inflammation and cancer. Nature. 2002 Dec 19-26;420(6917):860-7. doi: 10.1038/nature01322.

    PMID: 12490959BACKGROUND
  • Weingart SN, Nelson J, Koethe B, Yaghi O, Dunning S, Feldman A, Kent D, Lipitz-Snyderman A. Association between cancer-specific adverse event triggers and mortality: A validation study. Cancer Med. 2020 Jun;9(12):4447-4459. doi: 10.1002/cam4.3033. Epub 2020 Apr 13.

    PMID: 32285614BACKGROUND
  • Forget P, Aguirre JA, Bencic I, Borgeat A, Cama A, Condron C, Eintrei C, Eroles P, Gupta A, Hales TG, Ionescu D, Johnson M, Kabata P, Kirac I, Ma D, Mokini Z, Guerrero Orriach JL, Retsky M, Sandrucci S, Siekmann W, Stefancic L, Votta-Vellis G, Connolly C, Buggy D. How Anesthetic, Analgesic and Other Non-Surgical Techniques During Cancer Surgery Might Affect Postoperative Oncologic Outcomes: A Summary of Current State of Evidence. Cancers (Basel). 2019 Apr 28;11(5):592. doi: 10.3390/cancers11050592.

    PMID: 31035321BACKGROUND
  • Deng F, Ouyang M, Wang X, Yao X, Chen Y, Tao T, Sun X, Xu L, Tang J, Zhao L. Differential role of intravenous anesthetics in colorectal cancer progression: implications for clinical application. Oncotarget. 2016 Nov 22;7(47):77087-77095. doi: 10.18632/oncotarget.12800.

    PMID: 27780923BACKGROUND
  • Gabriel RA, Swisher MW, Sztain JF, Furnish TJ, Ilfeld BM, Said ET. State of the art opioid-sparing strategies for post-operative pain in adult surgical patients. Expert Opin Pharmacother. 2019 Jun;20(8):949-961. doi: 10.1080/14656566.2019.1583743. Epub 2019 Feb 27.

    PMID: 30810425BACKGROUND
  • Bugada D, Lorini LF, Lavand'homme P. Opioid free anesthesia: evidence for short and long-term outcome. Minerva Anestesiol. 2021 Feb;87(2):230-237. doi: 10.23736/S0375-9393.20.14515-2. Epub 2020 Aug 4.

    PMID: 32755088BACKGROUND
  • Chong PH, Yeo ZZ. Parenteral Lidocaine for Complex Cancer Pain in the Home or Inpatient Hospice Setting: A Review and Synthesis of the Evidence. J Palliat Med. 2021 Aug;24(8):1154-1160. doi: 10.1089/jpm.2020.0622. Epub 2020 Dec 22.

    PMID: 33351710BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Guldeniz ARGUN

    Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospita

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr.

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 30, 2023

Study Start

August 1, 2022

Primary Completion

January 10, 2025

Study Completion

March 3, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations