Comparison of The Effects Of General Anesthesia and PECS Block Methods on Blood Counts in Patients With Breast Cancer

Comparison of The Effects Of General Anesthesia and PECS Block Methods on Blood Leukocyte, Neutrophil, Lymphocyte, and Platelet Counts in Patients With Breast Cancer

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.

Study Overview

Detailed Description

For some solid tumors, surgical resection is the best approach available. Surgery causes the release of pro-inflammatory mediators and stimulation of the neuroendocrine system in the perioperative period. Additionally, surgery causes increased sympathetic stimulation and initiates a proinflammatory response to tissue damage. This pro-inflammatory response influences the cell-mediated immune response. Natural killer (NK) cells and CD8+ T cells both have antitumor activities and are associated with cortisol and catecholamine release. It also causes activation of pro-oncogenic cells, regulatory T cells, and type 2 helper T cells. This biological response to surgical stress may result in tumor cell survival and metastasis. Metastatic diseases are the most common cause of death in cancer patients. Exposure to anesthesia during surgery may also play a role in primary relapse or metastatic transformation. Agents used in the induction and maintenance of general anesthesia have interactions with the immune and neuroendocrine systems and may affect the stress response during surgery. Therefore, it is important to choose the best type of anesthesia that will help alleviate sympathetic and/or pro-inflammatory responses while modulating cytokine release and transcription factors/oncogenes. The effect of anesthesia may affect cancer cell survival and ability to metastasize, which can be stimulated not only during surgery but also during the immediate post-operative recovery phase. Studies on the effects of anesthesia methods and anesthetic drugs on tumor recurrence and metastasis are ongoing. It has been shown that volatile anesthetics such as sevoflurane and isoflurane may cause suppression of the immune system by blocking antigen-1-dependent integrin lymphocyte function. Non-volatile anesthetics such as ketamine have been shown to suppress Natural Killer (NK) cell cytotoxicity and inhibit the production of pro-inflammatory cytokines (IL-6 and TNF-α). It has been reported that opioids used alone in pain and pain treatment cause suppression of the immune system through NK activity. Regional anesthesia; It has been hypothesized that it may reduce cancer progression through different mechanisms, including modulation of the sympathetic response, avoidance of the harmful effects of general anesthetics and opioids, and direct immunomodulatory effects of local anesthetics. Peripheral nerve blocks are a regional anesthesia method used to reduce postoperative pain and opioid consumption in many primary tumor resections. In addition to the analgesic properties of local anesthetics and regional anesthesia methods used in regional anesthesia, their anti-inflammatory and antitumor effects have also been proven. The use of ultrasound (US) in peripheral nerve blocks for the last 10 years has increased the success rate in blocks and led to the discovery of new blocks. Fascial plane blocks (FPBs) are regional anesthesia techniques performed by needle insertion and injection into the space between two separate fascial layers. Analgesia is achieved by spreading local anesthetic to the nerves and adjacent tissues moving within this plane. In 2011, Rafael Blanco introduced a new method to analgesia methods after breast surgery by blocking the medial and lateral pectoral nerves of the brachial plexus between the pectoralis major and minor muscles (Pectoral Block I). Pectoral Block II was developed to be effective in axillary interventions. Ultrasound-guided Pectoral Block I and II (PECS I and II) are alternative methods to thoracic epidural and paravertebral blocks in preventing pain after breast surgery. In study, the investigators aimed to compare the effects of general anesthesia and peripheral nerve block (PECS Block) methods on the leukocyte, platelet-lymphocyte count and ratios, the total amount of opioids used, and discharge times in patients who underwent wire localized lumpectomy. It is aimed to ensure that the operation can be performed with peripheral nerve blocks, to protect the patient from immunosuppression that may be caused by general anesthetics and opioids, and to enable early discharge. The originality of the study is to investigate the usability of the PECS Block method not only as a postoperative pain method but also as an anesthesia method during surgery.

In addition, no clinical study has been found in the literature comparing the regional anesthesia method, which is applied only with local anesthetics, with the general anesthesia method.

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. PECS block was applied to patients who had a high risk of general anesthesia or who did not want to receive general anesthesia during the pandemic. Patients who could not reach a sufficient block level and required additional doses of analgesics were not included in the study. In the PECS I block, local anesthetic was applied between the fascia of the pectoralis major and minor muscles, and in the PECS II block, local anesthetic was applied between the fascia of the pectoralis minor and serratus muscles. The surgery duration, total analgesic amounts pre- and post-operative leukocyte, neutrophil, lymphocyte, platelet levels, and discharge times were evaluated from the records.

Study Type

Observational

Enrollment (Actual)

50

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

    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06200
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospita

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

N/A

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery under general anesthesia
13 patients were anesthetized intravenous with routine general anesthesia.
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 with Pecs block
13 patients underwent surgery with PECS block
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphocyte values
Time Frame: postoperative first day
difference in preoperative and postoperative lymphocyte values between the general anesthesia and PECS block groups
postoperative first day
neutrophil values
Time Frame: postoperative first day
difference in preoperative and postoperative neutrophil values between the general anesthesia and PECS block groups
postoperative first day
platelet values
Time Frame: postoperative first day
difference in preoperative and postoperative platelet values between the general anesthesia and PECS block groups
postoperative first day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative Neutrophil/Lymphocyte values
Time Frame: postoperative first day
diffrence in preoperative and postoperative Neutrophil/Lymphocyte ratios compared to preoperative values between the general anesthesia and PECS block groups
postoperative first day
postoperative platelet/lymphocyte ratios
Time Frame: postoperative first day
difference in preoperative and postoperative platelet/lymphocyte ratios compared to preoperative values between the general anesthesia and PECS block groups
postoperative first day
The discharge time
Time Frame: postoperative first day
The discharge time of patients between the general anesthesia and PECS block groups
postoperative first day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
total opioid consumption
Time Frame: intraoperative
difference between the general anesthesia and PECS block groups
intraoperative

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Guldeniz ARGUN, Dr. Abdurrahman Yurtaslan Oncology Train and Research Hospita

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)

August 1, 2022

Primary Completion (Actual)

January 10, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

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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