Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151639
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2023-11-16
Brief Title:
Comparison of The Effects Of General Anesthesia and PECS Block Methods on Blood Counts in Patients With Breast Cancer
Sponsor:
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Organization:
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Study Overview
Official Title:
Comparison of The Effects Of General Anesthesia and PECS Block Methods on Blood Leukocyte Neutrophil Lymphocyte and Platelet Counts in Patients With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 andor pro-inflammatory responses while modulating cytokine release and transcription factorsoncogenes 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 26 patients who underwent wire localized lumpectomy for breast cancer treatment and diagnosis under general anesthesia n13 or PECS block n13 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
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 26 patients who underwent wire localized lumpectomy for breast cancer treatment and diagnosis under general anesthesia n13 or PECS block n13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None