Breast Cancer Clinical Trial
Official title:
The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks
The use of regional anesthesia in breast surgery improves the postoperative outcome, reduces the development of infection, and weakens the perioperative immunosuppressive response associated with the response to surgical stress. The investigators hypothesize that the use of propofol / paravertebral anesthesia and analgesia will be accompanied by a decrease in serum proinflammatory cytokines and/or an increase in anti-inflammatory cytokines compared to propofol / PECS 2 anesthesia and analgesia. The research will be on 100 respondents divided into two groups. 0.5% levobupivacaine will be administered to both groups. Serum concentrations of pro- and anti-inflammatory cytokines, and lymphocyte subpopulations 1h before, 24h, and 48h after surgery will be measured. The investigators aim to compare the effect of propofol / paravertebral and propofol / PECS 2 anesthesia and analgesia on serum perioperative values of pro-inflammatory and anti-inflammatory cytokines to standardize protocols and apply the best method of perioperative analgesia in breast cancer surgery.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - quadrantectomy with equilateral axillary lymphadenectomy - anesthesia preoperative status (American Society of Anesthesiologists (ASA)) 1 and 2 Exclusion Criteria: - patient rejection - ASA> 3 - contraindication for local anesthetic - contraindications for planned regional anesthesia and analgesia - immunosuppressive therapy including corticosteroids - acute infection - history of chronic opioid use - presence of autoimmune disease - obese definite body mass index BMI) greater than 29.9 kg/m2 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Rijeka |
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in measured serum cytokines using an ELISA test after PVB. | Venous blood samples will be collected 1 hour before and 24 and 48 hours after surgery. Serum concentrations in picogram per milliliter of pro-inflammatory cytokines Il-1, Il-6, TNFa, and anti-inflammatory cytokine IL-10 will be analyzed using an ELISA test according to the manufacturer's instructions. | 1 hour before intervention to 48 hours after surgery | |
Primary | Change in measured serum cytokines using an ELISA test after PECS 2 block. | Venous blood samples will be collected 1 hour before and 24 and 48 hours after surgery. Serum concentrations picogram per milliliter of pro-inflammatory cytokines Il-1, Il-6, TNFa, and anti-inflammatory cytokine IL-10 will be analyzed using an ELISA test according to the manufacturer's instructions. | 1 hour before intervention to 48 hours after surgery | |
Primary | Change in cell number of individual lymphocyte subpopulations determined by flow cytometry technique (FACSCalibur) after PVB application. | Venous blood samples will be collected 1 hour before and 24 and 48 hours after surgery. Peripheral blood leukocytes (PBL) will be isolated using a fluorescence-activated single-cell sorting flow cytometry technique on the FACSCalibur Flow Cytometer machine. Flow cytometry is a laser-based technique that detects and analyzes the chemical and physical characteristics of cells or particles. Individual lymphocyte subpopulations: T lymphocytes (helper and cytotoxic), B lymphocytes, NK, Treg (FITC-CD4, APC-CD25, and PE-Foxp3 positive), and NKT cells will be analyzed and determined according to the manufacturer's instructions using specific cell marker antibodies. After gating density plots the results will be presented in the number of cells in a cubic millimeter of blood and compared using scatter graphs. | 1 hour before intervention to 48 hours after surgery | |
Primary | Change in cell number of individual lymphocyte subpopulations determined by flow cytometry technique (FACSCalibur) after PECS 2 block application. | Venous blood samples will be collected 1 hour before and 24 and 48 hours after surgery. Peripheral blood leukocytes (PBL) will be isolated using a fluorescence-activated single-cell sorting flow cytometry technique on the FACSCalibur Flow Cytometer machine. Flow cytometry is a laser-based technique that detects and analyzes the chemical and physical characteristics of cells or particles. Individual lymphocyte subpopulations: T lymphocytes (helper and cytotoxic), B lymphocytes, NK, Treg (FITC-CD4, APC-CD25, and PE-Foxp3 positive), and NKT cells will be analyzed and determined according to the manufacturer's instructions using specific cell marker antibodies. After gating density plots the results will be presented in the number of cells in a cubic millimeter of blood and compared using scatter graphs. | 1 hour before intervention to 48 hours after surgery | |
Secondary | Duration of postoperative analgesia after PVB application measured using visual analgesic scale (VAS). | Postoperatively the subjects will be monitored in a post-anesthesia care unit (PACU) room where visual analgesic scale (VAS) [from 0 (no pain) to 10 (worst imaginable pain) according to Rawal will be notified at arrival to PACU, 1 hour and 2 hours postoperatively. Then the participants will be transferred to the department where, during the first 24 hours, the VAS will be assessed every 3 hours. | 24 postoperative hours | |
Secondary | Duration of postoperative analgesia after PECS 2 block application measured using visual analgesic scale (VAS). | Postoperatively the subjects will be monitored in a post-anesthesia care unit (PACU) room where visual analgesic scale (VAS) [from 0 (no pain) to 10 (worst imaginable pain) according to Rawal will be notified at arrival to PACU, 1 hour and 2 hours postoperatively. Then the participants will be transferred to the department where, during the first 24 hours, the VAS will be assessed every 3 hours. | 24 postoperative hours | |
Secondary | The total dosage of analgesics in the postoperative period after the PVB application. | The investigators will measure the total dosage of non-steroidal anti-inflammatory drugs (in mg) or opioid (in mg) analgesics in the first 48 hours after the PVB application. | 48 postoperative hours | |
Secondary | The total dosage of analgesics in the postoperative period after the PECS 2 block application. | The investigators will measure the total dosage of non-steroidal anti-inflammatory drugs (in mg) or opioid (in mg) analgesics in the first 48 hours after the PECS 2 application. | 48 postoperative hours | |
Secondary | Mean atrial pressure change after the PVB. | Before induction, mean arterial pressure (in mmHg) will be recorded using standard perioperative noninvasive blood pressure measurements at the time of block application, 60 min after, and at the time of transfer to the operating room. After induction, mean arterial pressure values will be recorded every five minutes for the duration of the operation. Postoperatively, subjects will be monitored in a post-anesthesia room where mean arterial pressure will be monitored at arrival, 1 hour and 2 hours postoperatively. | From time of intervention to 2 hours postoperatively | |
Secondary | Mean atrial pressure change after the PECS 2 block. | Before induction, mean arterial pressure (in mmHg) will be recorded using standard perioperative noninvasive blood pressure measurements at the time of block application, 60 min after, and at the time of transfer to the operating room. After induction, mean arterial pressure values will be recorded every five minutes for the duration of the operation. Postoperatively, subjects will be monitored in a post-anesthesia room where mean arterial pressure will be monitored at arrival, 1 hour and 2 hours postoperatively. | From time of intervention to 2 hours postoperatively | |
Secondary | Change in the volume compensation of colloids after the PVB. | Total preoperative crystalloids infusions in milliliters will be recorded at the time of transfer to the operating room. Total intraoperative colloid infusions will be recorded at the end of the operation, before transfer to the PACU. Total postoperative crystalloids infusions will be recorded in PACU at the transfer to the department and after the first 24 hours at the department. The investigators will compare the difference between the two groups. | From the time of intervention to 24 hours postoperatively | |
Secondary | Change in the volume compensation of colloids after the PECS2 block. | Total preoperative colloid infusions in milliliters will be recorded at the time of transfer to the operating room. Total intraoperative colloid infusions will be recorded at the end of the operation, before transfer to the PACU. Total postoperative colloid infusions will be recorded in PACU at the transfer to the department and after the first 24h at the department. The investigators will compare the difference between the two groups. | From the time of intervention to 24 hours postoperatively | |
Secondary | Changes in heart rate values after the PVB. | Before induction heart rate (in beats per minute) will be recorded using standard perioperative ECG monitoring at the time of block application, 60 min after, and at the time of transfer to the operating room. After induction, heart rate values will be recorded every five minutes for the duration of the operation. Postoperatively, subjects will be monitored in a post-anesthesia room where heart rate will be monitored at arrival, 1 hour and 2 hours postoperatively. | From the time of intervention to 2 hours postoperatively | |
Secondary | Changes in heart rate values after the PECS 2 block. | Before induction heart rate (in beats per minute) will be recorded standard perioperative ECG monitoring at the time of block application, 60 min after, and at the time of transfer to the operating room. After induction, heart rate values will be recorded every five minutes for the duration of the operation. Postoperatively, subjects will be monitored in a post-anesthesia room where heart rate will be monitored at arrival, 1 hour and 2 hours postoperatively. | From the time of intervention to 2 hours postoperatively | |
Secondary | Change in the perioperative need for vasoactive drugs after PVB. | Total perioperative vasoactive drug applications in milligrams will be recorded at the end of the operation and before the transfer to the department. The investigators will compare the difference between the two groups in vasoactive drug application. | From the time of intervention to 2 hours postoperatively | |
Secondary | Change in the perioperative need for vasoactive drugs after PECS 2 block. | Total perioperative vasoactive drug applications in milligrams will be recorded at the end of the operation and before the transfer to the department. The investigators will compare the difference between the two groups in vasoactive drug application. | From the time of intervention to 2 hours postoperatively |
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