Clinical trial
The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks
Name
2170-29-02/1-2
Description
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.
Trial arms
Trial start
2023-04-01
Estimated PCD
2025-05-01
Trial end
2025-12-01
Status
Not yet recruiting
Treatment
Paravertebral nerve block (PVB)
PVB is a regional anesthetic technique applied at the thoracic (Th) level of Th2, Th3, and Th4 at a dose of 0.3ml/kg 0.5% levobupivacaine total, divided into levels. Block will be performed with ultrasound-guided in-plane technique and neurostimulation.
Arms:
Group 1 PVB
Pectoralis and Serratus Plane Nerve Blocks (PECS 2)
Pectoralis and Serratus Plane Nerve blocks (PECS 2) is a regional anesthetic technique applied in the space between the large and small pectoral muscles (10 ml of 0.5% levobupivacaine), and in the space between the small pectoralis muscle and the serratus anterior muscle (with 15 ml of 0.5% levobupivacaine). Block will be performed with ultrasound-guided in-plane technique and neurostimulation.
Arms:
Group 2 PECS
Regional anesthetic technique with ultrasound guidance
The device that will be used is an ultrasound with an 8 Hz ultrasonic linear probe for both regional anesthetic techniques.
Arms:
Group 1 PVB, Group 2 PECS
Regional anesthetic technique with peripheral nerve stimulation.
The 22G neurostimulator needle (Stimuplex D®, B. Braun Melsungen AG)\], and neurostimulator (Stimuplex HNS 12, B. Braun, Melsungen AG, Germany) will be used for both regional anesthesias.
Arms:
Group 1 PVB, Group 2 PECS
Levobupivacaine 0.5%
Local anesthetic levobupivacaine 0.5% will be used for regional anesthetic technique with ultrasound guidance and peripheral nerve stimulation. For the paravertebral block at a dose of 0.3ml/kg total, applied at the thoracic (Th) level of Th2, Th3, and Th4 and divided into levels. For the PECS 2 block levobupivacaine 0.5% 10 ml will be applied in the space between the large and small pectoral muscles and 15 ml in the space between the small pectoralis muscle and the serratus anterior muscle.
Arms:
Group 1 PVB, Group 2 PECS
General anesthesia
In both groups for induction of general anesthesia we will use 1% propofol 2 - 2.5 mg/kg (10 mg/ml, Fresenius), sufentanil (Sufentanil® Altamedics) 0.2 μg / kg, rocuronium \[Zemuron®, Schering - Plow\] 0.8 mg/kg. We will use a laryngeal mask (I - gel supraglottic airway) of appropriate sizes for airway maintenance. All subjects will be ventilated by controlled mechanical ventilation with a volume of 8 ml/kg, a frequency of about 12 breaths per min with a mixture of oxygen and air in a 40: 60% ratio. Maintenance of anesthesia and sedation in group 1 will be performed with continuous infusion of 1% propofol (10 mg / ml, Fresenius) (25 - 150 mcg / kg / min.) and rocuronium \[Zemuron®, Schering - Plow\] 0.01 mg / kg / min per perfusor.
Arms:
Group 1 PVB, Group 2 PECS
Size
100
Primary endpoint
Change in measured serum cytokines using an ELISA test after PVB.
1 hour before intervention to 48 hours after surgery
Change in measured serum cytokines using an ELISA test after PECS 2 block.
1 hour before intervention to 48 hours after surgery
Change in cell number of individual lymphocyte subpopulations determined by flow cytometry technique (FACSCalibur) after PVB application.
1 hour before intervention to 48 hours after surgery
Change in cell number of individual lymphocyte subpopulations determined by flow cytometry technique (FACSCalibur) after PECS 2 block application.
1 hour before intervention to 48 hours after surgery
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-04-18
1 organization
1 product
5 indications
Organization
University of RijekaProduct
LevobupivacaineIndication
Paravertebral BlockIndication
Breast CancerIndication
ImmunosuppressionIndication
Levobupivacaine