The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks

Summary

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.

Conditions

• Paravertebral Block
• Pectoralis and Serratus Plane Nerve Blocks
• Breast Cancer
• Immunologic Suppression
• Levobupivacaine

Interventions

PROCEDURE

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.

PROCEDURE

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.

DEVICE

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.

DEVICE

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.

DRUG

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.

PROCEDURE

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.

Sponsors & Collaborators

• University of Rijeka

  lead OTHER

Principal Investigators

• Ivan Ivanovski, M.D. · Faculty of Medicine, University of Rijeka

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-18

Primary Completion

2025-05-31

Completion

2025-12-31

Countries

• Croatia

Study Locations