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

NAActive, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 18, 2024

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2025

Conditions
Paravertebral BlockPectoralis and Serratus Plane Nerve BlocksBreast CancerImmunologic SuppressionLevobupivacaine
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.

Trial Locations (1)

51000

University hospital centre Rijeka, Rijeka

All Listed Sponsors
lead

University of Rijeka

OTHER

NCT05816538 - The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks | Biotech Hunter | Biotech Hunter