At a glance
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NCT05816538N/AActiveUpdate OverdueUpdated 14mo ago · Completion was 14mo agoThe Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks
In Brief
A clinical study evaluating Paravertebral nerve block (PVB), Pectoralis and Serratus Plane Nerve Blocks (PECS 2), and 4 other interventions for Paravertebral Block and 4 related conditions. Active but no longer recruiting, targeting 100 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
The device that will be used is an ultrasound with an 8 Hz ultrasonic linear probe for both regional anesthetic techniques.
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.
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.
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.