Clinical trial · Interventional
The Immune Response of Breast Cancer Patients Treated With Levobupivacaine Using Paravertebral or Superficial Chest Blocks
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Immunologic Suppression | — | UNRESOLVED | — |
| Levobupivacaine | — | UNRESOLVED | — |
| Paravertebral Block | — | UNRESOLVED | — |
| Pectoralis and Serratus Plane Nerve Blocks | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Procedure | — | UNRESOLVED |
| Levobupivacaine 0.5% | Drug | — | UNRESOLVED |
| Paravertebral nerve block (PVB) | Procedure | — | UNRESOLVED |
| Pectoralis and Serratus Plane Nerve Blocks (PECS 2) | Procedure | — | UNRESOLVED |
| Regional anesthetic technique with peripheral nerve stimulation. | Device | — | UNRESOLVED |
| Regional anesthetic technique with ultrasound guidance | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1 PVB
- description
- Group 1 will receive paravertebral block (PVB) as analgesia for breast surgery. 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.
- interventionNames
- Procedure: Paravertebral nerve block (PVB)
- Device: Regional anesthetic technique with ultrasound guidance
- Device: Regional anesthetic technique with peripheral nerve stimulation.
- Drug: Levobupivacaine 0.5%
- Procedure: General anesthesia
- type
- EXPERIMENTAL
- label
- Group 2 PECS
- description
- Group 2 will receive Pectoralis and Serratus Plane Nerve blocks (PECS 2) as analgesia for breast surgery. PECS 2 block 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (21)
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- BACKGROUNDDeegan CA, Murray D, Doran P, Moriarty DC, Sessler DI, Mascha E, Kavanagh BP, Buggy DJ. Anesthetic technique and the cytokine and matrix metalloproteinase response to primary breast cancer surgery. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):490-5. doi: 10.1097/AAP.0b013e3181ef4d05. PMID 20975461
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