Clinical trial · Interventional
Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?
Variation of the Neutrophil To Lymphocyte Ratio During Opioid-Free General Anesthesia Associated With Thoracic Wall Blocks Vs General Anesthesia, in Breast Cancer Quadrantectomy: a Randomized Controlled Trial
- 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 Neutrophil to Lymphocyte Ratio (NLR) is a frequently used biomarker of the systemic inflammatory response and is considered one of the most sensitive markers of inflammation. Many studies have documented the association between the use of opioid drugs in the acute phase -as it can be considered the use during general anesthesia- and the increase of the NLR value. Such increase could determine a temporary phase of immunodepression in the immediate post operative period with consequent increase of the inflammatory state. This study intends to assess whether different anesthetic techniques can be associated with different variations of the intra-patient NLR value between pre- and post-surgery. Patient will be randomized to receive either local regional anesthesia protocols with thoracic wall blocks (PEC I and serratus plane block) associated with opioid-free general anesthesia (PECS + Opioid-free GA) or general anesthesia.
Conditions
Conditions (1)
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 Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General anesthesia | Procedure | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Opioid-free general anesthesia | Procedure | — | UNRESOLVED |
| PECS | Procedure | — | UNRESOLVED |
| Postoperative analgesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PECS + Opioid-free GA
- description
- Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia
- interventionNames
- Drug: Midazolam
- Procedure: PECS
- Procedure: Opioid-free general anesthesia
- Procedure: Postoperative analgesia
- type
- ACTIVE_COMPARATOR
- label
- GA
- description
- General anesthesia
- interventionNames
- Drug: Midazolam
- Procedure: General anesthesia
- Procedure: Postoperative analgesia
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * First diagnosis of histologically confirmed breast cancer * Candidate to external quadrantectomy and axillary surgery (biopsy of the sentinel lymph node and possible axillary lymphadenectomy) * Able to provide adequate informed consent * With intact cognitive abilities Exclusion Criteria: * Ongoing pregnancy * In therapy or in follow-up for other cancers at the time of the study * Concurrent therapy with opioids or other drugs, for chronic pain conditions related to cancer or other diseases * History of documented allergy or previous adverse reaction to local anesthetics * Documented history of anesthesiology related problems during previous surgical interventions or history of problems in airway management * Unable to comply to study protocol schedule for logistic or other reasons * Refusal to participate to the study (absence of signed informed consent)
References
Publications (1)
- DERIVEDBrescia F, Favero A, Segatto I, Massarut S, Zanier C, Fabiani F, Nadalini E, Morabito A, Montico M, Zucchetto A, Zanussi S, Baldassarre G, Belletti B. Impact of opioid-free general anesthesia with locoregional blocks during breast cancer surgery on systemic inflammatory response: results from a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 25:rapm-2025-106504. doi: 10.1136/rapm-2025-106504. Online ahead of print. PMID 40562448