Clinical trial NCT04172220: Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Breast Cancer
PECS
Neutrophil to Lymphocyte ratio
Quadrantectomy
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, open label randomised controlled trial
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 24h NLR variation
timeFrame: Pre-operative and at 24 hours after the end of surgery
Secondary outcomes:
measure: 1h NLR variation
timeFrame: Pre-operative, 1 hour and 24 hours after the end of surgery
measure: Opioid consumption
timeFrame: 24 hours
measure: Complication
timeFrame: until hospital discharge, an average of 48 hours
measure: Chronic pain
timeFrame: 3, 6 and 12 months after surgery
measure: Change in the levels of circulating cytokines in the post-operative period (one hour and 24 hours after surgery), compared to the baseline pre-operative values, in the two arms
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
state: PN
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO), IRCCS
name: Fabrizio Brescia, MD
role: PRINCIPAL_INVESTIGATOR
References: