Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

Centro di Riferimento Oncologico - Aviano

Status: Completed

Conditions: Breast Cancer Female

Treatments: Procedure: General anesthesia; Drug: Midazolam; Procedure: Postoperative analgesia; Procedure: Opioid-free general anesthesia; Procedure: PECS

Study type: Interventional

Funder types: Other

Identifiers

NCT04172220

CRO-2019-26

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

PECS + Opioid-free GA

Experimental group

Description:

Loco-regional anesthesia with PEC I and serratus plane block with an echoguided technique and opioid-free general anesthesia

Treatment:

Procedure: PECS

Procedure: Opioid-free general anesthesia

Procedure: Postoperative analgesia

Drug: Midazolam

GA

Active Comparator group

Description:

General anesthesia

Treatment:

Procedure: Postoperative analgesia

Procedure: General anesthesia

Drug: Midazolam