Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

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.

Conditions

• Breast Cancer Female

Interventions

DRUG

Midazolam

1-2 mg of Midazolam as premedication.

PROCEDURE

PECS

Loco-regional anesthesia: PEC I and serratus plane block with an echoguided technique. For the PEC I: infiltration of 10 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of the pectoralis major muscle and the small pectoralis muscle at the height of the third rib on the anterior axillary line. For the serratus plane block: identification of the fifth rib on the average axillary line and infusion of about 20 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of large dorsal muscle and of the anterior serratus muscle.

PROCEDURE

Opioid-free general anesthesia

Induction with Propofol 1.5-2 mg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in Target-Controlled Infusion (TCI) of 6 mcg/ml, subsequently modified to maintain a Bispectral Index (BIS) value between 40 and 60. Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase \>20%. In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.

PROCEDURE

General anesthesia

Induction with Propofol 1.5-2 mg/kg; Fentanyl 1μg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in TCI of 6 mcg/ml, subsequently modified to maintain a BIS value between 40 and 60. Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase \>20%. In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer.

PROCEDURE

Postoperative analgesia

Paracetamol 1000 mg every 8 hours for the first 24 hours, Ketorolac 30 mg in case of pain control failure (Numeric Rating Scale- NRS\>4) which can be administered every 8 hours at most (max 90 mg / 24 hours), Morphine 10-20 mg IV in 24 hours as rescue analgesia.

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano

  lead OTHER

Principal Investigators

• Fabrizio Brescia, MD · Centro di Riferimento Oncologico di Aviano (CRO), IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-31

Primary Completion

2021-11-01

Completion

2022-11-01

Countries

• Italy

Study Locations