NCT04172220

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Centro di Riferimento Oncologico - Aviano · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-31
• Primary completion: 2021-11-01
• Completion: 2022-11-01
• First posted: 2019-11-21
• Last updated: 2024-10-16

Locations

1 site across 1 country: Italy