Does Type of Anesthesia Influence Inflammation Change After Breast Surgery?

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

October 31, 2019

Primary Completion Date

November 1, 2021

Study Completion Date

November 1, 2022

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.

Trial Locations (1)

33081

Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, Aviano

All Listed Sponsors
lead

Centro di Riferimento Oncologico - Aviano

OTHER

NCT04172220 - Does Type of Anesthesia Influence Inflammation Change After Breast Surgery? | Biotech Hunter | Biotech Hunter