Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anesthesia Local
  • Breast Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a single-centre, prospective; double blinded randomised interventional clinical trial. Patients will be randomly allocated to group "PECS" or "ESP" using a closed envelope technique. Group "PECS" will receive PECS II block as described by Blanco using 30 ml Levobupivacaine 0.25% Group "ESP" will receive ESP block as described by forero using 30 ml Levobupivacaine 0.25% at T5 level. Blocks will be executed after general anesthesia induction. All partecipants will receive Fentanyl 2 mcg/kg and Propofol 2 mg/kg for induction. Anesthesia will be mantained with Propofol to obtain a BIS level between 40-50. Patients will receive Fentanyl 33 mcg whenever blood pressure and/or hear rate raise more than 20% from baseline after surgical stimulation. At the end of the surgery patients will receive acetominophen 1 g. postoperative therapy: acetominophen 1g/8hr and ketoprofen 100 mg/12hr. Patients will receive 2 mg Morphine whenever a NRS > 3.Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: ESP block and PECS block will be executed by an anesthesiologist that will not follow the patient during the surgery. Anesthesiologist responsible for the surgery will be not aware of the block executed on the patient Anesthesiologist and surgeon responsible for postoperative therapy will be not aware of the block executed on the patientPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Description

Not Provided

Not Provided

Tracking Information

NCT #
NCT03811262
Collaborators
Not Provided
Investigators
Principal Investigator: Alessandro De Cassai, MD Department of Medicine, DIMED - Section of Anesthesiology and Intensive Care. University of Padova