ESP in Breast Surgery Due to Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

August 12, 2021

Study Completion Date

August 17, 2021

Conditions
Breast CancerPain, AcuteAnesthesia, Local
Interventions
PROCEDURE

Erector spinae plane block

Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).

PROCEDURE

Sham block

Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

PROCEDURE

General anesthesia

"Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium.~The maintenance with oxygen/air mixture, sevoflurane, and fentanyl."

PROCEDURE

Patient-controlled analgesia

All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)

DRUG

Oxycodone

Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40.

DRUG

paracetamol

intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

Trial Locations (1)

20-081

II Department of Anesthesia and Intensive Care, Medical University of Lublin, Lublin

All Listed Sponsors
lead

Medical University of Lublin

OTHER

NCT04726878 - ESP in Breast Surgery Due to Cancer | Biotech Hunter | Biotech Hunter