ESP in Breast Surgery Due to Cancer
Condition: Breast Cancer; Pain, Acute; Anesthesia, Local
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled for breast surgery due to cancer. Each patient will be treated with
      intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated
      to one of three groups: erector spinae plane (ESP) block, sham block, controlled group.
    

Detailed description: 
      Only patients who are qualified for an elective procedure of mitral breast surgery may
      participate in the study. Each patient will be anesthetized generally. The same drugs will be
      used in each stage of anesthesia. The induction: propofol, fentanyl, rocuronium. The airway
      will be secured with a laryngeal mask airway (LMA). When there is a risk of aspiration, the
      patient will be intubated. Then, rocuronium or suxamethonium will be used. The anesthesia
      maintenance: sevoflurane, fentanyl. The emergence: oxygen, sugammadex or neostigmine a
      required.

      After the induction of general anesthesia, an opaque envelope with the selected group will be
      opened. In the controlled group, the procedure will be continued in the patient's supine
      position. Women from the ESP and Sham groups will be placed in the lateral position. The
      operated side will be above. Then, the ultrasound-guided ESP block with saline or ropivacaine
      will be performed.

      At the end of the surgery, an anesthesiologist will administer oxycodone intravenously (0.1
      mg/KG).

      After emergence from anesthesia, the patient will be transferred to the postoperative care
      unit. Vital signs will be monitored. The patient-controlled analgesia pump with oxycodone
      will be used.
    

Intervention name(s): Erector spinae plane block; Sham block; General anesthesia; Patient-controlled analgesia; Oxycodone; paracetamol
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Drug; Drug
Intervention description(s): Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).; Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).; 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.; All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit); 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.; intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
Other intervention name(s): ESP block; GA; PCA
Intervention MeSH terms: Acetaminophen; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized 1:1:1
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: erector spinae plane block; visual analog scale; quality of recovery; patient-controlled analgesia