ESP in Breast Surgery Due to Cancer

Medical University of Lublin

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Anesthesia, Local; Pain, Acute

Treatments: Procedure: General anesthesia; Procedure: Sham block; Drug: Oxycodone; Procedure: Patient-controlled analgesia; Drug: paracetamol; Procedure: Erector spinae plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT04726878

KE-0254/92/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective surgery of breast due to cancer
• obtained consent

Exclusion criteria

• the lack of consent
• the surgery of two breasts
• reoperation of the same breast
• previous participation in the study
• coagulopathy
• allergy to morphine and local anesthetics
• depression, antidepressant drugs treatment
• epilepsy
• usage of painkiller before surgery
• addiction to alcohol or recreational drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups, including a placebo group

Controlled

Placebo Comparator group

Description:

Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.

Treatment:

Procedure: Patient-controlled analgesia

Drug: Oxycodone

Drug: paracetamol

Procedure: General anesthesia

ESP block

Experimental group

Description:

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.375% ropivacaine will be performed. Then, the patient will be treated as in the controlled group.

Treatment:

Procedure: Erector spinae plane block

Procedure: Patient-controlled analgesia

Drug: Oxycodone

Drug: paracetamol

Procedure: General anesthesia

Sham block

Sham Comparator group

Description:

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.9% saline will be performed. Then, the patient will be treated as in the controlled group.

Treatment:

Procedure: Sham block

Procedure: Patient-controlled analgesia

Drug: Oxycodone

Drug: paracetamol

Procedure: General anesthesia