ESP in Breast Surgery Due to Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer

Conditions
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Breast Cancer, Pain, Acute, Anesthesia, Local

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: Sham block
* Procedure: General anesthesia
* Procedure: Patient-controlled analgesia
* Drug: Oxycodone
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Controlled<br>Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone. | Procedure: General anesthesia<br>* 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.<br>* Other names: GA;Procedure: Patient-controlled analgesia<br>* All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)<br>* Other names: PCA;Drug: Oxycodone<br>* 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.<br>Drug: paracetamol<br>* intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>|
| Experimental: ESP block<br>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. | Procedure: Erector spinae plane block<br>* Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).<br>* Other names: ESP block;Procedure: General anesthesia<br>* 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.<br>* Other names: GA;Procedure: Patient-controlled analgesia<br>* All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)<br>* Other names: PCA;Drug: Oxycodone<br>* 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.<br>Drug: paracetamol<br>* intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>|
| Sham Comparator: Sham block<br>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. | Procedure: Sham block<br>* Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).<br>Procedure: General anesthesia<br>* 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.<br>* Other names: GA;Procedure: Patient-controlled analgesia<br>* All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)<br>* Other names: PCA;Drug: Oxycodone<br>* 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.<br>Drug: paracetamol<br>* intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery 40 | Quality of recovery (QoR) score containing 40 items. This questionnaire measures the early postoperative health status of patients. Minimum is 40, maximum is 200. More points is better. | Before the hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-controlled analgesia (PCA) | All good and bad demands with PCA pump. | 24 hours from the connection of the PCA pump in the post-anesthesia care unit. | 
| Visual analog scale | Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse. | up to 24 hours after the surgery | 
| Total oxycodone consumption | Consumption of oxycodone with PCA pump, loading, and additional doses. | up to 24 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block, visual analog scale, quality of recovery, patient-controlled analgesia