Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Quality of recovery 40
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient: The primary intervention (erector spinae plane block) will be provided under general anesthesia.
The investigator and outcome assessor will be not aware of the allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective surgery of breast due to cancer
- •obtained consent
排除标准
- •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
- •usage of painkiller before surgery
- •addiction to alcohol or recreational drugs
研究组 & 干预措施
ESP block
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.
干预措施: Erector spinae plane block (Procedure)
Controlled
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
干预措施: General anesthesia (Procedure)
Controlled
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
干预措施: Patient-controlled analgesia (Procedure)
Controlled
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
干预措施: Oxycodone (Drug)
Controlled
Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.
干预措施: paracetamol (Drug)
ESP block
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.
干预措施: General anesthesia (Procedure)
ESP block
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.
干预措施: Patient-controlled analgesia (Procedure)
ESP block
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.
干预措施: Oxycodone (Drug)
ESP block
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.
干预措施: paracetamol (Drug)
Sham block
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.
干预措施: Sham block (Procedure)
Sham block
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.
干预措施: General anesthesia (Procedure)
Sham block
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.
干预措施: Patient-controlled analgesia (Procedure)
Sham block
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.
干预措施: Oxycodone (Drug)
Sham block
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.
干预措施: paracetamol (Drug)
结局指标
主要结局
Quality of recovery 40
时间窗: Before the hospital discharge
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.
次要结局
- Patient-controlled analgesia (PCA)(24 hours from the connection of the PCA pump in the post-anesthesia care unit.)
- Visual analog scale(up to 24 hours after the surgery)
- Total oxycodone consumption(up to 24 hours after the surgery)
研究者
Michał Borys
associate professor
Medical University of Lublin