Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Opioid consumption in the first 24 hours after surgery
研究概览
简要总结
This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.
详细描述
It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.
This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched.
In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.
Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
排除标准
- •Age <18 or> 65, ASA 3-4 patients
- •Obesity (> 100 kg, BMI> 35 kg / m2)
- •Patients undergoing bilateral mastectomy
- •Pregnancy
- •Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- •Serious renal, cardiac, hepatic disease
- •Hypersensitivity to local anesthetics or a history of allergy
- •Patients with a history of opioid use longer than four weeks
- •Patients with psychiatric disorders or communication difficulties
- •Patients with chest deformity
- •Patients with previous breast surgery except diagnostic biopsies
- •Patients who do not want to participate
结局指标
主要结局
Opioid consumption in the first 24 hours after surgery
时间窗: 1 day
Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.
次要结局
- Remifentanil consumption during the surgery(During the surgery)
- Post-operative acute pain(1 day)
- The incidences of post-operative nausea and vomiting (PONV)(1 day)
- The number of patient required rescue analgesia(1 day)
- Post-operative chronic pain(3. month after surgery)
研究者
Caner Genç
Medical Doctor
Ondokuz Mayıs University