Prospective Comparison of Single-Injection Serratus Anterior Plane Block With Ropivacaine Versus Local Infiltration of Anaesthetic After Breast Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- The use of opioids in the postoperative period
研究概览
简要总结
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
详细描述
To evaluate whether a serratus anterior plane block (SAPB) is more effective than a local infiltration anesthesia (LIA) with an equal dose and same anesthetic performed by the surgeon, as an adjuvant to treat postoperative pain after unilateral mastectomy.
Primary endpoint: the use of opioid's in the postoperative period. Secondary endpoint: Numerical Pain Rating Scale (NPRS) score recorded at the 2nd, 8th, 16th, 24th hour after surgery. 0 means no pain and 10 is the worst pain imaginable. In addition at the same time, we will look to the degree of arm mobilization where there will be 3 possible groups: 1. restricted, 2. fair mobilization and 3. free mobilization.
There are 2 treatment arms: 1st arm is the standard therapy, namely the local infiltration anesthesia. 2nd arm is the experimental arm, namely the SAPB. Patients are randomised into each arm after screening.
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
- Double (Participant, Outcomes Assessor)
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
- •Age 18-80 years.
- •Provision of signed informed consent prior to any study-specific procedure.
- •Patients who come to preoperative anesthesia consultation for their scheduled unilat-eral mastectomy.
排除标准
- •Age >80 years
- •History of chronic pain or drug treatment abuse
- •Depression, psychiatric morbidity or mal-adaptive coping behavior
- •Neuropathy
- •Severe anxiety or other mental ailment, taking drugs affecting their capacity to assess pain
- •Chronic or acute skin infection of the lateral thorax
- •Hypersensitivity to ropivacaine
- •Severe hepatic or renal disease
- •Refuse to participate to the study
- •Pregnancy
结局指标
主要结局
The use of opioids in the postoperative period
时间窗: 24 hours
Patients receive a patient controlled intravenous anesthesia pump with morphine. We will be able to analyze the total amount of opioid requested by the patient.
次要结局
- Numerical Pain Rating Scale(24 hours)
- Degree of arm mobilization(24 hours)