Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- chronic postoperative pain intensity
研究概览
简要总结
Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem.
The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having an age greater than or equal to 18 years and less than 70 years
- •Having given written consent for participation in the study and the use of personal and medical data
- •Having a physical status of class I, II or III of the American Society of Anesthesiologists
排除标准
- •Patients who expressed their refusal to participate in the study
- •Patients unable to express their non-objection to participation in the study
- •American Society of Anesthesiologists class > III patients
- •Known allergy to local anesthetics
- •A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
- •Morbid obesity (body mass index greater than 40 kg/m²)
- •Chronic use of opioids
- •Inability to use the patient controlled analgesia device
- •The existence of preoperative pain
- •History of neuropathy or neurological pathology
- •The existence of catastrophism or anxiety diagnosed preoperatively
研究组 & 干预措施
Placebo
干预措施: Serratus Anterior Plane Block with saline solution (Procedure)
Serratus anterior plane block
干预措施: Serratus Anterior Plane Block with local anesthetic (Procedure)
结局指标
主要结局
chronic postoperative pain intensity
时间窗: 3 months after surgery
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of Serratus Anterior Plane Block in preventing chronic pain
Chronic postoperative pain at 3 months
时间窗: 3 months after surgery
A question will be asked to patients : "Throughout our lives, most have had pain (like headaches, sprains and toothaches). Have you had pain other than these types of pain on a daily basis since your surgery? " The answer "yes" or "no" will determine the outcome
次要结局
- Morphine consumption(0-24 hours after operation)
- Chronic Pain intensity and quality(3 months after surgery)
- Neuropathic pain screening(3 months after surgery)