Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- postoperative chronic pain assessed using the DN4 questionnaire
研究概览
简要总结
This study compare the "Serratus block plane" (SPB) and the local infiltration of the tissue in the prevention of acute and chronic pain after breast cancer surgery.
详细描述
Chronic pain after breast surgery may be severe, often requiring the use of morphine. The incidence of chronic pain varies from 27 to 50% depending on definitions.
The infiltration of tissues by a local anesthetic is a simple, fast and low risk technique but of limited effectiveness.
Serratus the flat block, performed under ultrasound guidance, is minimally invasive and easy to perform. It allows anesthesia and analgesia to an extended part of the anterolateral chest wall and the axilla. This regional anesthesia technique provides good analgesia during and after breast surgery, but remains to be evaluated; beyond perioperative analgesia, the benefit-risk, post operative rehabilitation, and the impact on ambulatory and on chronic pain are fundamental objectives.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women scheduled for elective breast neoplasm surgery
- •Of ASA classification 1, 2 or 3
- •Patients who provide written informed consent
排除标准
- •Minor patients
- •Patients refusing to sign the consent
- •Patients included in another protocol within 3 months
- •Pregnant or lactating patients
- •Patients with history of allergy to local anesthetics (Ropivacaine)
- •Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)
- •Patients with history of prior breast surgery (excluding diagnostic biopsy)
- •Patients with history of chronic pain
- •Patients with a history of psychiatric disorder
结局指标
主要结局
postoperative chronic pain assessed using the DN4 questionnaire
时间窗: 3 months postoperative
DN4 questionnaire
次要结局
- postoperative acute pain(day 1, day 2, day 3 postoperative)
- morphine consumption(day 1, day 2, day 3 postoperative)
研究者
Céline Boudart
MD
Erasme University Hospital