The Pectoral Nerve Block (PECBLOCK) for the Treatment of Pain After Breast Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Pain score at rest in the recovery room
研究概览
简要总结
Pain after breast cancer surgery could be severe and about 1/3 of patients will develop chronic pain. The PECBLOCK is the injection of local anesthetics between the two pectoral muscles to block pectoral nerves and intercostal nerves innervating the breast. The aim of this study is to evaluate the efficacy of the PECBLOCK performed under echoguidance in minor and major breast surgery. The prevention of chronic pain following surgery will also be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-85 yrs old
- •patients ASA status I-IV
排除标准
- •refusal of the PECBLOCK
- •allergy to a drug used in the protocol (local anesthetic)
- •patients with chronic pain before the surgery
研究组 & 干预措施
PECBLOCK performed with bupivacaine
Active drug given through PECBLOCK in these patients.
干预措施: PECBLOCK under echoguidance (Procedure)
PECBLOCK performed with NaCl 0.9%
Placebo drug given through PECBLOCK in these patients
干预措施: PECBLOCK under echoguidance (Procedure)
结局指标
主要结局
Pain score at rest in the recovery room
时间窗: 30 min after entering the recovery room or just before morphine administration if needed
Using a 0-10 verbal numerical scale where 0 is no pain and 10 the worst pain imaginable
次要结局
- Total morphine consumption in the recovery room(in the recovery room before discharge (after 1 h on average)))