The Effects of Serratus Plane Block Performed Under Direct Vision on Post-operative Pain in Breast Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 主要终点
- To assess the serratus plane block's effectiveness in the management of post operative pain following mastectomy when compared to wound infiltration alone
研究概览
简要总结
The aim of the study is to determine the effectiveness of serratus place block in the control of post-operative pain following mastectomy. The investigators will compare one group of patients receiving serratus plane block and wound infiltration to a control group receiving a saline injection into serratus anterior and wound infiltration with local anaesthetic only. The investigators will compare our results to the National Mastectomy and Breast Reconstruction Audit's reported rate of 6.2% of patients reporting severe pain following mastectomy to see if there is an improvement of the national standard. In the serratus block group, the investigators expect a 50% decrease in the number of patients who report severe pain day one post operatively.
详细描述
Patients who undergo mastectomy +/- sentinel node biopsy +/- axillary clearance +/- implant reconstruction will be eligible for the study. Patients will be consented by Mr Davies preoperatively in the breast clinic at Kingston Hospital to be randomly allocated to one of two groups.
The study will be double blinded and patients will be randomly allocated in to one of two groups as detailed below:
Group 1 - Control Group The first group will act as the control group and will receive wound infiltration with the full amount of local anaesthetic (40mls) around the drain sites and axillary wound, if present, as is standard practice. They will also receive a 20ml injection of 0.9% saline deep to serratus anterior under direct observation. Infiltration of saline will be delivered into 2-3 muscular slips (typically ribs 4-6) in the anterior axillary line. The local anaesthetic will be prepared according to body weight and a dose of 0.375% of chirocaine will be used with the addition of 1:200000 adrenaline and 1 microgram/kg of clonidine.
Group 2 - Serratus Plane Block Group
The second group will receive a serratus plane block and wound infiltration as described below:
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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
- •Patients who undergo mastectomy +/- sentinel node biopsy +/- axillary clearance +/- implant reconstruction will be eligible for the study
排除标准
- •Patients under the age of 18.
结局指标
主要结局
To assess the serratus plane block's effectiveness in the management of post operative pain following mastectomy when compared to wound infiltration alone
时间窗: 18 months
次要结局
- To determine the proportion of patients receiving a serratus plane block during mastectomy who go on to develop chronic pain syndromes compared to patients receiving wound infiltration alone(18 months)
研究者
Marcus Hards
Doctor
Kingston Hospital NHS Trust