Prospective Unicentre Non-randomised Study: Comparison of Postoperative Pain After Breast Cancer-typical Surgery Under Tumescent Local Anaesthesia Versus General Anaesthesia - TLA 001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
The present study aims to investigate the impact of Tumescent Local Anesthesia (TLA) on pain perception following surgeries typical for breast cancer. Previous research has already confirmed the feasibility of conducting operations in TLA for benign breast conditions. In contrast to general anesthesia, Tumescent Local Anesthesia involves local anesthesia of the surgical site, allowing patients to remain awake during the procedure and eliminating the risks associated with general anesthesia. Additionally, if needed, sedatives or further anesthesia can be administered through the vein. Building upon the successful applications of TLA in benign breast surgeries, this follow-up study at the Department of Women's Health focuses on enhancing surgical techniques, pain management, and postoperative care for breast cancer-related procedures. Simultaneously, our goal is to gather scientific data regarding the application of this technique. This research contributes to the continuous advancement of medical practices in the field of breast surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Written informed consent
- •Histologically confirmed breast carcinoma or pure ductal carcinoma in situ
- •Planned operation:
- •Segmental resection/ breast-conserving surgery
- •Segmental resection/ breast-conserving surgery with SNB
- •Ablatio with SNB/ axilla exploration
排除标准
- •Expected lack of patient compliance or inability of the patient to understand the purpose of the study
- •Lack of patient consent
- •Pregnancy
- •Complete axillary dissection
- •Tumour-adapted reduction surgery, implant reconstructions
- •Surgeries where technical difficulties are expected under any anaesthesia (e.g. ASA IV, BMI > 40)
- •Bilateral breast operations
- •Exclusion Criteria for surgery in TLA:
- •Injection phobia
- •Psychoses/ previous psychological illnesses
- •Advanced dementia
- •Language barrier
研究组 & 干预措施
Control Group
Surgery carried out according to clinical routine under general anaesthesia.
干预措施: General Anaesthesia (Procedure)
Local Anaesthesia Group
Surgery carried out under local tumescent anaesthesia. Procedure
干预措施: Local tumescent anaesthesia (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: 5 weeks
The primary endpoint is the recording of postoperative pain. Pain will be measured on 1.-3. postoperative day using the Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Additionally, the postoperative pain will be assessed using the VAS at the post-operative follow-up consultation, which usually takes place 2-5 weeks after surgery.
次要结局
- HRQoL/ Quality of life(5 weeks)
- Duration of surgery(1 until 5 hours)
- Follow-up surgery for R1 situation(5 hours)
- Satisfaction of the surgeon with the course of the operation(5 hours)
- Postoperative pain medication requirements(5 weeks)
- Complications(5 weeks)
- Length of hospital stay(1 day until 2 weeks)
- Drainage delivery rate(Surgery until discharge (1 day until 2 weeks ))
- Costs(5 weeks)
- Preoperative fear of surgery and anaesthesia(30 Minutes)