Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sympathetic block level evaluation by hemodynamic data
研究概览
简要总结
The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.
详细描述
Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).
After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.
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
- Triple (Participant, Care Provider, 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
- •ASA(American Society of Anesthesiologist) physical classification I-III
- •Patients undergoing unilateral mastectomies due to malignancy
排除标准
- •Active infection at the intervention site
- •History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
- •Major cardiac, pulmonary, renal and neurological diseases
- •Autonomic neuropathy or use of drugs that affect autonomic function
- •Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
- •Allergic to local anesthetics;
- •Patients who are uncooperative or have psychiatric problems
- •Morbidly obese (body mass index > 35 kg/m2)
结局指标
主要结局
Sympathetic block level evaluation by hemodynamic data
时间窗: 45 minutes after block administration
Peri-operative heart rate and mean arterial pressure will be recorded
Sensorial block level evaluation
时间窗: 45 minutes after block administration
By pin-prick test
Sympathetic block level evaluation with skin temperature
时间窗: 45 minutes after block administration
Skin temperature of bilateral thorax will be measured
Sympathetic block level evaluation with skin conductivity
时间窗: 45 minutes after block administration
Skin conductivity will be measured by galvanic skin response (GSR)
Sympathetic block level evaluation with hot cold test
时间窗: 45 minutes after block administration
Hot cold test of bilateral thorax will be measured
次要结局
- Postoperative pain scores(24 hours after operation)
- intraoperative hemodynamic data(During the operation)
- Rescue analgesics consumption(24 hours after operation)
研究者
Gulay ERDOGAN KAYHAN
Professor, MD
Inonu University