Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Tumescent Anesthesia in Reduction Mammoplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Use of analgesic consumptions
研究概览
简要总结
In breast reduction surgery, pain control is usually performed with tumescent anesthesia, thoracic epidural anesthesia, intercostal nerve blocks and paravertebral block applications. Tumescent anesthesia is also preferred by plastic surgeons because of the varying risk of thoracic epidural anesthesia and paravertebral block applications.
After the Erector spinae block was first described by Forero in 2016, it was reported to have been applied in many cases, including breast surgery.
It is considered to be a safer block because of the presence of paravertebral block-like activity and the location where the needle is guided away from the pleura. The investigators aimed to compare postoperative analgesia consumption, pain scores and patient satisfaction of erector spine block with tumescent anesthesia in patients who underwent reduction mammoplasty operation under general anesthesia in this double-blind prospective randomized study.
详细描述
Patients aged 18-65 years undergoing bilateral reduction mammoplasty. Patients were randomly divided into two groups with closed envelope to perform tumescent anesthesia and erector spinae block.
All patients were premedicated with oral midazolam 0.5 mg/ kg preoperatively. All patients received standard general anesthesia protocol as induction with 2-3 mg/kg iv propofol and 1-1.5 mcg/kg fentanyl and 0.6 mg/kg iv rocuronium. Endotracheal intubations were performed 7.0 or 7.5 endotracheal tubes with the patient in a supine position. Anesthesia maintenance was with sevoflurane 0.5/kg/mg remifentanil infusion and in a 50% O2 -50% air mixture. Standard monitoring of the patients included of heart rate, invasive systolic, diastolic and mean blood pressure and peripheral oxygen saturation and the operating times were recorded.
At approximately 30 minutes before the end of surgery, 8mg dexketoprofen IV was administered to all patients. At the end of the operation, all the patients were performed with iv PCA(Patient Controlled Analgesia).
Demographic data such as age, weight, and height of the patients were recorded. After patients informed about pain score NRS (Numeric Pain Rating Scale) and patient satisfaction score ( one to ten) recorded by the nurse of PACU and ward.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The American Society of Anesthesiologists physical status classification I-III undergoing reduction mammoplasty
排除标准
- •History of allergic reactions to local anesthetics Rash or infection at the injection site Anatomical abnormality Bleeding diatheses Coagulopathy liver diseases
研究组 & 干预措施
Erector Spinae Plane Block
Before the general anesthesia Erector Spinae Plane Block was performed.
干预措施: Erector Spinae Plane Block (Procedure)
Tumescent Anesthesia
After the general anesthesia was given, 1 mL of 0.1% adrenaline (1/1000) and as 20 mL of 0.5% bupivacaine solution of tumescent in a total of 1000 mL Ringer's lactate applied by the surgeon applied equally to both breasts
干预措施: Tumescent Anesthesia (Procedure)
结局指标
主要结局
Use of analgesic consumptions
时间窗: 24 hour
Total tramadol consumptions with patient controlled device
次要结局
- Numeric Pain Rating Scale(30 minute, 1,2,4,6,12,24 hour)
研究者
Gözen Öksüz
Assistant Professor
Kahramanmaras Sutcu Imam University