Erector Spina Plane Block Versus Deep Serratus Anterior Plane Block for Post Mastectomy Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Post-operative pain intensity
研究概览
简要总结
Breast cancer surgery like Mastectomy and modified radical mastectomy are associated with significant postoperative pain, and management depends largely on patient controlled analgesia with intravenous Morphine or other opioids equivalents. Respiratory depression, Ileus, sedation, nausea and vomiting are some of the potential side effect of opioid treatment which prolonged hospital length of stay and increase the coast. Recent advance in ultrasound guided regional anesthesia has led to the development of two novel regional anesthesia techniques specific to chest wall analgesia; Erector spina plain block and Serratus anterior plain block, with its potential to reduce or eliminate the need for opioids to manage post-operative pain.
详细描述
Experimental: erector spinae plain block After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, and prepping para-spinous area with antiseptic solution. Ultrasound high frequency linear transducer is positioned in a para-sagittal plane at the level of fifth thoracic vertebra. Scanning of interested structures from superficial to deep planes, Trapezius muscle, Rhomboid major muscle, Erector spina muscle and transverse process of fifth thoracic vertebra.
Comparator: serratus anterior plane block After giving general anesthesia, patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. Under sterile aseptic technique, a linear ultrasound transducer (6-15 MHz) is placed in a sagittal oblique plane over the fourth and fifth ribs at the mid-axillary line. The following muscles are identified overlying the fourth/ fifth rib: the latissimus dorsi (superficial) and serratus anterior muscle (deep) overlying the ribs.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor is not aware of the study type
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-III patients age 18 to 75 years undergoing unilateral breast surgery
排除标准
- •Patients refusal
- •History of amide local anesthetics allergy
- •Alcohol or drug abuse
- •Chronic opioid intake
- •Language barriers
- •Patient with psychiatric disorders
- •Contraindications for regional anesthesia
- •BMI > 40 Kg/m2
- •Obstructive sleep apnea that preclude PCA opioids
结局指标
主要结局
Post-operative pain intensity
时间窗: pain at 24 hours post operative
pain intensity is measured by ( 11 point numerical scale from 0 to 10), where 0 is considered no pain, 10 is the worst pain
Cumulative Opioid consumption in the first 24 hours.
时间窗: 24 hours post-operative
Post- operative morphine consumption measured from patient controlled analgesia pump (PCA machine)
次要结局
- Time to patient mobilization(First 24 hours post operative( 0 time is considered time to admission to post anesthesia care unit))
研究者
Ahmed Khaled Thallaj
Associate professor
King Saud University