Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Measurement of Post-operative Pain
研究概览
简要总结
Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)
详细描述
There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .
Thoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .
Modified PECS's block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.
In the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 35-65 years.
- •BMI 18.5 - 25 kg/m
- •American Society of Anesthesiologists (ASA) I-II.
排除标准
- •Patient refusal.
- •Coagulopathy.
- •Mental and psychiatric disorders.
- •History of chronic pain.
- •Hypersensitivity or contraindication to any of study drugs
- •Previous chemotherapy.
结局指标
主要结局
Measurement of Post-operative Pain
时间窗: First 24-hour analgesic after Mastectomy
Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
次要结局
未报告次要终点
研究者
mohamed A Aboelsuod, MD
Assistant Professor of Anesthesia, intensive care and pain management Faculty of Medicine
Azhar University