Comparison of ultrasound-guided erector spinae plane block with serratus anterior muscle block in patients undergoing modified radical mastectomy- A randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the reduction in pain intensity in post-operative period by using linear visual analogue scale (VAS) score in patients receiving either ESP block or SAM block following MRM.
研究概览
简要总结
Breast cancer is the most common cancer in females and is the leading cause of cancer related deaths.The standard treatment options for early and localized breast cancer includes surgical modalities with modified radical mastectomy (MRM) being the most commonly employed surgical procedure undertaken for carcinoma breast. Pain following MRM is the major concern in the post-operative period as it can lead to poor surgical outcome and also has propensity to develop into chronic pain syndrome affecting 25-60% of the patients.Various modalities such as intravenous analgesics( opioids and non-opioids) and regional anaesthetic techniques such as thoracic epidurals,interscalene blocks,paravertebral blocks,cervical epidural blocks etc have been employed to control post-operative pain following MRM.Each modality has its pros and cons.
Recently introduced ultrasound guided regional anaesthetic techniques have gained attention due to precise visualization of the anatomy of area concerned along with less complications.Erector spinae plane(ESP) block is the recently introduced block,first described by Forero for thoracic neuropathic pain.In ESP block, local anesthetic (LA) is injected deep to erector spinae muscle and superficial to transverse process ( usually at the level of T5) and provides pain relief by blocking ventral and dorsal rami along with lateral cutaneous branches of the intercostal nerves.Another block ,Serratus anterior muscle (SAM) block described by Blanco has also been advocated to provide pain relief by virtue of blocking lateral cutaneous branches of thoracic intercostal nerves. In SAM block, LA is injected in between lattisimus dorsi and serratus anterior muscle.
There are very few studies in the literature where ESP block has been used to provide post-operative analgesia in MRM parients . Hence the present study has been designed to compare these two regional anesthetic techniques and their effectiveness in controlling post-operative pain in patients scheduled to undergo MRM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Females suffering from carcinoma breast.
- •2.American Society of Anaesthesiologists status I-II 3.Age ranging from 18-80 years.
排除标准
- •1.Patient refusal.
- •2.History of relevant drug allergy.
- •3.History of psychiatric illness and substance abuse.
- •4.Patient suffering from severe cardiovascular, respiratory,liver, metabolic or neurological disease.
- •5.Chronic treatment with analgesics.
- •6.Pregnant patient.
- •7.Coagulopathy.
- •8.Infection at planned injection site.
- •9.Psychological inability of the patient to understand and interpret visual analogue scale.
结局指标
主要结局
To evaluate the reduction in pain intensity in post-operative period by using linear visual analogue scale (VAS) score in patients receiving either ESP block or SAM block following MRM.
时间窗: Post-operative at 30 mins,1 hr,4 hrs,8 hrs,12 hrs and 24 hrs.
次要结局
- 1.Morphine consumption over 24 hrs(2.Total dose of antiemetics over 24 hours.)