“A Study of safety and efficacy of IITV guided erector spinae plane(ESP) Block as novel multimodal analgesia technique for postoperative analgesia in Modified Radical Mastectomy(MRM).â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total requirement of rescue analgesia in first 24 Hrs.
研究概览
简要总结
Modified Radical Mastectomy(MRM)is one of the commonly performed surgery. It is associated with moderate-to-severepostoperative pain. Regional block for pain management has many advantages insuch patients including provision of adequate analgesia, reduced need foropioids, decreased postoperative nausea & vomiting, postoperative pulmonarycomplications, enhanced recovery, and early ambulation. The Ultrasound(US)/IITV guided Erector Spinae Plane Block (ESPB) was initially described byForero for providing thoracic analgesia at the T4 transverse process (TP). ESPBgained wide attention as it is a faster procedure that carries a lower risk ofhypotension, easy to perform, and requires less training.
Here, we compared the efficacy of unilateralErector Spinae Plane Block(ESP Block) with Bupivacaine (0.25%) with systemicpost-operative analgesics alone for duration, quality of post-operativeanalgesia for patients undergoing modified radical mastectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anaesthesiologists(ASA) Grade – I, II and III patients b.
- •Patients undergoing Modified Radical Mastectomy(MRM) surgery.
排除标准
- •American Society of Anaesthesiologists(ASA) Grade IV and V patients b.
- •Patients of Age Group >65 years c.
- •Infection at the block site d.
- •Bleeding disorder or Patient is on Anti-Coagulation Therapy e.
- •Allergic reaction to any anaesthetic drug f.
- •Patients on tranquilizers, hypnotics, sedatives and other psychotropic drugs.
- •Severe Hepatic/Renal/Endocrine/Neurologic/Gastrointestinal or Cardiac dysfunction h.
- •Those who unable to speak or understand commands for analyzing sedation and analgesia.
- •Spine deformity j.
- •Patient’s refusal.
结局指标
主要结局
Total requirement of rescue analgesia in first 24 Hrs.
时间窗: Postoperatively every 30 mins for first 2 hours, every 60 mins for next 6 hours and at 12th hour and 24th hour.
次要结局
- a. Changes in Hemodynamic Parameters(b. Side Effects if any peri-operatively)