Comparative evaluation of Ultrasound guided Serratus anterior plane block versus Erector spinae plane block for postoperative analgesia in modified radical mastectomy-A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate and compare the time to first dose of rescue analgesic in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block.
研究概览
简要总结
Breast cancer is the most common cancer found in women worldwide.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing breast cancer surgery.Various techniques like the wound infiltration, intravenous opioids, thoracic epidural and thoracic paravertebral have been used for postoperative pain management in these patients.Recently, fascial plane blocks are being increasingly employed for intraoperative and postoperative pain management in these patients.These fascial plane blocks include Modified Pectoralis nerve block, Serratus anterior plane block and Erector spinae plane block.Among all regional anaesthetic techniques, which is the most efficacious, safe, technically simple and less time consuming is questionable.No randomized clinical trial has been done to compare the analgesic efficacy of ESPB and SAP block.Hence we planned a prospective randomized clinical trial to compare the analgesic efficacy of SAP block and ESPB in 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 Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients with carcinoma breast
- •Age group -18-70 years
- •ASA Physical status 1,2,3 scheduled to undergo modified radical mastectomy.
排除标准
- •1.Patients Refusal 2.Patients with infection at the site of SAP or ESPB block 3.Patients with severe chest wall deformity 4.Patients with history suggestive of coagulopathy or receiving any anticoagulants 5.Presence of complications like mental illness, severe heart disease (NYHA classification ≥3) 6.Any renal or hepatic disorder before surgery 7.Allergic to any drug being used during the study.
结局指标
主要结局
To evaluate and compare the time to first dose of rescue analgesic in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block.
时间窗: To evaluate and compare the time to first dose of rescue analgesic at the time when numerical rating score more than 4 in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block.
次要结局
- a.To evaluate and compare the total dose of rescue analgesic needed intraoperatively.(b. To evaluate and compare the total dose of rescue analgesics required postoperatively.)