Dexamethasone versus Dexmeditomidine as an adjunct to Ropivacaine in Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy - A Prospective Randomized Clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia in minutes( defined as time from arrival in the postoperative recovery room to administration to first rescue analgesia )
研究概览
简要总结
Patients undergoing Modified Radical Mastectomy surgeries usually have to go through severe pain postoperatively. Fascial plane blocks are emerging techniques in perioperative pain management. Serratus Anterior Plane block is one such block used in breast surgeries. Dexamethasone and Dexmedetomidine is added as an adjuvant to ropivacaine in this study because they have been reported to increase the efficacy of blockade. This study aims to compare the efficacy of combining Dexamethasone to 0.375% Ropivacaine and Dexmedetomidine to 0.375% Ropivacaine in ultrasound guided Serratus Anterior Plane Block for patients undergoing Modified Radical Mastectomy. Written informed consent will be taken and a thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria. A standard general anesthesia technique will be followed in all patients, After positioning of the patient, under strict aseptic precautions SAPB will be performed under ultrasound guided technique.Further efficacy of the block administered will be assessed with primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Breast carcinoma patients undergoing Modified Radical Mastectomy under general Anaesthesia ASA status 1 &2 Patients who consented to the study.
排除标准
- •Patients who did not consent Preexisting bleeding disorders Coagulation disorders Morbid obesity Local inflammation Study drug allergy Patient with severe chest wall deformity.
结局指标
主要结局
Time to first rescue analgesia in minutes( defined as time from arrival in the postoperative recovery room to administration to first rescue analgesia )
时间窗: assessment after arrival in the postoperative recovery room and at 1,2,6,12,24 hrs after surgery
次要结局
- 1.VAS pain score at 1,2,6,12 and 24 hours at rest (supine position ) and during activity (and on 90 degrees abduction of arm ipsilateral to the side of surgery )(2. Total perioperative analgesic consumption (intraoperative fentanyl consumption + diclofenac and tramadol consumption post operatively)
研究者
Dr Akshaya Sreekumar
All India Institute Of Medical Sciences,Bhopal