Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Change in postoperative pain score
研究概览
简要总结
The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.
详细描述
Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block).
- group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance
- Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: from 18 to 75 years.
- •Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) via median sternotomy and under CPB (cardiopulmonary bypass)
- •Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation).
排除标准
- •• Previous, urgent, or emergent cardiac surgery.
- •Patients undergoing coronary artery bypass grafting (CABG)
- •local infection of the skin at the site of needle puncture,
- •Allergy to bupivacaine,
- •Coagulation disorders,
- •Clinically significant liver or kidney disease,
- •Heart failure or severe pulmonary hypertension.
- •severe renal, pulmonary, liver, or endocrine systemic disease,
结局指标
主要结局
Change in postoperative pain score
时间窗: 24 hours
Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. A score of 0 is "no pain and a score of 10 is "worst imaginable pain"
次要结局
- Amount of rescue analgesia(24 hours)
研究者
Mohamed Ahmed Ali Ahmed
Doctor
Assiut University