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,
研究组 & 干预措施
US-guided post-incisional PIFB
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 the sternum after skin closure under ultrasound guidance
干预措施: US-guided Parasternal block (Procedure)
Surgeon-delivered post-incisional 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.
干预措施: Surgeon-delivered parasternal block (Procedure)
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