Analgesic Efficacy of Erector Spinae Plane Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Patients Undergoing Cardiac Surgery: A Randomized Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The total opioid consumption in first 24 hours after surgery.
研究概览
简要总结
The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
详细描述
The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block & thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 21 to 65 years.
- •Both sexes.
- •Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.
排除标准
- •History of chronic pain or Long-term or recent use of opioids.
- •History of allergy to local anesthetic drugs.
- •Ejection fraction of left ventricle less than 30%.
- •History of psychiatric diseases or any neurological disorders.
- •Pre-existing major organ dysfunction as hepatic or renal failure.
研究组 & 干预措施
Erector spinae plane block group
At the level of fourth thoracic vertebra, the ultrasound transducer (5-14 Mhz) Philips CX50 will be placed in the sagittal plane and moved 3 cm to visualize the transverse process of T4 or T5 with erector spinae muscle overlying it, the needle will be inserted in plane into the facial plane deep to the erector spinae muscle with the tip contacting the transverse process of T4 or T5. After confirmation by 5 ml saline, 20 ml bupivacaine 0.25% will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.
干预措施: Erector spinae plane block (Drug)
Combined Pecto-intercostal and recto-intercostal fascial plane block group
A high-frequency ultrasound transducer will be placed 2 cm lateral to sternal edge at the level of 4th rib. A needle will be inserted in-plane under ultrasound guidance through the pectoralis major muscle, and the drug will be deposited in the pecto-intercostal fascial plane located between the pectoralis major muscle and the fourth rib (or intercostal muscle) after confirmation by 5 ml saline. 10-15 mL of 0.25% bupivacaine will be injected for each side. Then the transducer will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area.The needle will be inserted between RAM and the costal cartilages with an in-plane technique in a caudo-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 10-15 mL of 0.25% bupivacaine will be injected for each side.
干预措施: Combined Pecto-intercostal and recto-intercostal fascial plane block (Drug)
结局指标
主要结局
The total opioid consumption in first 24 hours after surgery.
时间窗: 24 hours after surgery.
opioid analgesia will be given if the pain scores ≥ 4.
次要结局
- Intraoperative fentanyl dose(Until the end of surgical procedure.)
- Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.(48 hours after surgery.)
- Extubation time(24 hours after surgery.)
- Side effects(24 hours after surgery.)
- Incidence of chronic pain at 3, and 6 months after surgery.(6 months after surgery.)
- Opioid consumption in the second day after surgery.(48 hours after surgery.)
研究者
Osama Rehab
lecturer of anesthesiology, surgical intensive care and pain medicine
Tanta University