The Efficacy of Ultrasound-guided Pecto-Intercostal Fascial Plain Block Versus Lidocaine Infusion on Acute and Chronic Post-sternotomy Pain; A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Total dose of morphine in the first 24 h postoperatively.
研究概览
简要总结
Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .
详细描述
Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.
Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PSPS
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
- Single (Participant)
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
- 是
入选标准
- •age between 18 and 75 years.
- •patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
- •American Society of Anesthesiologists classification of physical status < IV.
排除标准
- •emergency surgery.
- •off-pump surgery.
- •redo surgery.
- •ejection fraction less than 35%.
- •refusal of the patient.
- •known hypersensitivity to LA.
- •chronic opioid use or chronic pain patient.
- •psychiatric problems or communication difficulties.
- •liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
- •renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
- •obstructive sleep apnea syndrom.
- •coexisting hematologic disorders.
- •pregnancy or breastfeeding.
研究组 & 干预措施
PIFB group
patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.
干预措施: pecto intercostal fascial block using bupivacaine 0.25% (Procedure)
LIDOCAINE group
1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.
干预措施: lidocaine infusion (Drug)
结局指标
主要结局
Total dose of morphine in the first 24 h postoperatively.
时间窗: 24 hours postoperative
total morphine consumed in the first 24 hour
次要结局
- length of intensive care stay(within one week)
- NRS numerical rating scale.(24 hours post operative)
- chronic postoperative pain in 3 months after operation according to numerical rating scale(within 3 months postoperative)
- Time to rescue analgesic(within 24 hour postoperative)
- time to extubation(within 24 hour post operative)
研究者
Mariana Soliman
Lecturer of anaesthesia, surgical intensive care and pain managment
Beni-Suef University