Assessment of a Multimodal Analgesia for Enhanced Recovery After Cardiac Surgery. A Prospective, Randomized, Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Total amount analgesic requirement
研究概览
简要总结
This work aims to assess the analgesic efficacies of transversus thoracic muscle plane block (TTPB) and transversus thoracic muscle plane block (TTPB) for open cardiac surgeries
详细描述
In patients undergoing open cardiac operation, pain management is crucial to the improved recovery. Postcardiac surgery pain is significant due to the sternotomy. The sternotomy is commonly cited as the most painful location following cardiac surgery, and postoperative pain is at its worst within the first 24 hours.
The transversus thoracic muscle plane block (TTPB) and the pectointercostal fascial block (PIFB) are new ultrasound (US)-guided regional anesthesia techniques planned to provide analgesia to the anterior thoracic wall. Both blocks primarily target the anterior cutaneous branches of the intercostal nerves (T2-T6), which are responsible for innervating the parasternal and medial anterior chest wall regions.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40 to 60 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status II-III.
- •Body mass index (BMI) < 35 kg/m
- •Underwent cardiac surgery (coronary artery bypass graft surgery with median sternotomy).
排除标准
- •Valve replacement procedures.
- •Emergency operations.
- •Redo surgeries.
- •Minimally invasive approaches.
- •The presence of psychiatric disorders.
- •Cognitive impairment preventing accurate assessment using the verbal numerical rating scale (NRS).
- •Known hypersensitivity or a history of allergy to local anesthetics.
- •Had severe major organ dysfunction.
- •Left ventricular ejection fraction below 30%.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Group PIFB
Patients will receive pecto-intercostal fascial block intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
干预措施: Pecto-intercostal fascial block (Other)
Group TTPB
Patients will receive transversus thoracic muscle plane block was performed intraoperatively (20 ml of bupivacaine 0.25% + 1 ml dexamethasone 8 mg).
干预措施: Transversus thoracic muscle plane block (Other)
Control Group
Patients will receive bilateral superficial needle puncture at a location like transversus thoracic muscle plane block without any solution injected. Only 25 saline will be injected superficially.
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Total amount analgesic requirement
时间窗: 24 hours postoperatively
In cases where rescue analgesia is required \[numerical rating scale (NRS) ≥4\], intravenous Nalbuphine 0.1 mg/kg will be given.
次要结局
- Degree of pain(24 hours postoperatively)
- The number of patients required rescue analgesia(24 hours postoperatively)
- Postoperative nausea and vomiting (PONV)(24 hours postoperatively)
- Time to extubation(24 hours postoperatively)
- Length of stay in the intensive care unit.(Average 7 days postoperatively)
- Assessment of Delirium(24 hours postoperatively)
- Level of patient satisfaction(24 hours postoperatively)
- Incidence of complications.(7 days postoperatively)
研究者
Noha Hassan Abdel-Ghany
Lecturer of Anesthesia & ICU, Faculty of Medicine, Assiut University
Assiut University