Pectoral Nerves Block to Relieve Post-sternotomy Pain After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Score on Critical-Care Pain Assessment Tool (CPOT)
研究概览
简要总结
The primary objective of this study is to determine if the addition of PECS2 block provides superior post-operative analgesia for cardiac surgery patients after midline sternotomy compared to only standard-of-care post-operative pain medication.
详细描述
The current study is a prospective, double-blind study investigating the use of pectoral nerves (PECS) block 2 to alleviate post-operative pain in cardiac surgery patients. The investigators anticipate enrolling a total of 220 participants in one of two groups, an interventional PECS block group and a control group not receiving the block. The intervention will occur in the operating room after the completion of the cardiac procedure and prior to the transfer of the participants to the cardiothoracic intensive care unit (CTICU). Both groups will receive the standard-of-care (SOC) pain regimen; the intervention with receive the PECS block in addition to SOC pain regimen. The procedure takes approximately five to ten minutes and will be conducted by the attending cardiac anesthesiologist. Pain will then be monitored hourly in the post-operative period in the CTICU. Additional measures will be investigated that are regularly logged in the electronic medical record.
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, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtaining one or more of the following elective surgical procedures at NYU Winthrop Hospital with midline sternotomy:
- •Coronary artery bypass graft (any number of vessels)
- •Aortic Valve Replacement (AVR)
- •Aortic Valve Repair
- •Mitral Valve Replacement (MVR)
- •Mitral Valve Repair
- •Tricuspid Valve Replacement
- •Tricuspid Valve Repair
- •Pulmonic Valve replacement
- •Pulmonic Valve Repair
- •Congenital Heart Defect Repair
- •Ascending Thoracic Aortic Aneurism Repair
- •Patient Age > 18 years.
- •Willingness and ability to participate in the study procedures
- •Sufficiently hemodynamically stable to give consent
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Hemodynamic instability
- •Preexisting infection at site of block
- •Allergy to block agents
- •Severe psychiatric illness
- •Intubated emergently prior to reception by the perioperative team
- •Patient is preoperatively on extracorporeal membrane oxygenation (ECMO) treatment.
- •Pregnant patient
- •Recent surgery
研究组 & 干预措施
Pectoral nerves block type 2 (PECS2)
The intervention is the PECS2 block, a previously developed modality for preventing pain in the anterior chest. The medication used in the block is Ropivicaine 0.5%, Lidocaine 1% + 1:100,000 epinephrine, and 40 μg dexmedetomidine. Patients will receive a standard post-operative pain regimen per institutional protocol.
干预措施: PECS2 block (Procedure)
Pectoral nerves block type 2 (PECS2)
The intervention is the PECS2 block, a previously developed modality for preventing pain in the anterior chest. The medication used in the block is Ropivicaine 0.5%, Lidocaine 1% + 1:100,000 epinephrine, and 40 μg dexmedetomidine. Patients will receive a standard post-operative pain regimen per institutional protocol.
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
Pectoral nerves block type 2 (PECS2)
The intervention is the PECS2 block, a previously developed modality for preventing pain in the anterior chest. The medication used in the block is Ropivicaine 0.5%, Lidocaine 1% + 1:100,000 epinephrine, and 40 μg dexmedetomidine. Patients will receive a standard post-operative pain regimen per institutional protocol.
干预措施: Lidocaine Epinephrine (Drug)
Pectoral nerves block type 2 (PECS2)
The intervention is the PECS2 block, a previously developed modality for preventing pain in the anterior chest. The medication used in the block is Ropivicaine 0.5%, Lidocaine 1% + 1:100,000 epinephrine, and 40 μg dexmedetomidine. Patients will receive a standard post-operative pain regimen per institutional protocol.
干预措施: Dexmedetomidine 0.004 MG/ML (Drug)
结局指标
主要结局
Score on Critical-Care Pain Assessment Tool (CPOT)
时间窗: 24 hours
Measured at least hourly prior to extubation. This is an 8-item pain inventory seen as one of the top modalities for measuring pain in critical care patients. Minimum score of 0 and a maximum score of 8 (higher score = higher pain level).
Score on Visual Analog Scale (VAS)
时间窗: 24 hours
Measured at least hourly after extubation. 10 point pain analog scale (0-10, where 0 is no pain and 10 is highest pain level)
次要结局
- Duration of hospital stay(5-7 days post-operative)
- Total post-operative opiate dose(5-7 days post-operative)
- Score on Visual Analog Scale (VAS) at 24-48h(24-48 hours)
- Ventilatory duration post-operatively(0-6 hours)
- Duration of surgery(4-6 hours)
- Time to first opiate dose for breakthrough pain(24-48 hours)
- Duration of operating room time(5-7 hours)
- Total intraoperative fentanyl dose(Intraoperative duration)
- Duration of ICU stay(24-48 hours)
- Time to first analgesic post-operatively(24-48 hours)
- Number of episodes of post-operative breakthrough pain(24-48 hours)
- Score on Critical-Care Pain Assessment Tool (CPOT) at 24-48h(24-48 hours)
- Number of adverse events related to safety of the nerve block(5-7 days post-operative)