临床试验/NCT03781440

NCT03781440进行中（未招募）不适用

Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy

Stanford University2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2020年1月1日最近更新: 2023年9月22日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Stanford University
入组人数: 60
试验地点: 2
主要终点: Opioid Consumption

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the duration of postoperative mechanical ventilation, need for intravenous opioid medications, length of stay in the intensive care unit (ICU), and improving pain scores.

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, Care Provider)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Give consent to participate in study
•planned sternotomy
•specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
•Primary or first redo sternotomy

排除标准

•Participants who cannot give consent
•Patients who are clinically unstable or require urgent/emergent intervention
•more than1 prior sternotomy
•planned aortic arch procedures
•preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)
•Severe ventricular dysfunction (left or right ventricle)
•Symptomatic heart failure (systolic or diastolic)

结局指标

主要结局

Opioid Consumption

时间窗: Duration of postoperative recovery (typically 1-2 weeks)

IV and PO opioid requirements converted to morphine equivalent

次要结局

Length of stay in ICU(Duration of postoperative recovery (typically 1-2 weeks))
Inflammatory biomarker analysis(First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure)
Delirium and agitation post-operatively(Duration of ICU stay (typically 2-5 days))
Quality of recovery at 72 hours(post-operative day 3)
Determine post-operative pain scores(Duration of postoperative recovery (typically 1-2 weeks))
Median time to extubation in patients with ESPB(Duration of postoperative recovery (typically 1-2 weeks))
Length of stay in hospital(Duration of postoperative recovery (typically 1-2 weeks))

研究者

发起方

Stanford University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Chi-Ho Ban Tsui

Professor

Stanford University

研究点 (2)

Loading locations...

相似试验

已完成

不适用

Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) StudyCongenital Heart DefectAnesthesia, LocalOpioid UseCongenital Heart Disease

NCT03611374Stanford University38

已完成

4 期

Effectiveness of Combined Erector Spinae and Pecto-intercostal Fascial Plane Blocks Versus Thoracic Paravertebral Block in Perioperative Pain in Modified Radical MastectomyModified Radical Mastectomy

NCT04778267Kasr El Aini Hospital30

撤回

早期 1 期

Evaluation of Erector Spina Plane Block(ESPB)'s Effectiveness on Patients With Lumbar RadiculopathyRadiculopathyRadiculopathy LumbarPain, Back

NCT05261581Bezmialem Vakif University46

已完成

不适用

Comparing Erector Spinae Plane (ESP) and Transversus Abdominis Plane (TAP) Block in Inguinal HerniaPostoperative PainAnesthesia, LocalAnesthesia ComplicationInguinal Hernia

NCT04750512Ghielmini Enea50

已完成

不适用

Erector Spinae Plane Block Versus Intercostal for VATSLung DiseasesLung Cancer

NCT03902782McGill University Health Centre/Research Institute of the McGill University Health Centre100