The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the cure rate of AGI
研究概览
简要总结
In this single-center, randomized, parallel control clinical trial, patients will be randomly assigned to two groups. The treatment group receives ultrasound-guided erector spinae plane block with routine treatment of Acute Gastrointestinal Injury (AGI) for 7 days or until transferred to the general ward, while the control group only receives routine treatment of AGI. The primary outcome is the cure and remission rate of AGI.
详细描述
Detailed Description:
Study title: The treatment of Acute Gastrointestinal Injury via ultrasound-guided erector spinae plane block - a prospective, single-center, randomized, controlled trial
Principal Investigator: Professor Wang Hua, Department of Critical Care Unit, Zhujiang Hospital of Southern Medical University
Study subjects: Patients age from 18 to 80 with AGI Ⅱ or greater
Study phase: Investigator Initiated Trial(IIT)
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
- None
盲法说明
This study adopted a randomized, open, blank control design, and did not blind researchers, patients or clinicians.
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
- •AGI are diagnosed according to the diagnostic criteria proposed by European Society Intensive Care Medicine (ESICM) in 2012 and the AGI grade great than or equal to II.
- •Age 18-80 years.
- •Expected length of stay longer than 3 days.
排除标准
- •Mean arterial pressure is still less than 65 millimeter of Mercury (mmHg) treated with rehydration and vasoactive agents, or with the dosage of norepinephrine more than 0.5ug/kg/min.
- •Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.
- •Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.
- •Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.
- •Neuromuscular disorders.
- •Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.
- •Brain dead.
- •Malignant tumor, or end-stage cachexia.
- •With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.
- •Allergy to local anesthetics.
- •Significant abnormalities in blood coagulation parameters.
- •Without written informed consent.
研究组 & 干预措施
Experimental Group
On the basis of the clinical routine treatment of AGI in severe patients, the Experimental Group will receives ultrasound-guided erector spinae plane block with routine treatment of AGI for 7 days or until transferring to the general ward.
干预措施: Ropivacaine injection (Drug)
结局指标
主要结局
the cure rate of AGI
时间窗: on the day7
the cure rate of AGI on the day7
the remission rate of AGI
时间窗: on the day7
the remission rate of AGI on the day7
次要结局
- The 28-day mortality(From enrolled to 28 days or the termination date)
- Width of the colons(on the day 0,1,3 and 7)
- White Blood Cell(WBC)(on the day 0,1,3 and 7)
- Interleukin-6(IL-6)(on the day 0,1,3 and 7)
- Neutral Granular Cell(NEUT)(on the day 0,1,3 and 7)
- Hypersensitive C Reactive Protein(HSCRP)(on the day 0,1,3 and 7)
- The lactic acid(Lac)(on the day 0,1,3 and 7)
- Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score(on the day 0,1,3 and 7)
- abdominal perfusion pressure(AAP)(on the day 0,1,3 and 7)
- Gastrointestinal dysfunction and duration(GIF)(on the day 0,1,3 and 7)
- The length of stay in ICU(on the day 28 or through study completion)
- Cross-sectional area of pyloric antrum(AS)(on the day 0,1,3 and 7)
- Lymphocyte (LYM)(on the day 0,1,3 and 7)
- Acute Physiology and Chronic Health Evaluation(APACHE II)(on the day 0,1,3 and 7)
- the intraperitoneal pressure(IAP)(on the day 0,1,3 and 7)
- total gastric residual volume(GRVs)(on the day 0,1,3 and 7)
- feeding dose(on the day 0,1,3 and 7)
- Procalcitonin (PCT)(on the day 0,1,3 and 7)
- The total days of hospitalization(on the day 28 or through study completion)