Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Sequential Organ Failure Assessment (SOFA) score
研究概览
简要总结
This study is a prospective, multicenter, parallel-group, open-label, randomized controlled clinical trial. Sepsis is defined as organ dysfunction induced by infections. And sepsis and gastrointestinal injury can be the leading cause for each other. Our previous study showed erector spinae plane block improved the organ dysfunctions in patients with AGI. The aim of the clinical trial is to investigate erector pinae plane block improves the organ dysfunction in septic patients with acute gastrointestinal injury.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic patients with acute gastrointestinal injury grade II or III;
- •Age over 18 years;
- •Expected to stay in the ICU for at least 3 days or longer;
排除标准
- •Mean arterial pressure less than 65 mmHg after fluid resuscitation, or requirement for an intravenous norepinephrine dose of greater than 0.5 µg/kg/min to maintain a normal mean arterial pressure;
- •Heart rates less than 50 beats/min, or concomitant with moderate-to-severe atrioventricular block without a pacemaker;
- •Contraindications for erector spinae plane blocks, including infection of the puncture site, spinal diseases or immobilization;
- •Primary gastrointestinal disorders requiring a surgical procedure, such as mechanical intestinal obstruction, massive gastrointestinal hemorrhage, and gastrointestinal perforation;
- •Gastrointestinal operation within one week before enrollment;
- •Neuromuscular disorders;
- •Coagulation abnormalities：activated prothrombin time or prothrombin time is prolonged with 2 folds, or platelet count less than 50×109/L;
- •End-stage malignant tumor or cachexia;
- •History of allergy to amide anesthetics;
- •Known pregnancy;
研究组 & 干预措施
Control Group
Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU. The interventions end on day 7 or cease when the patients are discharged from the ICU, dead, or withdraw their consent.
Erector Spinae Plane Block Group
- Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU.
- Ultrasound-guided erector spinae plane block is performed at thoracic (T) level 8. An 18F catheter is placed on both sides of the thoracic vertebra deep into the erector spinae, and a bolus of 20 ml of 0.375% ropivacaine is administered bilaterally. Then, a continuous infusion of 20 ml of 0.375% ropivacaine on each side is followed at a rate of 2 ml/h every 12 hours. The interventions end on day 7 or cease when the patients are discharged from the ICU, dead, or withdraw their consent.
干预措施: Erector spinae plane block (Procedure)
结局指标
主要结局
Sequential Organ Failure Assessment (SOFA) score
时间窗: on the day 7 after enrollment
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. The mininum value is 0 score, and the maximum value is 24 scores. The higher scores mean a worse outcome.
次要结局
- Remission rate of AGI(on the day 3 and 7 after enrollment)
- SOFA score(on the day 3 after enrollment)
- 28-day all-cause mortality(on the day 28 after enrolment)
研究者
Jing Cai, MD
Attending physician
Zhujiang Hospital