The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block

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)

Primary objectives:

To evaluate whether ultrasound-guided erector spinae plane block can reduce the grade of AGI , and improve the cure and remission rate of AGI.

Experimental Group:

On the basis of routine clinical treatment, the ultrasound-guided erector spinae plane block intervention is given. On the first day enrolled, patients are performed with ultrasound-guided erector spinae plane block and cannula will be placed on T8 bilaterally. 0.375% ropivacaine of 20ml is injected separately to both sides with 2ml per hour. Injection is performed twice a day for 7 days or until transferred to the general ward.

Controlled Group:

The patients will receive the clinical routine treatment according of AGI recommended by the 2012 European Society of Critical Care Medicine guidelines, with a uniform nutritional strategy(gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy).

Course: 7 days Sample size: 100 Sites: 1

Primary endpoints:

• the cure rate of AGI
• the remission rate of AGI

Secondary endpoints:

• critical ill scores
• Gastrointestinal function indicators
• The inflammatory indicators
• the lactic acid(Lac)
• cross-sectional area of pyloric antrum(AS) with ultrasound
• width of the colons with abdominal X ray or CT
• the 28-day mortality
• gastrointestinal dysfunction and duration (GIF)

Additional endpoints:

• The length of stay in ICU
• The total days of hospitalization

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Pregnancy.
• 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.