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

Zhujiang Hospital

Status: Completed

Conditions: Gastrointestinal Disease

Treatments: Drug: Ropivacaine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04934904

2020-KY-032-03

Details and patient eligibility

About

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.

Full description

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:

1. the cure rate of AGI
2. the remission rate of AGI

Secondary endpoints:

1. critical ill scores
2. Gastrointestinal function indicators
3. The inflammatory indicators
4. the lactic acid(Lac)
5. cross-sectional area of pyloric antrum(AS) with ultrasound
6. width of the colons with abdominal X ray or CT
7. the 28-day mortality
8. gastrointestinal dysfunction and duration (GIF)

Additional endpoints:

1. The length of stay in ICU
2. The total days of hospitalization

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Age 18-80 years.
3. Expected length of stay longer than 3 days.

Exclusion criteria

1. 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.
2. Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.
3. Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.
4. Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.
5. Neuromuscular disorders.
6. Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.
7. Pregnancy.
8. Brain dead.
9. Malignant tumor, or end-stage cachexia.
10. With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.
11. Allergy to local anesthetics.
12. Significant abnormalities in blood coagulation parameters.
13. Without written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Drug: Ropivacaine injection

Controlled Group

No Intervention group

Description:

the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy