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

NCT ID: NCT04934904

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-09-15

Brief Summary

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.

Detailed 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

Conditions

Gastrointestinal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine injection

Intervention Type: DRUG

On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.

Controlled Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ropivacaine injection

On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.

Intervention Type: DRUG

Other Intervention Names

ropivacaine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hua Wang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2020-KY-032-03

Identifier Type: -

Identifier Source: org_study_id