NCT04934904

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

The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-08-23
• Completion: 2021-09-15
• First posted: 2021-06-22
• Last updated: 2022-09-09

Locations

1 site across 1 country: China