Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04934904
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
Study:
NCT04934904
Study Brief:
Protocol Section:
NCT04934904