The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block
Condition: Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

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
    

Intervention name(s): Ropivacaine injection
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental Group:
On the basis of the clinical routine treatment of AGI in severe patients (gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy), the ultrasound-guided erector spinae plane block intervention is given.
Controlled Group:
Normal Treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute gastrointestinal injury; Erector spinal muscle plane block; Ropivacaine