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

Study Overview
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Brief Summary
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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
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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: the cure rate of AGI the remission rate of AGI Secondary endpoints: critical ill scores Gastrointestinal function indicators The inflammatory indicators the lactic acid(Lac) cross-sectional area of pyloric antrum(AS) with ultrasound width of the colons with abdominal X ray or CT the 28-day mortality gastrointestinal dysfunction and duration (GIF) Additional endpoints: The length of stay in ICU The total days of hospitalization

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

Conditions
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Gastrointestinal Disease

Intervention / Treatment
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* Drug: Ropivacaine injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Age 18-80 years. Expected length of stay longer than 3 days. Exclusion Criteria: 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. Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker. Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation. Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history. Neuromuscular disorders. Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders. Pregnancy. Brain dead. Malignant tumor, or end-stage cachexia. With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization. Allergy to local anesthetics. Significant abnormalities in blood coagulation parameters. Without written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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. | Drug: Ropivacaine injection<br>* 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.<br>* Other names: ropivacaine;|
| No Intervention: Controlled Group<br>the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cure rate of AGI | the cure rate of AGI on the day3 | on the day3 | 
| the cure rate of AGI | the cure rate of AGI on the day7 | on the day7 | 
| the remission rate of AGI | the remission rate of AGI on the day3 | on the day3 | 
| the remission rate of AGI | the remission rate of AGI on the day7 | on the day7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Physiology and Chronic Health Evaluation(APACHE II) | measuring endpoints include: body temperature mean arterial pressure (MAP) heart rate (HR) respiratory rate (RR) fraction of inspiration O2 (FIO2) potential of hydrogen (PH) Na+ K+ serum creatinine (SCr) hematocrit (Hct%) white blood cell (WBC) Age immunosuppression before/after surgery or serious organ dysfunction (Higher score means a worse outcome.) | on the day 0,1,3 and 7 | 
| Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score | SOFA score evaluate status of the following organ systems separately: (Higher score means a worse outcome.) Respiration Partial Pressure of Oxygen/Fraction of Inspiration O2 (PaO2/FiO2) Coagulation Platelets Liver Bilirubin Circulatory Mean arterial pressure Central Nervous System Glasgow coma score Renal Creatinine (or urine output) | on the day 0,1,3 and 7 | 
| the intraperitoneal pressure(IAP) | Gastrointestinal function indicators | on the day 0,1,3 and 7 | 
| abdominal perfusion pressure(AAP) | Gastrointestinal function indicators | on the day 0,1,3 and 7 | 
| total gastric residual volume(GRVs) | Gastrointestinal function indicators | on the day 0,1,3 and 7 | 
| feeding dose | Gastrointestinal function indicators | on the day 0,1,3 and 7 | 
| Gastrointestinal dysfunction and duration(GIF) | fasting(score 1 point) reflux(score 2 points) gastrointestinal decompression(1 point) Gastric retention(2 points) abdominal distension(2 points) abdominal pain(2 points) diarrhea(2 points) hypoactive bowel sounds(1 point) bowel sounds disappear(2 points) constipation(2 points) The mentioned indicators will be combined to report GIF in score. Grade 0 (Normal) : 0 score Grade 1 (Mild) : 1 4 score Grade 2 (Medium) : 5 9 score Grade 3 (Serious) : >10 score | on the day 0,1,3 and 7 | 
| Width of the colons | width of the right colons with abdominal X ray or CT | on the day 0,1,3 and 7 | 
| White Blood Cell(WBC) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| Interleukin-6(IL-6) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| Cross-sectional area of pyloric antrum(AS) | cross-sectional area of pyloric antrum(AS) with ultrasound | on the day 0,1,3 and 7 | 
| Lymphocyte (LYM) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| Neutral Granular Cell(NEUT) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| Procalcitonin (PCT) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| Hypersensitive C Reactive Protein(HSCRP) | The inflammatory indicators | on the day 0,1,3 and 7 | 
| The lactic acid(Lac) | the serum level of the lactic | on the day 0,1,3 and 7 | 
| The 28-day mortality | the 28-day mortality | From enrolled to 28 days or the termination date | 
| The length of stay in ICU | From the date of ICU admission to transfered out. | on the day 28 or through study completion | 
| The total days of hospitalization | from hospital admission to hospital discharge. | on the day 28 or through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute gastrointestinal injury, Erector spinal muscle plane block, Ropivacaine