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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:
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 â…¡ 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:
Secondary endpoints:
Additional endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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. |
|
| Controlled Group | No Intervention | the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection | 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. |
| 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 |
| 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.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hua Wang, MD,PhD | Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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.
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This study adopted a randomized, open, blank control design, and did not blind researchers, patients or clinicians.
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| 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.)
| 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) |
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 |
| D000588 |
| Amines |