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

Gastrointestinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04934904
• Other study ID #: 2020-KY-032-03
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2021
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 15, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Age 18-80 years.

3. Expected length of stay longer than 3 days.

Exclusion Criteria:

1. 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.

2. Heart rates are less than 50 beats per minute or moderate and severe atrioventricular block without pacemaker.

3. Primary gastrointestinal disease such as mechanical intestinal obstruction, massive hemorrhage of gastrointestinal tract and gastrointestinal perforation.

4. Severe trauma of chest, abdomen or back. gastrointestinal tract surgery history.

5. Neuromuscular disorders.

6. Drug addiction, alcohol abuse, opioid or amphetamine dependence, or mental disorders.

7. Pregnancy.

8. Brain dead.

9. Malignant tumor, or end-stage cachexia.

10. With contraindications of the erector spinae plane block (ESPB), such as local infection, Spinal diseases or immobilization.

11. Allergy to local anesthetics.

12. Significant abnormalities in blood coagulation parameters.

13. Without written informed consent.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the cure rate of AGI	the cure rate of AGI on the day3	on the day3
Primary	the cure rate of AGI	the cure rate of AGI on the day7	on the day7
Primary	the remission rate of AGI	the remission rate of AGI on the day3	on the day3
Primary	the remission rate of AGI	the remission rate of AGI on the day7	on the day7
Secondary	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
Secondary	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
Secondary	the intraperitoneal pressure(IAP)	Gastrointestinal function indicators	on the day 0,1,3 and 7
Secondary	abdominal perfusion pressure(AAP)	Gastrointestinal function indicators	on the day 0,1,3 and 7
Secondary	total gastric residual volume(GRVs)	Gastrointestinal function indicators	on the day 0,1,3 and 7
Secondary	feeding dose	Gastrointestinal function indicators	on the day 0,1,3 and 7
Secondary	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
Secondary	Width of the colons	width of the right colons with abdominal X ray or CT	on the day 0,1,3 and 7
Secondary	White Blood Cell(WBC)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	Interleukin-6(IL-6)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	Cross-sectional area of pyloric antrum(AS)	cross-sectional area of pyloric antrum(AS) with ultrasound	on the day 0,1,3 and 7
Secondary	Lymphocyte (LYM)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	Neutral Granular Cell(NEUT)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	Procalcitonin (PCT)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	Hypersensitive C Reactive Protein(HSCRP)	The inflammatory indicators	on the day 0,1,3 and 7
Secondary	The lactic acid(Lac)	the serum level of the lactic	on the day 0,1,3 and 7
Secondary	The 28-day mortality	the 28-day mortality	From enrolled to 28 days or the termination date
Secondary	The length of stay in ICU	From the date of ICU admission to transfered out.	on the day 28 or through study completion
Secondary	The total days of hospitalization	from hospital admission to hospital discharge.	on the day 28 or through study completion