Clinical trial NCT04934904: The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block
Official title: The Treatment of Acute Gastrointestinal Injury Via Ultrasound-guided Erector Spinae Plane Block - a Prospective, Single-center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Keywords: Acute gastrointestinal injury
Erector spinal muscle plane block
Ropivacaine
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: the cure rate of AGI
timeFrame: on the day3
measure: the cure rate of AGI
timeFrame: on the day7
measure: the remission rate of AGI
timeFrame: on the day3
measure: the remission rate of AGI
timeFrame: on the day7
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation(APACHE II)
timeFrame: on the day 0,1,3 and 7
measure: Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score
timeFrame: on the day 0,1,3 and 7
measure: the intraperitoneal pressure(IAP)
timeFrame: on the day 0,1,3 and 7
measure: abdominal perfusion pressure(AAP)
timeFrame: on the day 0,1,3 and 7
measure: total gastric residual volume(GRVs)
timeFrame: on the day 0,1,3 and 7
measure: feeding dose
timeFrame: on the day 0,1,3 and 7
measure: Gastrointestinal dysfunction and duration(GIF)
timeFrame: on the day 0,1,3 and 7
measure: Width of the colons
timeFrame: on the day 0,1,3 and 7
measure: White Blood Cell(WBC)
timeFrame: on the day 0,1,3 and 7
measure: Interleukin-6(IL-6)
timeFrame: on the day 0,1,3 and 7
measure: Cross-sectional area of pyloric antrum(AS)
timeFrame: on the day 0,1,3 and 7
measure: Lymphocyte (LYM)
timeFrame: on the day 0,1,3 and 7
measure: Neutral Granular Cell(NEUT)
timeFrame: on the day 0,1,3 and 7
measure: Procalcitonin (PCT)
timeFrame: on the day 0,1,3 and 7
measure: Hypersensitive C Reactive Protein(HSCRP)
timeFrame: on the day 0,1,3 and 7
measure: The lactic acid(Lac)
timeFrame: on the day 0,1,3 and 7
measure: The 28-day mortality
timeFrame: From enrolled to 28 days or the termination date
measure: The length of stay in ICU
timeFrame: on the day 28 or through study completion
measure: The total days of hospitalization
timeFrame: on the day 28 or through study completion
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
name: Hua Wang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: