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

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04934904

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Disease	Drug: Ropivacaine injection	N/A

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:

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

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.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)

Masking Description:

This study adopted a randomized, open, blank control design, and did not blind researchers, patients or clinicians.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group 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 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 Names: ropivacaine
No Intervention: Controlled Group the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy

Arm

Intervention/Treatment

Experimental: Experimental Group

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

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 Names:

ropivacaine

No Intervention: Controlled Group

the routine clinical treatment of AGI is given to severe patients, such as gastrointestinal dynamic drugs, traditional Chinese drugs and physical rehabilitation therapy

Outcome Measures

Primary Outcome Measures

the cure rate of AGI [on the day3]
the cure rate of AGI on the day3
the cure rate of AGI [on the day7]
the cure rate of AGI on the day7
the remission rate of AGI [on the day3]
the remission rate of AGI on the day3
the remission rate of AGI [on the day7]
the remission rate of AGI on the day7

Secondary Outcome Measures

Acute Physiology and Chronic Health Evaluation(APACHE II) [on the day 0,1,3 and 7]
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.)
Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [on the day 0,1,3 and 7]
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)
the intraperitoneal pressure(IAP) [on the day 0,1,3 and 7]
Gastrointestinal function indicators
abdominal perfusion pressure(AAP) [on the day 0,1,3 and 7]
Gastrointestinal function indicators
total gastric residual volume(GRVs) [on the day 0,1,3 and 7]
Gastrointestinal function indicators
feeding dose [on the day 0,1,3 and 7]
Gastrointestinal function indicators
Gastrointestinal dysfunction and duration(GIF) [on the day 0,1,3 and 7]
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
Width of the colons [on the day 0,1,3 and 7]
width of the right colons with abdominal X ray or CT
White Blood Cell(WBC) [on the day 0,1,3 and 7]
The inflammatory indicators
Interleukin-6(IL-6) [on the day 0,1,3 and 7]
The inflammatory indicators
Cross-sectional area of pyloric antrum(AS) [on the day 0,1,3 and 7]
cross-sectional area of pyloric antrum(AS) with ultrasound
Lymphocyte (LYM) [on the day 0,1,3 and 7]
The inflammatory indicators
Neutral Granular Cell(NEUT) [on the day 0,1,3 and 7]
The inflammatory indicators
Procalcitonin (PCT) [on the day 0,1,3 and 7]
The inflammatory indicators
Hypersensitive C Reactive Protein(HSCRP) [on the day 0,1,3 and 7]
The inflammatory indicators
The lactic acid(Lac) [on the day 0,1,3 and 7]
the serum level of the lactic
The 28-day mortality [From enrolled to 28 days or the termination date]
the 28-day mortality
The length of stay in ICU [on the day 28 or through study completion]
From the date of ICU admission to transfered out.
The total days of hospitalization [on the day 28 or through study completion]
from hospital admission to hospital discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.