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

NCT04934904 | Completed DMC

• 1 other identifier: 2020-KY-032-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease

Keywords

Acute gastrointestinal injury; Erector spinal muscle plane block; Ropivacaine

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• Acute Physiology and Chronic Health Evaluation(APACHE II)

  on the day 0,1,3 and 7

• Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score

  on the day 0,1,3 and 7

• the intraperitoneal pressure(IAP)

  on the day 0,1,3 and 7

• abdominal perfusion pressure(AAP)

  on the day 0,1,3 and 7

• total gastric residual volume(GRVs)

  on the day 0,1,3 and 7

Study Arms (2)

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.

Drug: Ropivacaine injection

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

Interventions

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.

Also known as: ropivacaine

Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hua Wang, MD,PhD

  Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study adopted a randomized, open, blank control design, and did not blind researchers, patients or clinicians.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 22, 2021
• Study Start: August 1, 2019
• Primary Completion: August 23, 2021
• Study Completion: September 15, 2021
• Last Updated: September 9, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)