Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury

Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial

This study is a prospective, multicenter, parallel-group, open-label, randomized controlled clinical trial. Sepsis is defined as organ dysfunction induced by infections. And sepsis and gastrointestinal injury can be the leading cause for each other. Our previous study showed erector spinae plane block improved the organ dysfunctions in patients with AGI. The aim of the clinical trial is to investigate erector pinae plane block improves the organ dysfunction in septic patients with acute gastrointestinal injury.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Gastrointestinal Injury; Organ Dysfunction Syndrome
• Intervention / Treatment: Procedure: Erector spinae plane block

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jing Cai, MD; Phone Number: +86-02062782927; Email: caijing78@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University
      • Contact: Ping Chang, M.D.PhD; Phone Number: +86-02062782927; Email: changp963@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Septic patients with acute gastrointestinal injury grade II or III;
• Age over 18 years;
• Expected to stay in the ICU for at least 3 days or longer;

Exclusion Criteria:

• Mean arterial pressure less than 65 mmHg after fluid resuscitation, or requirement for an intravenous norepinephrine dose of greater than 0.5 µg/kg/min to maintain a normal mean arterial pressure;
• Heart rates less than 50 beats/min, or concomitant with moderate-to-severe atrioventricular block without a pacemaker;
• Contraindications for erector spinae plane blocks, including infection of the puncture site, spinal diseases or immobilization;
• Primary gastrointestinal disorders requiring a surgical procedure, such as mechanical intestinal obstruction, massive gastrointestinal hemorrhage, and gastrointestinal perforation;
• Gastrointestinal operation within one week before enrollment;
• Neuromuscular disorders;
• Coagulation abnormalities：activated prothrombin time or prothrombin time is prolonged with 2 folds, or platelet count less than 50×109/L;
• End-stage malignant tumor or cachexia;
• History of allergy to amide anesthetics;
• Known pregnancy;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU. The interventions end on day 7 or cease when the patients are discharged from the ICU, dead, or withdraw their consent.
Experimental: Erector Spinae Plane Block Group; Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU.; Ultrasound-guided erector spinae plane block is performed at thoracic (T) level 8. An 18F catheter is placed on both sides of the thoracic vertebra deep into the erector spinae, and a bolus of 20 ml of 0.375% ropivacaine is administered bilaterally. Then, a continuous infusion of 20 ml of 0.375% ropivacaine on each side is followed at a rate of 2 ml/h every 12 hours. The interventions end on day 7 or cease when the patients are discharged from the ICU, dead, or withdraw their consent.	Procedure: Erector spinae plane block; Ultrasound-guided erector spinae plane block is performed at thoracic (T) level 8. An 18F catheter is placed on both sides of the thoracic vertebra deep into the erector spinae, and a bolus of 20 ml of 0.375% ropivacaine is administered bilaterally. Then, a continuous infusion of 20 ml of 0.375% ropivacaine on each side is followed at a rate of 2 ml/h every 12 hours. The intervention ends on day 7 or ceases when the patient is discharged from the ICU, died, or withdrew their consent.; Other Names: Regional nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sequential Organ Failure Assessment (SOFA) score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. The mininum value is 0 score, and the maximum value is 24 scores. The higher scores mean a worse outcome.	on the day 7 after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score. The mininum value is 0 score, and the maximum value is 24 scores. The higher scores mean a worse outcome.	on the day 3 after enrollment
Remission rate of AGI	The remission of AGI is defined as a decrease of more than one grade in AGI grades. The remission rate is the percentage of remission in the same cohort.	on the day 3 and 7 after enrollment
28-day all-cause mortality	All-cause mortality on the day 28 from enrollment	on the day 28 after enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indexes of intestinal mucosal damage	D-lactic acid，intestinal fatty acid binding protein in the serum	on the day 3 and 7 after enrollment
Gut microbiota diversity	The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.	on the day 3 and 7 after enrollment
Catecholamine	Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.	on the day 3 and 7 after enrollment

Collaborators and Investigators

• Sponsor: Jing Cai, MD
• Collaborators: Zhongshan People's Hospital, Guangdong, China; Zhongshan Hospital Of Traditional Chinese Medicine
• Investigators: Principal Investigator: Jing Cai, Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Sepsis; Erector spinae plane block; Acute Gastrointestinal Injury; Organ Dysfunction Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: 2022LX0084_GY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication are to be shared.
• IPD Sharing Time Frame: This are to be provided as a date relative to the time when summary data are published.
• IPD Sharing Access Criteria: The data will be made available upon reasonable request by the corresponding author. A proposal with a detailed description of the study objectives and a plan for statistical analysis will be required for the evaluation of the reasonability of requests. Additional materials may also be required during the process of request evaluation. The data of deidentified participants will be provided after approval by the corresponding authors and the Zhujiang Hospital of Southern Medical University.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No