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

NCT05623722 | Recruiting DMC

• 1 other identifier: 2022LX0084_GY
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Acute Gastrointestinal Injury; Organ Dysfunction Syndrome

Keywords

Sepsis; Acute Gastrointestinal Injury; Organ Dysfunction Syndrome; Erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• SOFA score

  on the day 3 after enrollment

• Remission rate of AGI

  on the day 3 and 7 after enrollment

• 28-day all-cause mortality

  on the day 28 after enrolment

Other Outcomes (3)

• Indexes of intestinal mucosal damage

  on the day 3 and 7 after enrollment

• Gut microbiota diversity

  on the day 3 and 7 after enrollment

• Catecholamine

  on the day 3 and 7 after enrollment

Study Arms (2)

Control Group

NO INTERVENTION

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.

Erector Spinae Plane Block Group

EXPERIMENTAL

1. Patients receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU. 2. 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

Interventions

Erector spinae plane block PROCEDURE

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.

Also known as: Regional nerve block

Erector Spinae Plane Block Group

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jing Cai, MD: lead
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Zhongshan Hospital Of Traditional Chinese Medicine: collaborator

Study Sites (1)

Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Cai

  Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Cai, MD

CONTACT

+86-02062782927; caijing78@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician

Model Details: Participants are assigned to two groups in parallel. All patients in both groups receive the same administration of acute gastrointestinal injury and enteral nutrition strategy according to the guidelines, and the routine practice of the ICU.For patients in the erector spinae plane block group, 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, died, or withdrew their consent.

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: December 29, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: This are to be provided as a date relative to the time when summary data are published.
• 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.

Locations

CN (1)