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

Not Applicable

Recruiting

• Conditions: Acute Gastrointestinal Injury; Organ Dysfunction Syndrome; Sepsis
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT05623722
• Lead Sponsor: Jing Cai, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-13
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-21
• Study Start: 2022-12-29
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block Group	Erector spinae plane block	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.

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score	on the day 7 after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
28-day all-cause mortality	on the day 28 after enrolment	All-cause mortality on the day 28 from enrollment
Remission rate of AGI	on the day 3 and 7 after enrollment	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.
SOFA score	on the day 3 after enrollment	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.

Trial Locations

Locations (1)

Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China