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Recruiting NCT05623722

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

No phase Interventional Sepsis Acute Gastrointestinal Injury Organ Dysfunction Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector spinae plane block.
Who it may be relevant to
Registry conditions: Sepsis, Acute Gastrointestinal Injury, Organ Dysfunction Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Sequential Organ Failure Assessment (SOFA) score [Time frame: on the day 7 after enrollment]
Secondary outcome measures (3)
  • SOFA score [Time frame: on the day 3 after enrollment]
  • Remission rate of AGI [Time frame: on the day 3 and 7 after enrollment]
  • 28-day all-cause mortality [Time frame: on the day 28 after enrolment]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University — Guangzhou

Identifiers

NCT: NCT05623722 · 2022LX0084_GY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗