RECRUITINGINTERVENTIONAL

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

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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; Who Should NOT Join This Trial: - 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; Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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;

Treatments Being Tested

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.

Locations (1)

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

Guangzhou, Guangdong, China