Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 28-day all-cause mortality [on the day 28 after enrolment]
All-cause mortality on the day 28 from enrollment
Other Outcome Measures
- Indexes of intestinal mucosal damage [on the day 3 and 7 after enrollment]
D-lactic acid,intestinal fatty acid binding protein in the serum
- Gut microbiota diversity [on the day 3 and 7 after enrollment]
The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.
- Inflammatory indexes [on the day 3 and 7 after enrollment]
Inflammatory indexes including TNF-α,IL-6,IL-1β,IL-8,IL-10,IL-4 in the serum and feces
- Catecholamine [on the day 3 and 7 after enrollment]
Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Septic patients with acute gastrointestinal injury grade II or III;
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Age over 18 years;
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Expected to stay in the ICU for at least 3 days or longer;
Exclusion Criteria:
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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;
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Heart rates less than 50 beats/min, or concomitant with moderate-to-severe atrioventricular block without a pacemaker;
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Contraindications for erector spinae plane blocks, including infection of the puncture site, spinal diseases or immobilization;
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Primary gastrointestinal disorders requiring a surgical procedure, such as mechanical intestinal obstruction, massive gastrointestinal hemorrhage, and gastrointestinal perforation;
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Gastrointestinal operation within one week before enrollment;
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Neuromuscular disorders;
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Coagulation abnormalities:activated prothrombin time or prothrombin time is prolonged with 2 folds, or platelet count less than 50×109/L;
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End-stage malignant tumor or cachexia;
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History of allergy to amide anesthetics;
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Known pregnancy;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University | Guangzhou | Guangdong | China | 510282 |
Sponsors and Collaborators
- Jing Cai, MD
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022LX0084_GY