Clinical trial NCT05623722: Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury
Official title: Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Acute Gastrointestinal Injury
Organ Dysfunction Syndrome
Keywords: Sepsis
Acute Gastrointestinal Injury
Organ Dysfunction Syndrome
Erector spinae plane block
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Zhongshan People's Hospital, Guangdong, China
name: Zhongshan Hospital Of Traditional Chinese Medicine
First posted: 2022-11-21
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: on the day 7 after enrollment
Secondary outcomes:
measure: SOFA score
timeFrame: on the day 3 after enrollment
measure: Remission rate of AGI
timeFrame: on the day 3 and 7 after enrollment
measure: 28-day all-cause mortality
timeFrame: on the day 28 after enrolment
Other outcomes:
measure: Indexes of intestinal mucosal damage
timeFrame: on the day 3 and 7 after enrollment
measure: Gut microbiota diversity
timeFrame: on the day 3 and 7 after enrollment
measure: Catecholamine
timeFrame: on the day 3 and 7 after enrollment
Locations:
city: Guangzhou
country: China
facility: Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University
name: Jing Cai
role: PRINCIPAL_INVESTIGATOR
References: