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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623722
• Other study ID #: 2022LX0084_GY
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2022
• Est. completion date: June 2024

Study information

• Verified date: January 2023
• Source: Zhujiang Hospital
• Contact: Jing Cai, MD
• Phone: +86-02062782927
• Email: caijing78[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Organ Dysfunction Syndrome
• Sepsis
• Wounds and Injuries

Intervention

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

Country	Name	City	State
China	Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Jing Cai, MD	Zhongshan Hospital Of Traditional Chinese Medicine, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Indexes of intestinal mucosal damage	D-lactic acid,intestinal fatty acid binding protein in the serum	on the day 3 and 7 after enrollment
Other	Gut microbiota diversity	The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.	on the day 3 and 7 after enrollment
Other	Inflammatory indexes	Inflammatory indexes including TNF-a,IL-6,IL-1ß,IL-8,IL-10,IL-4 in the serum and feces	on the day 3 and 7 after enrollment
Other	Catecholamine	Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.	on the day 3 and 7 after enrollment
Primary	Sequential Organ Failure Assessment (SOFA) score	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.	on the day 7 after enrollment
Secondary	SOFA score	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.	on the day 3 after enrollment
Secondary	Remission rate of AGI	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.	on the day 3 and 7 after enrollment
Secondary	28-day all-cause mortality	All-cause mortality on the day 28 from enrollment	on the day 28 after enrolment