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

Sponsor
Jing Cai, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05623722
Collaborator
Zhongshan People's Hospital, Guangdong, China (Other), Zhongshan Hospital Of Traditional Chinese Medicine (Other)
116
1
2
17.1
6.8

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
  • Procedure: Erector spinae plane block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Plane Block Improves Organ Dysfunction in Septic Patients With Acute Gastrointestinal Injury: a Randomized Clinical Trial
Actual Study Start Date :
Dec 29, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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:
  • Regional nerve block
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 28-day all-cause mortality [on the day 28 after enrolment]

      All-cause mortality on the day 28 from enrollment

    Other Outcome Measures

    1. Indexes of intestinal mucosal damage [on the day 3 and 7 after enrollment]

      D-lactic acid,intestinal fatty acid binding protein in the serum

    2. 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.

    3. 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

    4. Catecholamine [on the day 3 and 7 after enrollment]

      Epinephrine,norepinephrine, dopamine and vanillylmandelic acid in the serum.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Jing Cai, MD, Attending physician, Zhujiang Hospital
    ClinicalTrials.gov Identifier:
    NCT05623722
    Other Study ID Numbers:
    • 2022LX0084_GY
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Jan 6, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jing Cai, MD, Attending physician, Zhujiang Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 6, 2023