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NCT Number: NCT05623722

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510282, China

Location status: Recruiting

Location contact

Ping Chang, M.D.PhD

CONTACT

[email protected]

+86-02062782927

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Primary outcomes

  1. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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 outcomes

  1. SOFA score

    Time frame: 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

    Time frame: 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

    Time frame: on the day 28 after enrolment

    All-cause mortality on the day 28 from enrollment

Other outcomes

  1. Indexes of intestinal mucosal damage

    Time frame: on the day 3 and 7 after enrollment

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

  2. Gut microbiota diversity

    Time frame: on the day 3 and 7 after enrollment

    The fecal DNA is obtained from peri-rectal swabs and analyzed for gut microbiota diversity.

  3. Catecholamine

    Time frame: on the day 3 and 7 after enrollment

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Cai, MD

CONTACT

[email protected]

+86-02062782927

Sponsors and collaborators

Lead sponsor

Jing Cai, MD

Other

Collaborators

  • Zhongshan Hospital Of Traditional Chinese Medicine
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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