Erector spinae plane block for septic patients with gastrointestinal injury

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

This study tests whether a specific pain relief technique can help septic patients with gut injuries recover better while they are in the ICU.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05623722 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the erector spinae plane block in improving organ dysfunction in septic patients suffering from acute gastrointestinal injury. It is a multicenter, parallel-group, open-label, randomized controlled trial designed to assess the impact of this intervention on patient outcomes. The study aims to build on previous findings that suggested this technique may enhance recovery in similar patient populations. Participants will be monitored for improvements in organ function during their ICU stay.

Who should consider this trial

Good fit: Ideal candidates are septic patients aged over 18 with acute gastrointestinal injury grades II or III who are expected to remain in the ICU for at least three days.

Not a fit: Patients with severe hemodynamic instability, primary gastrointestinal disorders requiring surgery, or contraindications to the erector spinae plane block may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve recovery outcomes for septic patients with gastrointestinal injuries.

How similar studies have performed: Previous studies have indicated that the erector spinae plane block may improve organ dysfunction in similar patient populations, suggesting a promising avenue for further investigation.

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;

Where this trial is running

Guangzhou, Guangdong

• Department of Intensive Care Medicine of Zhujiang Hospital,Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Jing Cai — Department of Intensive Care Medicine, Zhujiang Hospital, Southern Medical University
• Study coordinator: Jing Cai, MD

Conditions Sepsis; Acute Gastrointestinal Injury; Organ Dysfunction Syndrome; Erector spinae plane block