NCT07119346

EOI Block for Laparoscopic Gastrostomy

Effect of Ultrasound-guided External Oblique Intercostal Fascial Plane Block in Pediatric Patients Undergoing Laparoscopic Gastrostomy: A Prospective Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate the efficacy of ultrasound-guided external oblique intercostal fascial plane (EOI) block in reducing intraoperative and postoperative pain in pediatric patients undergoing laparoscopic gastrostomy under general anesthesia. Forty patients aged 3-18 years will be randomly allocated to receive either bilateral EOI block with 0.25% ropivacaine or sham block with normal saline. Primary outcome is percent change in heart rate at surgical incision. Secondary outcomes include intraoperative fentanyl use, perioperative analgesic requirements, postoperative pain scores (r-Face, Legs, Activity, Cry, Consolability(r-FLACC) and Pediatric Pain Profile), Analgesia Nociception Index values, and analgesia-related adverse events.

Conditions

• Gastrostomy

Interventions

Type	Name	Description
PROCEDURE	EOI block	EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance
PROCEDURE	sham block	Sham block with equal volume of normal saline bilaterally under ultrasound guidance

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: South Korea