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RECRUITING
NCT07119346
NA

EOI Block for Laparoscopic Gastrostomy

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08

Completion Date

2028-05

Last Updated

2025-08-13

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea