RecruitingNot ApplicableNCT07119346

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


Sponsor

Seoul National University Hospital

Enrollment

40 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria2

  • Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital
  • Age ≥3 and <18 years

Exclusion Criteria4

  • Unstable vital signs
  • Contraindications to ropivacaine or opioids
  • Severe hepatic or renal dysfunction
  • Other investigator-determined ineligibility

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Interventions

PROCEDUREEOI block

EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance

PROCEDUREsham block

Sham block with equal volume of normal saline bilaterally under ultrasound guidance


Locations(1)

Seoul National University Children's Hospital

Seoul, South Korea

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NCT07119346


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