EOI Block for Laparoscopic Gastrostomy

Seoul National University

Status: Enrolling

Conditions: Gastrostomy

Treatments: Procedure: EOI block; Procedure: sham block

Study type: Interventional

Funder types: Other

Identifiers

NCT07119346

2505-109-1643

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for laparoscopic gastrostomy at Seoul National University Children's Hospital

Age ≥3 and <18 years

Exclusion criteria

• Unstable vital signs

Contraindications to ropivacaine or opioids

Severe hepatic or renal dysfunction

Other investigator-determined ineligibility

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

EOI block group

Experimental group

Treatment:

Procedure: EOI block

control group

Sham Comparator group

Treatment:

Procedure: sham block