EOI Block for Laparoscopic Gastrostomy

Not Applicable

Recruiting

• Conditions: Gastrostomy

• Registration Number: NCT07119346
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2028-05
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent change in heart rate at surgical incision	At surgical incision (baseline immediately before incision and within 10 minutes after incision).	Post-incision HR - Pre-incision HR) / Pre-incision HR × 100

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl use	From induction of anesthesia to end of surgery.
Percent change in mean arterial pressure at incision	At surgical incision (baseline immediately before incision and within 10 minutes after incision).
Intraoperative max-min heart rate	Intraoperative period (skin incision to end of surgery).
Intraoperative max-min mean arterial pressure	Intraoperative period (skin incision to end of surgery).
ANI time-weighted average outside target (50-80)	From induction of anesthesia to end of anesthesia (arrival to PACU).
Pediatric Pain Profile score	24 hours after surgery.
r-Face, Legs, Activity, Cry, Consolability pain scores	At PACU 15 minutes and 30 minutes; and at 1, 3, 6, and 24 hours after surgery.
analgesia nociception index (ANIm) values in PACU	At 15 and 30 minutes after PACU arrival.
Non-opioid analgesic consumption (mg/kg)	From end of surgery to 24 hours postoperatively.
Analgesic-related adverse effects	Up to 24 hours after surgery.	nausea, vomiting, pruritus
Opioid analgesic consumption (mcg/kg)	From end of surgery to 24 hours postoperatively.

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of