EOI Block for Laparoscopic Gastrostomy

NCT07119346 | Recruiting

• 1 other identifier: 2505-109-1643
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy

Outcome Measures

Primary Outcomes (1)

• Percent change in heart rate at surgical incision

  Post-incision HR - Pre-incision HR) / Pre-incision HR × 100

  At surgical incision (baseline immediately before incision and within 10 minutes after incision).

Secondary Outcomes (11)

• 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).

Study Arms (2)

EOI block group

EXPERIMENTAL

Procedure: EOI block

control group

SHAM COMPARATOR

Procedure: sham block

Interventions

EOI block PROCEDURE

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

EOI block group

sham block PROCEDURE

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

control group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

KR (1)