EOI Block for Laparoscopic Gastrostomy

August 11, 2025 updated by: Jin-Tae Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: control group
Procedure: sham block
Sham block with equal volume of normal saline bilaterally under ultrasound guidance
Experimental: EOI block group
Procedure: EOI block
EOI block with 0.25% ropivacaine 1 mL/kg (max 40 mL) bilaterally under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in heart rate at surgical incision
Time Frame: At surgical incision (baseline immediately before incision and within 10 minutes after 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

August 11, 2025

First Submitted That Met QC Criteria

August 11, 2025

First Posted (Actual)

August 13, 2025

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2505-109-1643

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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