EOI Block for Laparoscopic Gastrostomy

NCT ID: NCT07119346

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2028-05-31

Brief Summary

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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

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Conditions

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Gastrostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EOI block group

Group Type EXPERIMENTAL

EOI block

Intervention Type PROCEDURE

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

control group

Group Type SHAM_COMPARATOR

sham block

Intervention Type PROCEDURE

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

Interventions

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EOI block

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

Intervention Type PROCEDURE

sham block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jin-Tae Kim, M.D.,Ph.D.

Role: primary

0220723664 ext. 82

Other Identifiers

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2505-109-1643

Identifier Type: -

Identifier Source: org_study_id

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