Transversalis Fascia Plane Block for Iliac Bone Graft in Children

NCT ID: NCT06403462

Last Updated: 2026-01-14

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-07

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to determine which method is more effective in postoperative pain control in children undergoing iliac bone grafting for alveoloplasty under general anesthesia: ultrasound-guided transverse abdominal blockade or transversalis fascia plane block

Detailed Description

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Conditions

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Postoperative Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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transversus abdominis plane block

Group Type ACTIVE_COMPARATOR

transversus abdominis plane block

Intervention Type PROCEDURE

ultrasound guidance lateral transversus abdominis plane block after iliac bone graft

transversalis fascial plane block

Group Type EXPERIMENTAL

transversalis fascial plane block

Intervention Type PROCEDURE

ultrasound guidance transversalis fascial plane block after iliac bone graft

Interventions

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transversalis fascial plane block

ultrasound guidance transversalis fascial plane block after iliac bone graft

Intervention Type PROCEDURE

transversus abdominis plane block

ultrasound guidance lateral transversus abdominis plane block after iliac bone graft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty

Exclusion Criteria

* Patients with diseases that affect pain sensitivity differently from the general population (e.g., congenital insensitivity to pain with anhidrosis, complex regional pain syndrome, etc.)
* Cases where there is difficulty in expressing pain (due to cognitive or functional deficits, or limited ability to communicate)
* Unstable vital signs (heart rate, blood pressure)
* Common contraindications for Ropivacaine: 1) Patients with a history of hypersensitivity to this drug or other amide local anesthetics, 2) Patients in a state of major bleeding or shock, 3) Patients with inflammation at or around the site of administration, 4) Patients with sepsis, 5) Intravenous regional anesthesia (Bier block)
* History of allergy to opioid medications
* Severe renal impairment (Creatinine \>3.0mg/dL)
* Severe liver function abnormalities (aspartate transaminase \> 120 unit/L, alanine aminotransferase \> 120 unit/L)
* Peripheral nervous system disorders
* Other cases deemed unsuitable by the researcher
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

Countries

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South Korea

Other Identifiers

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H-2311-167-1488

Identifier Type: -

Identifier Source: org_study_id

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