Transversalis Fascia Plane Block for Iliac Bone Graft in Children

NCT06403462 | Completed

• 1 other identifier: H-2311-167-1488
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• total consumption of opioid (mcg/kg)

  total opioid consumption at 24 hours after the end of surgery

  from the end of surgery up to 24 hours later

Secondary Outcomes (6)

• Postoperative Pain score

  at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery

• Total consumption of non-opioid (mg/kg)

  within 24 hours after the end of surgery

• Cold sensation

  at 30 minutes after the end of surgery

• The incidence of side effects of analgesic medications (percent)

  within 24 hours after the end of surgery

• Satisfaction score

  at 24 hours after the end of surgery

Study Arms (2)

transversus abdominis plane block

ACTIVE COMPARATOR

Procedure: transversus abdominis plane block

transversalis fascial plane block

EXPERIMENTAL

Procedure: transversalis fascial plane block

Interventions

transversalis fascial plane block PROCEDURE

ultrasound guidance transversalis fascial plane block after iliac bone graft

transversalis fascial plane block

transversus abdominis plane block PROCEDURE

ultrasound guidance posterior transversus abdominis plane block after iliac bone graft

transversus abdominis plane block

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 7, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

KR (1)