Transversalis Fascia Plane Block for Iliac Bone Graft in Children

Comparison Between Ultrasound-guided Transversus Abdominis Plane and Transversalis Fascia Plane Block for Pediatric Patients Undergoing Alveoloplasty With Iliac Bone Graft: a Prospective Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Procedure: transversalis fascial plane block; Procedure: transversus abdominis plane block

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 110-744
    • Seoul National University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: transversalis fascial plane block	Procedure: transversalis fascial plane block; ultrasound guidance transversalis fascial plane block after iliac bone graft
Active Comparator: transversus abdominis plane block	Procedure: transversus abdominis plane block; ultrasound guidance posterior transversus abdominis plane block after iliac bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain score	Pain scores is assessed by Numerical Rating Scale, which requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable	at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery
Total consumption of non-opioid (mg/kg)	Non-opioid analgesics usage per body weight within 24 hours after surgery	within 24 hours after the end of surgery
The incidence of side effects of analgesic medications (percent)	Analgesic-related side effects (nausea, vomiting, constipation, pruritis, dizziness, dry mouth, somnolence, etc.) within 24 hours after surgery.	within 24 hours after the end of surgery
Cold sensation	Evaluation of the distribution of lost cold sensation in the skin in the recovery room (Dermatomal distribution of the loss of cold sensation using an alcohol swab at post-anesthesia care unit, assessed by a blinded assessor in the Post Anesthesia Care Unit).	at 30 minutes after the end of surgery
Satisfaction score	Patient satisfaction score (0-10 points, with 10 being very satisfied and 0 being very dissatisfied).	at 24 hours after the end of surgery
Sleep quality score	Quality of sleep on the day of operation (satisfaction score, 0-10 points, with 10 being very satisfied and 0 being very dissatisfied).	at 24 hours after the end of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: H-2311-167-1488

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No