Skip to main content
OpenTrials
Completed

NCT Number: NCT06403462

Transversalis Fascia Plane Block for Iliac Bone Graft in Children

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Children's Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transversalis fascial plane block

Procedure

ultrasound guidance transversalis fascial plane block after iliac bone graft

transversus abdominis plane block

Procedure

ultrasound guidance posterior transversus abdominis plane block after iliac bone graft

Primary outcomes

  1. total consumption of opioid (mcg/kg)

    Time frame: from the end of surgery up to 24 hours later

    total opioid consumption at 24 hours after the end of surgery

Secondary outcomes

  1. Postoperative Pain score

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

    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

  2. Total consumption of non-opioid (mg/kg)

    Time frame: within 24 hours after the end of surgery

    Non-opioid analgesics usage per body weight within 24 hours after surgery

  3. Cold sensation

    Time frame: at 30 minutes after the end of surgery

    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).

  4. The incidence of side effects of analgesic medications (percent)

    Time frame: within 24 hours after the end of surgery

    Analgesic-related side effects (nausea, vomiting, constipation, pruritis, dizziness, dry mouth, somnolence, etc.) within 24 hours after surgery.

  5. Satisfaction score

    Time frame: at 24 hours after the end of surgery

    Patient satisfaction score (0-10 points, with 10 being very satisfied and 0 being very dissatisfied).

  6. Sleep quality score

    Time frame: at 24 hours after the end of surgery

    Quality of sleep on the day of operation (satisfaction score, 0-10 points, with 10 being very satisfied and 0 being very dissatisfied).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2024
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.