Transversalis Fascia Plane Block for Iliac Bone Graft in Children

Seoul National University Hospital40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain, Acute

Interventions

transversalis fascial plane blockPROCEDURE

ultrasound guidance transversalis fascial plane block after iliac bone graft

transversus abdominis plane blockPROCEDURE

ultrasound guidance lateral transversus abdominis plane block after iliac bone graft

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Children's Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

total consumption of opioid (mcg/kg)

total opioid consumption at 24 hours after the end of surgery

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

Secondary Outcomes

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

Time frame: 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

Time frame: 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).

Time frame: at 30 minutes 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.

Time frame: within 24 hours after the end of surgery

Satisfaction score

Patient satisfaction score (0-100 points, with 100 being very satisfied and 0 being very dissatisfied).

Time frame: at 24 hours after the end of surgery

Sleep quality score

Data from ClinicalTrials.gov

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