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

Seoul National University Hospital1 site in 1 country40 target enrollmentMay 7, 2024

ConditionsPostoperative Pain, Acute

Interventionstransversus abdominis plane block transversalis fascial plane block

Overview

Phase: Not Applicable
Intervention: transversus abdominis plane block
Conditions: Postoperative Pain, Acute
Sponsor: Seoul National University Hospital
Enrollment: 40
Locations: 1
Primary Endpoint: total consumption of opioid (mcg/kg)
Status: Completed
Last Updated: 18 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 7, 2024

End Date

December 31, 2025

Last Updated

18 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

Professor

Seoul National University Hospital

Eligibility Criteria

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

Arms & Interventions

transversus abdominis plane block

Intervention: transversus abdominis plane block

transversalis fascial plane block

Intervention: transversalis fascial plane block

Outcomes

Primary Outcomes

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

The incidence of side effects of analgesic medications (percent)(within 24 hours after the end of surgery)
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)
Procedure time (min)(within 10 minutes after the end of surgery)
Cold sensation(at 30 minutes after the end of surgery)
First ambulation (hours)(within 24 hours after the end of surgery)
Sleep quality score(at 24 hours after the end of surgery)
Satisfaction score(at 24 hours after the end of surgery)