Pain control methods for children undergoing bone grafting
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
This study is testing which of two pain control methods works better for kids aged 7 to 18 after they have surgery to take bone from their hip for dental work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06403462 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two pain control methods in children aged 7 to 18 undergoing iliac bone grafting for alveoloplasty under general anesthesia. The methods being evaluated are the ultrasound-guided transversus abdominis plane block and the transversalis fascia plane block. By assessing postoperative pain levels, the study seeks to identify which technique provides better pain relief for pediatric patients. The trial will involve monitoring pain responses and recovery outcomes following the surgical procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7 to 18 who are scheduled for iliac bone grafting for alveoloplasty.
Not a fit: Patients with conditions affecting pain sensitivity or those unable to communicate their pain effectively may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for children undergoing bone grafting procedures.
How similar studies have performed: Previous studies have shown promising results with similar regional anesthesia techniques in managing postoperative pain in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Children's Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jin-Tae Kim, M.D.,Ph.D.
- Email: jb4001@snu.ac.kr
- Phone: 0220723664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.