Clinical trial NCT06403462: Transversalis Fascia Plane Block for Iliac Bone Graft in Children
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: total consumption of opioid (mcg/kg)
timeFrame: from the end of surgery up to 24 hours later
Secondary outcomes:
measure: Postoperative Pain score
timeFrame: at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery
measure: Total consumption of non-opioid (mg/kg)
timeFrame: within 24 hours after the end of surgery
measure: Cold sensation
timeFrame: at 30 minutes after the end of surgery
measure: The incidence of side effects of analgesic medications (percent)
timeFrame: within 24 hours after the end of surgery
measure: Satisfaction score
timeFrame: at 24 hours after the end of surgery
measure: Sleep quality score
timeFrame: at 24 hours after the end of surgery
measure: Procedure time (min)
timeFrame: within 10 minutes after the end of surgery
measure: First ambulation (hours)
timeFrame: within 24 hours after the end of surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
References: