Transversalis Fascia Plane Block for Iliac Bone Graft in Children
- Conditions
- Postoperative Pain, Acute
- Interventions
- Procedure: transversus abdominis plane blockProcedure: transversalis fascial plane block
- Registration Number
- NCT06403462
- Lead Sponsor
- Seoul National University Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description transversus abdominis plane block transversus abdominis plane block - transversalis fascial plane block transversalis fascial plane block -
- Primary Outcome Measures
Name Time Method total consumption of opioid (mcg/kg) from the end of surgery up to 24 hours later total opioid consumption at 24 hours after the end of surgery
- Secondary Outcome Measures
Name Time Method The incidence of side effects of analgesic medications (percent) 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.
Postoperative Pain score 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
Total consumption of non-opioid (mg/kg) within 24 hours after the end of surgery Non-opioid analgesics usage per body weight within 24 hours after surgery
Satisfaction score at 24 hours after the end of surgery Patient satisfaction score (0-100 points, with 100 being very satisfied and 0 being very dissatisfied).
Procedure time (min) within 10 minutes after the end of surgery total procedure time from needle puncture to the end of block
Cold sensation 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).
Sleep quality score at 24 hours after the end of surgery Quality of sleep on the day of operation (satisfaction score, 0-100 points, with 100 being very satisfied and 0 being very dissatisfied).
First ambulation (hours) within 24 hours after the end of surgery Time to first ambulation (hours)
Trial Locations
- Locations (1)
Seoul National University Children's Hospital
🇰🇷Seoul, Korea, Republic of