Postoperative Pain, Acute
Conditions
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
Interventions
PROCEDUREtransversalis fascial plane block
ultrasound guidance transversalis fascial plane block after iliac bone graft
PROCEDUREtransversus abdominis plane block
ultrasound guidance lateral transversus abdominis plane block after iliac bone graft
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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 |
| 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). |
| Procedure time (min) | within 10 minutes after the end of surgery | total procedure time from needle puncture to the end of block |
| First ambulation (hours) | within 24 hours after the end of surgery | Time to first ambulation (hours) |
| 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). |
Countries
South Korea
Outcome results
None listed