Postoperative Pain, AcuteNCT06403462
Transversalis Fascia Plane Block for Iliac Bone Graft in Children
A study testing transversalis fascial plane block and transversus abdominis plane block in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- transversalis fascial plane block and transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, 110-744
About this study
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
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
- Conditions
- Postoperative Pain, Acute
- Being tested
- transversalis fascial plane block, transversus abdominis plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversalis fascial plane blockProcedure or surgery
ultrasound guidance transversalis fascial plane block after iliac bone graft
transversus abdominis plane blockProcedure or surgery
ultrasound guidance posterior transversus abdominis plane block after iliac bone graft
| Study group | Role | What they receive |
|---|---|---|
| transversus abdominis plane block | Active comparator | Not described Receives: Procedure: transversus abdominis plane block |
| transversalis fascial plane block | Experimental | Not described Receives: Procedure: transversalis fascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
total consumption of opioid (mcg/kg)
total opioid consumption at 24 hours after the end of surgery
Measured: from the end of surgery up to 24 hours later
Secondary outcomes (6)
Postoperative Pain score
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
Measured: at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery
Total consumption of non-opioid (mg/kg)
Non-opioid analgesics usage per body weight within 24 hours after surgery
Measured: within 24 hours after the end of surgery
Cold sensation
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).
Measured: at 30 minutes after the end of surgery
The incidence of side effects of analgesic medications (percent)
Analgesic-related side effects (nausea, vomiting, constipation, pruritis, dizziness, dry mouth, somnolence, etc.) within 24 hours after surgery.
Measured: within 24 hours after the end of surgery
Satisfaction score
Patient satisfaction score (0-10 points, with 10 being very satisfied and 0 being very dissatisfied).
Measured: at 24 hours after the end of surgery
Sleep quality score
Quality of sleep on the day of operation (satisfaction score, 0-10 points, with 10 being very satisfied and 0 being very dissatisfied).
Measured: at 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start7 May 2024
- Primary completion30 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403462
- Sponsor's protocol ID
- H-2311-167-1488
- Status last verified
- Apr 2026
- First submitted
- 3 May 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06403462
- Acronym / sponsor ID
- H-2311-167-1488
- Conditions
- Postoperative Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transversus abdominis plane block | Active comparator | Procedure: transversus abdominis plane block |
| transversalis fascial plane block | Experimental | Procedure: transversalis fascial plane block |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transversalis fascial plane blockultrasound guidance transversalis fascial plane block after iliac bone graft | Procedure or surgery | transversalis fascial plane block |
| transversus abdominis plane blockultrasound guidance posterior transversus abdominis plane block after iliac bone graft | Procedure or surgery | transversus abdominis plane block |
Primary outcome
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
6 secondary outcomes
Postoperative Pain score
Time frame: at 30 minutes, 1 hour, 3 hours, 6 hours, 24 hours after the end of surgery
Total consumption of non-opioid (mg/kg)
Time frame: within 24 hours after the end of surgery
Cold sensation
Time frame: at 30 minutes after the end of surgery
The incidence of side effects of analgesic medications (percent)
Time frame: within 24 hours after the end of surgery
Satisfaction score
Time frame: at 24 hours after the end of surgery
Sleep quality score
Time frame: at 24 hours after the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversalis fascial plane block and transversus abdominis plane block in people with Postoperative Pain, Acute, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total consumption of opioid (mcg/kg) (time frame: from the end of surgery up to 24 hours later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.