Orthopedic DisorderNCT04570891
Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients
A study testing Ultrasound-guided fascia iliaca compartment block in people with Orthopedic Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on the postoperative pain and opioid consumption in pediatric patients (3y≤ age <18y) who will undergo orthopedics surgery (proximal femoral osteotomy). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Ultrasound-guided fascia iliaca compartment block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2020to 31 Dec 2024
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 36 children aged between 3 and 18 years who undergo proximal femoral osteotomy
Who cannot join
- Complex surgery (other than proximal femoral osteotomy)
- Allergy to opioid
- Allergy to local anesthetics
- Disease in heart, lung, kidney, and liver
- Coagulation disorder
- Disease in the central and peripheral nervous system
Show all 9Show fewer
- Unstable vital sign
- Significant renal impairment (Creatinine> 3.0 mg/dl)
- Significant hepatic impairment (aspartate transaminase> 120 unit/L, alanine aminotransferase> 120 unit/L)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jin-Tae Kim
Seoul
Jin-Tae Kim, MD. PhD, 82-2-2072-3295, kimjintae73@dreamwiz.com
About this study
Official title: Ultrasound-guided Fascia Iliaca Compartment Block for Proximal Femoral Osteotomy in Pediatric Patients: a Randomized Controlled Trial
This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on the postoperative pain and opioid consumption in pediatric patients (3y≤ age <18y) who will undergo orthopedics surgery (proximal femoral osteotomy).
Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.
The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.
Read the detailed description
This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on postoperative pain and opioid consumption in pediatric patients (3y≤ age <18y) who will undergo orthopedics surgery (proximal femoral osteotomy).
Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.
The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.
- Conditions
- Orthopedic Disorder
- Being tested
- Ultrasound-guided fascia iliaca compartment block, Control
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided fascia iliaca compartment blockProcedure or surgery
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
ControlProcedure or surgery
No regional block is provided at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| FICB | Experimental | Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery. Receives: Procedure: Ultrasound-guided fascia iliaca compartment block |
| Control | Placebo comparator | No regional block is provided at the end of surgery. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
total opioid consumption at 12 hours after the end of surgery
total opioid consumption at 12 hours after the end of surgery (IV Nalbuphine 1mg = IV Morphine 1mg = IV Fentanyl 10mcg (0.01mg) per kilogram of body weight.
Measured: at 12 hours after the end of surgery
Secondary outcomes (13)
total opioid consumption at 24 hours after the end of surgery
total opioid consumption at 24 hours after the end of surgery (IV Nalbuphine 1mg = IV Morphine 1mg = IV Fentanyl 10mcg (0.01mg) per kilogram of body weight.
Measured: at 24 hours after the end of surgery
Wong-Baker Faces Pain Rating Scale
by Wong-Baker Faces Pain Rating Scale: There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst".
Measured: at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Numeric rating scale
by Numeric rating scale: A numerical rating scale (NRS) 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: 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Total additional dose of nalbuphine
Total additional dose of nalbuphine (mg) per kilogram of body weight.
Measured: at 12hours, and 24hours after the end of surgery.
Total additional dose of ketorolac
Total additional dose of ketorolac (mg) per kilogram of body weight.
Measured: at 12hours, and 24hours after the end of surgery.
The incidence of side effects of analgesic medications
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation
Measured: within 24 hours after the end of surgery
The incidence of side effects of ropivacaine
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Measured: within 1 hour after the end of surgery
Hospital stay
Hospital stay (days)
Measured: within 14 days after the end of surgery
Neurological Pupil indexTM (NPi)
measured by pupillometer
Measured: at 1 hour after the end of surgery
pupil constriction velocity (CV)
measured by pupillometer
Measured: at 1 hour after the end of surgery
Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
Measured: At the second postoperative day (POD-2)
Intact toe sensory at the second postoperative day (POD-2)
Intact toe sensory at the second postoperative day (POD-2)
Measured: At the second postoperative day (POD-2)
Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
Measured: At the second postoperative day (POD-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start15 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
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
- NCT04570891
- Sponsor's protocol ID
- H-2008-003-1145
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Fascia Iliaca Compartment Block for Proximal Femoral Osteotomy in Pediatric Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04570891
- Acronym / sponsor ID
- H-2008-003-1145
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Sep 2020 (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.
This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on the postoperative pain and opioid consumption in pediatric patients (3y≤ age <18y) who will undergo orthopedics surgery (proximal femoral osteotomy).
Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.
The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.
Detailed description
This prospective randomized controlled trial aims to examine the effect of fascia iliaca compartment block on postoperative pain and opioid consumption in pediatric patients (3y≤ age <18y) who will undergo orthopedics surgery (proximal femoral osteotomy).
Patients will be allocated to either the FICB(Fascia iliaca compartment block + IV PCA) group or the control group (no block + IV PCA). Fascia iliaca compartment block will be performed using 0.25% ropivacaine (1mL/kg, MAX 30mL) under ultrasound-guidance at the end of surgery.
The total opioid consumption at 12, and 24 hours after the surgery, and the pain score at 10 min after PACU admin, 1,6,24 hours after the surgery, the total dose of additional rescue analgesia (intravenous ketorolac or nalbuphine) at 12 and 24 hours after the surgery will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FICB | Experimental | Procedure: Ultrasound-guided fascia iliaca compartment blockUltrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery. |
| Control | Placebo comparator | Procedure: ControlNo regional block is provided at the end of surgery. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 36 children aged between 3 and 18 years who undergo proximal femoral osteotomy
Key exclusion criteria (9 listed)
- Complex surgery (other than proximal femoral osteotomy)
- Allergy to opioid
- Allergy to local anesthetics
- Disease in heart, lung, kidney, and liver
- Coagulation disorder
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 |
|---|---|---|
| Ultrasound-guided fascia iliaca compartment blockUltrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery. | Procedure or surgery | FICB |
| ControlNo regional block is provided at the end of surgery. | Procedure or surgery | Control |
Primary outcome
total opioid consumption at 12 hours after the end of surgery
Time frame: at 12 hours after the end of surgery
total opioid consumption at 12 hours after the end of surgery (IV Nalbuphine 1mg = IV Morphine 1mg = IV Fentanyl 10mcg (0.01mg) per kilogram of body weight.
13 secondary outcomes
total opioid consumption at 24 hours after the end of surgery
Time frame: at 24 hours after the end of surgery
Wong-Baker Faces Pain Rating Scale
Time frame: at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Numeric rating scale
Time frame: 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Total additional dose of nalbuphine
Time frame: at 12hours, and 24hours after the end of surgery.
Total additional dose of ketorolac
Time frame: at 12hours, and 24hours after the end of surgery.
The incidence of side effects of analgesic medications
Time frame: within 24 hours after the end of surgery
The incidence of side effects of ropivacaine
Time frame: within 1 hour after the end of surgery
Hospital stay
Time frame: within 14 days after the end of surgery
Neurological Pupil indexTM (NPi)
Time frame: at 1 hour after the end of surgery
pupil constriction velocity (CV)
Time frame: at 1 hour after the end of surgery
Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
Time frame: At the second postoperative day (POD-2)
Intact toe sensory at the second postoperative day (POD-2)
Time frame: At the second postoperative day (POD-2)
Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
Time frame: At the second postoperative day (POD-2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided fascia iliaca compartment block in people with Orthopedic Disorder, 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Eun Jang, MD (082-02-2072-3665, na0ag2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total opioid consumption at 12 hours after the end of surgery (time frame: at 12 hours after the end of surgery). 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 22 Nov 2023.