Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients
NCT ID: NCT04570891
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2020-12-15
2024-12-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FICB
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
Ultrasound-guided fascia iliaca compartment block
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
Control
No regional block is provided at the end of surgery.
Control
No regional block is provided at the end of surgery.
Interventions
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Ultrasound-guided fascia iliaca compartment block
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
Control
No regional block is provided at the end of surgery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergy to opioid
* Allergy to local anesthetics
* Disease in heart, lung, kidney, and liver
* Coagulation disorder
* Disease in the central and peripheral nervous system
* Unstable vital sign
* Significant renal impairment (Creatinine\> 3.0 mg/dl)
* Significant hepatic impairment (aspartate transaminase\> 120 unit/L, alanine aminotransferase\> 120 unit/L)
3 Years
18 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Jin-Tae Kim
Professor
Locations
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Jin-Tae Kim
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-2008-003-1145
Identifier Type: -
Identifier Source: org_study_id