Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

Seoul National University

Status: Enrolling

Conditions: Orthopedic Disorder

Treatments: Procedure: Control; Procedure: Ultrasound-guided fascia iliaca compartment block

Study type: Interventional

Funder types: Other

Identifiers

NCT04570891

H-2008-003-1145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 36 children aged between 3 and 18 years who undergo proximal femoral osteotomy

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

FICB

Experimental group

Description:

Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.

Treatment:

Procedure: Ultrasound-guided fascia iliaca compartment block

Control

Placebo Comparator group

Description:

No regional block is provided at the end of surgery.

Treatment:

Procedure: Control