Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ultrasound-guided Fascia Iliaca Compartment Block for Proximal Femoral Osteotomy in Pediatric Patients: a Randomized Controlled Trial

Conditions
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Orthopedic Disorder

Intervention / Treatment
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* Procedure: Ultrasound-guided fascia iliaca compartment block
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FICB<br>Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery. | Procedure: Ultrasound-guided fascia iliaca compartment block<br>* Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.<br>|
| Placebo Comparator: Control<br>No regional block is provided at the end of surgery. | Procedure: Control<br>* No regional block is provided at the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at 12 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | within 24 hours after the end of surgery | 
| The incidence of side effects of ropivacaine | Arrhythmia, Hypotension, ST change, Dizziness, Convulsion | within 1 hour after the end of surgery | 
| Hospital stay | Hospital stay (days) | within 14 days after the end of surgery | 
| Neurological Pupil indexTM (NPi) | measured by pupillometer | at 1 hour after the end of surgery | 
| pupil constriction velocity (CV) | measured by pupillometer | 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) | 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) | 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) | At the second postoperative day (POD-2) |