Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Procedure: Ultrasound-guided fascia iliaca compartment block; Procedure: Control

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Eun Jang, MD; Phone Number: 082-02-2072-3665; Email: na0ag2@hotmail.com
• Study Contact Backup: Name: Jin-Tae Kim, MD,PhD; Phone Number: 082-02-2072-3665; Email: jintae73@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Jin-Tae Kim
    • Contact: Jin-Tae Kim, MD. PhD; Phone Number: 82-2-2072-3295; Email: kimjintae73@dreamwiz.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: H-2008-003-1145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No