Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04570891
• Other study ID #: H-2008-003-1145
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Young Eun Jang, MD
• Phone: 082-02-2072-3665
• Email: na0ag2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

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.
• Control
No regional block is provided at the end of surgery.

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	The incidence of side effects of analgesic medications	Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation	within 24 hours after the end of surgery
Secondary	The incidence of side effects of ropivacaine	Arrhythmia, Hypotension, ST change, Dizziness, Convulsion	within 1 hour after the end of surgery
Secondary	Hospital stay	Hospital stay (days)	within 14 days after the end of surgery
Secondary	Neurological Pupil indexTM (NPi)	measured by pupillometer	at 1 hour after the end of surgery
Secondary	pupil constriction velocity (CV)	measured by pupillometer	at 1 hour after the end of surgery
Secondary	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)
Secondary	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)
Secondary	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)