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Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

Primary Purpose

Orthopedic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound-guided fascia iliaca compartment block
Control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthopedic Disorder

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Jin-Tae KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

FICB

Control

Arm Description

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

No regional block is provided at the end of surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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".
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.
Total additional dose of nalbuphine
Total additional dose of nalbuphine (mg) per kilogram of body weight.
Total additional dose of ketorolac
Total additional dose of ketorolac (mg) per kilogram of body weight.
The incidence of side effects of analgesic medications
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation
The incidence of side effects of ropivacaine
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Hospital stay
Hospital stay (days)
Neurological Pupil indexTM (NPi)
measured by pupillometer
pupil constriction velocity (CV)
measured by pupillometer
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)
Intact toe sensory at the second postoperative day (POD-2)
Intact toe sensory 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)

Full Information

First Posted
September 24, 2020
Last Updated
June 2, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04570891
Brief Title
Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients
Official Title
Ultrasound-guided Fascia Iliaca Compartment Block for Proximal Femoral Osteotomy in Pediatric Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FICB
Arm Type
Experimental
Arm Description
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No regional block is provided at the end of surgery.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided fascia iliaca compartment block
Intervention Description
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
No regional block is provided at the end of surgery.
Primary Outcome Measure Information:
Title
total opioid consumption at 12 hours after the end of surgery
Description
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.
Time Frame
at 12 hours after the end of surgery
Secondary Outcome Measure Information:
Title
total opioid consumption at 24 hours after the end of surgery
Description
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.
Time Frame
at 24 hours after the end of surgery
Title
Wong-Baker Faces Pain Rating Scale
Description
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".
Time Frame
at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Title
Numeric rating scale
Description
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.
Time Frame
10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
Title
Total additional dose of nalbuphine
Description
Total additional dose of nalbuphine (mg) per kilogram of body weight.
Time Frame
at 12hours, and 24hours after the end of surgery.
Title
Total additional dose of ketorolac
Description
Total additional dose of ketorolac (mg) per kilogram of body weight.
Time Frame
at 12hours, and 24hours after the end of surgery.
Title
The incidence of side effects of analgesic medications
Description
Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation
Time Frame
within 24 hours after the end of surgery
Title
The incidence of side effects of ropivacaine
Description
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Time Frame
within 1 hour after the end of surgery
Title
Hospital stay
Description
Hospital stay (days)
Time Frame
within 14 days after the end of surgery
Title
Neurological Pupil indexTM (NPi)
Description
measured by pupillometer
Time Frame
at 1 hour after the end of surgery
Title
pupil constriction velocity (CV)
Description
measured by pupillometer
Time Frame
at 1 hour after the end of surgery
Title
Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
Description
Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
Time Frame
At the second postoperative day (POD-2)
Title
Intact toe sensory at the second postoperative day (POD-2)
Description
Intact toe sensory at the second postoperative day (POD-2)
Time Frame
At the second postoperative day (POD-2)
Title
Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
Description
Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
Time Frame
At the second postoperative day (POD-2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Eun Jang, MD
Phone
082-02-2072-3665
Email
na0ag2@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim, MD,PhD
Phone
082-02-2072-3665
Email
jintae73@gmail.com
Facility Information:
Facility Name
Jin-Tae Kim
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, MD. PhD
Phone
82-2-2072-3295
Email
kimjintae73@dreamwiz.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients

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