NCT04570891

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 30, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

September 24, 2020

Last Update Submit

November 21, 2023

Conditions

Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • total opioid consumption at 24 hours after the end of surgery

    at 24 hours after the end of surgery

  • Wong-Baker Faces Pain Rating Scale

    at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.

  • Numeric rating scale

    10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.

  • Total additional dose of nalbuphine

    at 12hours, and 24hours after the end of surgery.

  • Total additional dose of ketorolac

    at 12hours, and 24hours after the end of surgery.

  • +8 more secondary outcomes

Study Arms (2)

FICB

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

No regional block is provided at the end of surgery.

Procedure: Control

Interventions

Ultrasound-guided fascia iliaca compartment blockPROCEDURE

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

FICB
ControlPROCEDURE

No regional block is provided at the end of surgery.

Control

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Young Eun Jang, MD

CONTACT

082-02-2072-3665na0ag2@hotmail.com

Jin-Tae Kim, MD,PhD

CONTACT

082-02-2072-3665jintae73@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 30, 2020

Study Start

December 15, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations

KR(1)