Clinical trial NCT04570891: 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
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 36
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: total opioid consumption at 12 hours after the end of surgery
timeFrame: at 12 hours after the end of surgery
Secondary outcomes:
measure: total opioid consumption at 24 hours after the end of surgery
timeFrame: at 24 hours after the end of surgery
measure: Wong-Baker Faces Pain Rating Scale
timeFrame: at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
measure: Numeric rating scale
timeFrame: 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.
measure: Total additional dose of nalbuphine
timeFrame: at 12hours, and 24hours after the end of surgery.
measure: Total additional dose of ketorolac
timeFrame: at 12hours, and 24hours after the end of surgery.
measure: The incidence of side effects of analgesic medications
timeFrame: within 24 hours after the end of surgery
measure: The incidence of side effects of ropivacaine
timeFrame: within 1 hour after the end of surgery
measure: Hospital stay
timeFrame: within 14 days after the end of surgery
measure: Neurological Pupil indexTM (NPi)
timeFrame: at 1 hour after the end of surgery
measure: pupil constriction velocity (CV)
timeFrame: at 1 hour after the end of surgery
measure: Extensor hallucis longus function (motor power of extension of the big toe: I-V) at the second postoperative day (POD-2)
timeFrame: At the second postoperative day (POD-2)
measure: Intact toe sensory at the second postoperative day (POD-2)
timeFrame: At the second postoperative day (POD-2)
measure: Normal capillary refill time (< 3 seconds) at the second postoperative day (POD-2)
timeFrame: At the second postoperative day (POD-2)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References: