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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
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.
Jin-Tae Kim
Seoul, South Korea
RECRUITINGtotal 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.
Time frame: at 12 hours after the end of surgery
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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: within 24 hours after the end of surgery
The incidence of side effects of ropivacaine
Arrhythmia, Hypotension, ST change, Dizziness, Convulsion
Time frame: within 1 hour after the end of surgery
Hospital stay
Hospital stay (days)
Time frame: within 14 days after the end of surgery
Neurological Pupil indexTM (NPi)
measured by pupillometer
Time frame: at 1 hour after the end of surgery
pupil constriction velocity (CV)
measured by pupillometer
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At the second postoperative day (POD-2)
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