Orthopedic Disorder
Conditions
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.
Interventions
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
PROCEDUREControl
No regional block is provided at the end of surgery.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| total opioid consumption at 12 hours after the end of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Wong-Baker Faces Pain Rating Scale | at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery. | 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 | 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery. | 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 | at 12hours, and 24hours after the end of surgery. | Total additional dose of nalbuphine (mg) per kilogram of body weight. |
| Total additional dose of ketorolac | at 12hours, and 24hours after the end of surgery. | Total additional dose of ketorolac (mg) per kilogram of body weight. |
| The incidence of side effects of analgesic medications | within 24 hours after the end of surgery | Nausea, Vomit, Constipation, Pruritus, Dizziness, Dry mouth, Sedation |
| The incidence of side effects of ropivacaine | within 1 hour after the end of surgery | Arrhythmia, Hypotension, ST change, Dizziness, Convulsion |
| total opioid consumption at 24 hours after the end of surgery | 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. |
| Neurological Pupil indexTM (NPi) | at 1 hour after the end of surgery | measured by pupillometer |
| pupil constriction velocity (CV) | at 1 hour after the end of surgery | measured by pupillometer |
| 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) | 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) | 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) | At the second postoperative day (POD-2) | Normal capillary refill time (\< 3 seconds) at the second postoperative day (POD-2) |
| Hospital stay | within 14 days after the end of surgery | Hospital stay (days) |
Countries
South Korea
Contacts
Primary ContactYoung Eun Jang, MD
Backup ContactJin-Tae Kim, MD,PhD
Outcome results
None listed