Ultrasound-guided FICB for Proximal Femoral Osteotomy in Pediatric Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FICB 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
Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
|
| Placebo Comparator: Control No regional block is provided at the end of surgery. |
Procedure: Control
No regional block is provided at the end of surgery.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- Hospital stay [within 14 days after the end of surgery]
Hospital stay (days)
- 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)
Eligibility Criteria
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)
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Allergy to opioid
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Allergy to local anesthetics
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Disease in heart, lung, kidney, and liver
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Coagulation disorder
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Disease in the central and peripheral nervous system
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Unstable vital sign
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Significant renal impairment (Creatinine> 3.0 mg/dl)
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Significant hepatic impairment (aspartate transaminase> 120 unit/L, alanine aminotransferase> 120 unit/L)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jin-Tae Kim | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Seoul National University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-2008-003-1145