Ultrasound-guided Fascia Iliaca Compartment Block for Proximal Femoral Osteotomy in Pediatric Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- total opioid consumption at 12 hours after the end of surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •36 children aged between 3 and 18 years who undergo proximal femoral osteotomy
排除标准
- •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)
结局指标
主要结局
total opioid consumption at 12 hours after the end of surgery
时间窗: 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.
次要结局
- total opioid consumption at 24 hours after the end of surgery(at 24 hours 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 ketorolac(at 12hours, and 24hours after the end of surgery.)
- pupil constriction velocity (CV)(at 1 hour after the end of surgery)
- Total additional dose of nalbuphine(at 12hours, and 24hours after the end of surgery.)
- The incidence of side effects of ropivacaine(within 1 hour after the end of surgery)
- Hospital stay(within 14 days after the end of surgery)
- Neurological Pupil indexTM (NPi)(at 1 hour after the end of surgery)
- Intact toe sensory at the second postoperative day (POD-2)(At the second postoperative day (POD-2))
- Wong-Baker Faces Pain Rating Scale(at 10 minutes after the PACU admin, 1hour, 6hours, and 24hours after the end of surgery.)
- The incidence of side effects of analgesic medications(within 24 hours after the end of surgery)
- Normal capillary refill time (< 3 seconds) 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)(At the second postoperative day (POD-2))
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital