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临床试验/NCT04669145
NCT04669145已完成2 期

Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial

Ochsner Health System1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年6月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Opioid Consumption

研究概览

简要总结

To identify the benefits from regional anesthesia use as pain management in the pediatric population by delineating the differences in efficacy of continuous nerve blockade versus single-shot techniques after pediatric orthopaedic limb procedures. By doing this, the investigators can determine if specific anesthetic techniques should become a standard of care in pain management for the pediatric population and supersede the need for opioid medication.

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
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing primary orthopaedic limb surgery
  • Outpatient orthopaedic surgeries
  • Patients undergoing orthopaedic surgery who would normally receive regional anesthesia

排除标准

  • Patients younger than 5 years of ago or older than 18 years of age
  • Revision orthopaedic surgeries
  • Spinal orthopaedic surgeries
  • Orthopaedic surgeries where the standard of care for type of regional anesthesia has been established (continuous regional for ACL reconstruction)
  • Patients with the inability to articulate pain scores
  • Inpatient orthopaedic surgeries
  • Patients undergoing orthopaedic limb surgery with risk of compartment syndrome (i.e. acute supracondylar humerus fractures)

研究组 & 干预措施

Continuous Regional Anesthesia Lower Limb Surgery

Experimental

Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks A catheter will be placed for the given block for 48 hours. Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

干预措施: Ropivacaine (Drug)

Single Shot Regional Anesthesia Lower Limb Surgery

Experimental

Various types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks. These blocks will be given via a single dose or "single shot". Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

干预措施: Ropivacaine (Drug)

Continuous Regional Anesthesia Upper Limb Surgery

Experimental

Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

干预措施: Ropivacaine (Drug)

Single Shot Regional Anesthesia Upper Limb Surgery

Experimental

Various types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Opioid Consumption

时间窗: For first 48 hours post-operatively.

Amount of opioid medications taken for pain control.

次要结局

  • Emergency Room Visits(Within 2 weeks post-operatively.)
  • Opioid Consumption(Through 168 hours post-operatively.)
  • Pain Scores(At 2 weeks post-operatively.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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