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临床试验/NCT01500655
NCT01500655已完成不适用

Evaluation of Ultrasound-Guided Block of the Lateral Femoral Cutaneous Nerve in Pediatric Patients for Reconstructive Surgical Procedures

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Visual Analog Pain Scale

研究概览

简要总结

The purpose of this study is to determine whether either a peripheral nerve block under ultrasound (u/s) guidance of the lateral femoral cutaneous nerve (LFCN), versus an u/s guided block of the nerve followed by continuous catheter infusion of local anesthetic, offers better post-operative analgesia in pediatric burn patients undergoing reconstructive surgery, than the current analgesic regimen of subcutaneous local anesthetic infiltration.

Eligible subject, pediatric patients having reconstructive surgery for burns, having skin graft donor sites of the lateral thighs, will be randomized into three groups: control (having local infiltration of site), ultrasound guided nerve block, or ultrasound guided nerve block with catheter placement --fascia iliac.

Post-operative comfort will be assessed over the next 48 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • going for reconstructive surgery requiring split thickness skin graft
  • patient's donor site will be in distribution of lateral femoral cutaneous nerve
  • age >=2 and <22
  • patient emotionally/intellectually able to describe intensity of post-op pain using VAS or Wong- Baker faces scale.

排除标准

  • potential block/catheter site infected or burned.
  • intolerance/allergy to local anesthetics
  • BMI > 30
  • American Society of Anesthesiologists (ASA) score > 2

结局指标

主要结局

Visual Analog Pain Scale

时间窗: Q4 hours,while awake, for 48 hours

We will assess a VAS of pain (0-10)--every 4 hours postoperatively while the patient is awake, for 48 hours post-op.

次要结局

  • Narcotic use(48 hours postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Erik S. Shank, MD

Staff Physician: Pediatric Anesthesiologist

Massachusetts General Hospital

研究点 (2)

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