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临床试验/NCT00616577
NCT00616577终止不适用

Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study

Loma Linda University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1
主要终点
Usage of Pain Medications

研究概览

简要总结

Caudal epidural analgesia (caudal block) is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Age 2 years or younger.
  • Weight 33 kg or less.
  • Scheduled for elective inguinal herniorrhaphy or orchiopexy.
  • American Society of Anesthesiologists Class 1, 2 or 3.

排除标准

  • Age over 2 years.
  • Weight over 33 kg.
  • Allergy to ropivacaine.
  • Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)

研究组 & 干预措施

Group CB

Experimental

Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.

干预措施: Ropivacaine (Drug)

Group CA

Active Comparator

Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.

干预措施: Ropivacaine (Drug)

Group LIA

Active Comparator

Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Usage of Pain Medications

时间窗: Over 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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