NCT00423241终止不适用
A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 6
- 主要终点
- Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
研究概览
简要总结
This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures.
*Trademark
详细描述
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
- •Subject is 18 years or older
- •Subject must be willing to participate in the study, and provide informed consent to participate.
排除标准
- •Subjects undergoing recurrent hernia repair;
- •Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
- •Subjects with known allergy to bupivacaine;
- •Subjects with immunodeficiency diseases (including known HIV);
- •Subjects with any findings identified by the surgeon that may preclude conduct of the study;
- •Subjects who are known current alcohol and/or drug abusers;
研究组 & 干预措施
SEMPERFLO Pain Management System
Experimental
干预措施: SEMPERFLO Pain Management System (Device)
ON-Q PainBuster Post-Op Pain Relief System
Active Comparator
干预措施: ON-Q PainBuster Post-Op Pain Relief System (Device)
结局指标
主要结局
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
时间窗: twenty-four hours post procedure
次要结局
- Numeric pain scale scores at rest and with coughing(24, 48, 72, 96, and 120 hours post-procedure)
- Narcotic and non-narcotic analgesic usage(24, 48, 72, 96 and 120 hours post- procedure)
研究者
研究点 (6)
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