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临床试验/NCT02542956
NCT02542956撤回4 期

Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Abdominoplasty and TRAM Flap Breast Reconstruction.

Henry Ford Health System1 个研究点 分布在 1 个国家开始时间: 2014年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Recurrence of Pain

研究概览

简要总结

The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

详细描述

The purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (TRAM) flap for breast reconstruction. The investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (DepoFoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. These drugs and devices are approved by the FDA (Food and Drug Administration) for the purpose of pain control after surgery, and have been used for this purpose before.

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

入选标准

  • Undergoing abdominoplasty or TRAM flap breast reconstruction

排除标准

  • A medical condition that could interfere with study participation
  • Body weight less than 50 kg
  • Participating in another study involving an investigational medication

研究组 & 干预措施

Exparel

Active Comparator

Injection of Exparel

干预措施: Exparel (Drug)

Marcaine

Active Comparator

Receive Marcaine in a pain pump or by injection

干预措施: Marcaine (Drug)

结局指标

主要结局

Recurrence of Pain

时间窗: 30 minute to 72 hours after surgery

次要结局

未报告次要终点

研究者

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

Donna Tepper M.D

Plastic Surgeon

Henry Ford Health System

研究点 (1)

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