跳至主要内容
临床试验/NCT04284930
NCT04284930已完成4 期

Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年2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
已完成
入组人数
21
试验地点
1
主要终点
Total Narcotic Usage

研究概览

简要总结

Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.

详细描述

Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Non pregnant women
  • age 18 years or older
  • scheduled to have unilateral DIEP flap breast reconstruction.
  • Must have ASA physical status classification of 1,2, or 3

排除标准

  • concurrent or recent medical condition that could interfere with study participation
  • history of any of the following:
  • hepatitis
  • alcohol/substance abuse
  • uncontrolled psychiatric disorders
  • known allergy/ contraindication to any of the following:
  • amide-type local anesthetics
  • Body weight of less than 50 kg
  • have participated in another study involving an investigational medication with in the past 30 days
  • taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery

研究组 & 干预措施

Depobupivacaine

Experimental

Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.

干预措施: Depobupivacaine (Drug)

OnQ Pump

Active Comparator

Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.

干预措施: OnQ pump (Drug)

bupivacaine

Active Comparator

Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.

干预措施: 0.25% Bupivacaine (Drug)

结局指标

主要结局

Total Narcotic Usage

时间窗: total hospital stay, an average of 3 days

Post-op pain measured by total post-op Morphine equivalents

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

Risal Djohan

Principal Investigator

The Cleveland Clinic

研究点 (1)

Loading locations...

相似试验

Comparison of Local Anesthetic Infusion Pump Versus... | 临床试验