Prospective, Randomized, Controlled Comparison of Local Anesthetic Infusion Pump Versus DepoFoam Bupivacaine For Pain Management After Unilateral Deep Inferior Epigastic Perforator Free Flap Reconstruction
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
- 否
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
Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.
干预措施: Depobupivacaine (Drug)
OnQ Pump
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
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
Risal Djohan
Principal Investigator
The Cleveland Clinic
