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临床试验/NCT04080739
NCT04080739已完成4 期

Regional Block for Postoperative Free Flap Care

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月13日最近更新:
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
100
试验地点
1
主要终点
Opioid Utilization Measured in Oral Morphine Equivalent (OME)

研究概览

简要总结

The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and neck patients undergoing microvascular free flap reconstruction.

详细描述

The increasing rate of opioid related overdose mortality is well documented in the literature and approached 15 per 100,000 in 2017. Because of a growing epidemic in the US, the medical community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life.

Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia decreases systemic adverse events including respiratory failure in abdominal surgery, decreases length of stay and improves rehabilitation in common orthopedic procedures such as total knee arthroplasty and shoulder arthroplasty. Second, the physiologic benefits of regional anesthesia are compelling including augmented micro and macrocirculation, maintenance of body temperature and decreased systemic stress response through chemical sympathectomy. Finally, regional anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric, and adult patients.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Experimental Group

Experimental

US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.

干预措施: ropivicaine 0.2% (Drug)

结局指标

主要结局

Opioid Utilization Measured in Oral Morphine Equivalent (OME)

时间窗: 21 days

Opioid Utilization was measured by the number of mg of Oral Morphine Equivalent (oral pain medication) was given to patients.

次要结局

  • Opioid Medication Use(21 days)

研究者

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

Anthony Morlandt

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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