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临床试验/NCT03906838
NCT03906838撤回早期 1 期

Does Regional Anesthesia Reduce Postoperative Opioid Consumption in Subjects Undergoing Fibula Free Flap Reconstruction of the Head and Neck: A Prospective Trial

University of Florida1 个研究点 分布在 1 个国家开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
撤回
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Despite many recent advances in pain management, post-operative pain is widely considered to be poorly managed. Furthermore, the mainstay of current pain management is opioids, for which there is strong evidence of ill effects and long-term potential for addiction. There are many studies demonstrating that perineural regional anesthesia can be superior to intravenous opioid analgesia, and that the technique is safe. By using temporary implanted catheters, this method can now deliver prolonged analgesia, thus reducing the need for opioids in the postoperative period. Regional anesthesia is a proven technique and used daily by anesthesiologists, and it is also the first choice for hip and knee replacement surgery for orthopedic surgeons. Patients undergoing head and neck reconstruction with the use of free tissue transfer experience a significant amount of post-operative pain due to the complexity of the surgery, the presence of a head and neck surgical site as well as a secondary donor site, and existing co-morbidities, most commonly malignancy, that also cause significant pain. These patients often require opioids for pain control throughout the hospital stay, and are almost always discharged home with additional opioids. By utilizing regional anesthesia blocks at the donor sites, the investigators can potentially reduce post-operative pain while also reducing the use of opioids.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
  • Subjects undergoing primary or secondary reconstruction

排除标准

  • Subjects needing elevation of care to the intensive care unit due to remaining intubated for extended period of time or other complications during the peri or post operative period
  • Subjects with surgical complications requiring significant alteration of the treatment plan
  • o Subjects requiring a return to the operating room during admission will be excluded, unless it is for a procedure not related to the original surgery occurring after post op day 3, such as a gastrostomy tube or long term IV access.
  • Subjects with true allergies to the study drugs
  • Subjects undergoing reconstruction with more than 1 free flap, or with the use of any additional regional flaps
  • History of substance dependence or enrollment in a pain management program
  • Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin.
  • Subjects who do not stay in the hospital for at least 4 days post operatively
  • Subjects requiring anticoagulation will not require modifications prior to receiving regional anesthesia.
  • Inability to properly place catheter or administer the regional anesthesia

研究组 & 干预措施

Regional Nerve Block

Experimental

Subjects in the regional anesthesia cohort will have a regional anesthesia block and/or catheter placement administered according to current hospital policies and our established standard of care.

干预措施: Ropivacaine injection (Drug)

结局指标

主要结局

Opioid consumption

时间窗: 72 hours (3 days) post-operatively

Defined by the research team as the subjects' morphine equivalent dose at 72 hours (3 days) post-operatively. The postoperative period commences at extubation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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