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临床试验/NCT02892513
NCT02892513已完成不适用

Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Total Narcotic Consumption During Hospital Stay

研究概览

简要总结

Pain after surgery is unavoidable, and opioid medications are the cornerstone of most pain management regimens. However, they come at a cost with profound impacts on gastrointestinal motility, respiratory depression, and even long-term dependence. Stimulating the external ear with cutaneous electrical current is similar to acupuncture and could help improve postoperative pain. The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]), has been used with success in treating opioid withdrawal and in animal studies has shown increases in pain thresholds. The investigators propose a prospective, randomized, placebo-controlled, double-blinded trial to evaluate if auricular neurostimulation improves postoperative pain and reduces opioid requirements for patients undergoing elective colon surgery.

pain perception in post-operative patients may be modulated via the auricular branch of the vagus nerve. This has the potential to reduce the use of opioid medications, which will in turn reduce the incidence of postoperative ileus and reduce patient need for and dependence on narcotic pain medications. This would have an enormous economic impact due to decreased length of hospital stays for patients who undergo abdominal surgery. In addition, opioid reduction could potentially lessen the national crisis of opioid addiction.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • elective colon surgery
  • age over 18 years
  • provide informed consent

排除标准

  • emergency surgery
  • history of opioid dependence/use, anxiety with anxiolytic use
  • planned ICU admission postoperatively
  • adhesive allergy/sensitivity
  • other medical contraindications

研究组 & 干预措施

Active Stimulation

Experimental

Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.

干预措施: Percutaneous auricular neurostimulation (Device)

Sham Percutaneous Neurostimulation

Sham Comparator

Participants will have inactive device worn for 5 days during and after elective surgery.

干预措施: Sham percutaneous auricular neurostimulation (Device)

结局指标

主要结局

Total Narcotic Consumption During Hospital Stay

时间窗: 5 days

Total inpatient narcotic use measured in oral morphine equivalents per day (OME)

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

Carrie Peterson

Assistant Professor

Medical College of Wisconsin

研究点 (2)

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