Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults
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
- 否
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
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
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
Carrie Peterson
Assistant Professor
Medical College of Wisconsin
