Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bang Blinding Index (BI)
研究概览
简要总结
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.
详细描述
According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing ACL Surgery with a participating surgeon
- •English Speaking
- •Patients at least 12 years old
- •Planned spinal anesthesia without peripheral nerve block (rescue block is okay)
排除标准
- •Patients under the age of 12
- •Non-English speaking patients
- •Patients planning on having general anesthesia
- •Planned preop peripheral nerve block
- •Patients with the inability to understand/follow study protocol
- •Patients with pacemaker/AICD
- •Non-native Ear/Previous scarring/surgical manipulation of ear
- •Patients with contraindications to intra-op protocol
- •Chronic pain patients
- •Patients who have regularly used opioids for more than 6 weeks prior to surgery
- •Patients with guages in their ears
- •Patients who refuse to remove earrings/piercings prior to surgery
- •Patients with nickel allergies (needles are made of nickel)
结局指标
主要结局
Bang Blinding Index (BI)
时间窗: postoperative day 1
Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.
次要结局
- Numeric Rating Scale (NRS) Pain With Movement Scores(postoperative day 1)
- Numeric Rating Scale (NRS) Pain at Rest Scores(postoperative day 1)
- Opioid Consumption(day of surgery through postoperative day 1)