A Single-blind Randomized Placebo Controlled Trial of Lidocaine Patches for Opioid Reduction in Geriatric Rib Fracture Patients Admitted to the Hospital
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Oral Morphine equivalent
研究概览
简要总结
Many patients are prescribed lidocaine patches for rib fractures despite mixed evidence to their efficacy. The outcome of this trial offers significant benefit to patient care if it finds benefit of their use or if it does not. Reducing opioid use and increasing functional outcomes in geriatric patient suffering rib fractures can improve quality of life and ability to return to prior levels of function. Limiting the need for opioid prescriptions dispensed in the community, particularly to vulnerable geriatric individuals, is also a key aspect in curbing the opioid epidemic. However, even if no difference is found, it would support stopping the use of lidocaine patches in this population as a waste of money and resources. The novel approach of adding the 3rd arm to assess for placebo effect will also carry clinical value, as a placebo effect that reduces opioid use may in fact be enough to support continued use of the products given their overall low side effect risk profile compared to opioids and other pain control medications.
详细描述
Many patients are prescribed lidocaine patches for rib fractures despite mixed evidence to their efficacy. The outcome of this trial offers significant benefit to patient care if it finds benefit of their use or if it does not. Reducing opioid use and increasing functional outcomes in geriatric patient suffering rib fractures can improve quality of life and ability to return to prior levels of function. Limiting the need for opioid prescriptions dispensed in the community, particularly to vulnerable geriatric individuals, is also a key aspect in curbing the opioid epidemic. However, even if no difference is found, it would support stopping the use of lidocaine patches in this population as a waste of money and resources. The novel approach of adding the 3rd arm to assess for placebo effect will also carry clinical value, as a placebo effect that reduces opioid use may in fact be enough to support continued use of the products given their overall low side effect risk profile compared to opioids and other pain control medications
AIM 1: Determine if a 3-armed placebo controlled randomized trial evaluating the efficacy of 4% lidocaine patches is feasible on a large scale with up to 500 enrolled patients across multiple institutions.
Objective 1: Evaluate the study design, randomization system, drug delivery and placebo creation processes to determine barriers to a larger multicenter study design.
AIM 2: Determine if the use of 4% lidocaine patches decreases the utilization of opioids in geriatric (Age ≥65) patient with rib fractures and minimal other injuries by 50% or more during the first 72 hours of hospitalization.
Objective 2: Determine an appropriate target opioid reduction rate and appropriate enrollment numbers for a future a larger scale trial. We suspect a 50% opioid reduction may be larger than would be expected for a single aspect of multimodal pain control treatment. While the study will be powered to identify this difference, it is more likely that a 20-40% reduction could be achieved and therefore help determine appropriate power calculations for a future trial.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age>/= 65 years
- •Patients with injuries meeting an AIS score </=2
- •Patients admitted to trauma service
- •Patients able to consent
排除标准
- •Age <65 years
- •Unable to consent
- •Chronic pain medication usage; defined as >/= 3 weeks of >/= 30 mg oral morphine equivalent
- •History of allergic reaction to lidocaine or adhesive tape
- •Prisoners
- •Patient will be excluded if pain is worse in non-ribs location
- •Patient will be excluded if he has injuries not meeting our criteria
研究组 & 干预措施
Placebo group
干预措施: Placebo Patch (Other)
Intervention group
干预措施: 4% Lidocaine Patch (Drug)
结局指标
主要结局
Oral Morphine equivalent
时间窗: Up to 30-days. From date of randomization until the date of patient discharge
Patient reported pain score (scale from 0-10)
时间窗: Up to 30-days. From date of randomization until the date of patient discharge
Oral Morphine Equivalent
时间窗: From date of enrollment until the date of discharge, assessed up to 1 week in a typical hospital stay
Oral Morphine Equivalents Calculated based on opioids used between enrollment in the study until the time of discharge
次要结局
- 30-day opioid usage(30-day post discharge using the Wisconsin Prescription Drug Monitoring Program)
- Pain Scores(Daily median score from post enrollment until discharge)
- Post Discharge Opioid Prescription(Total from Hospital discharge until 30 days post discharge)
研究者
Jacob Peschman, MD
Assistant professor of surgery
Medical College of Wisconsin