The Effect of an Educational Pain Approach Before Elective Lower-extremity Surgery on 6-month Post-operative Use of Opioid Medication: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Opiate Prescriptions
研究概览
简要总结
The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.
详细描述
Hypothesis: The primary hypothesis is that the educational intervention provided prior to the surgery and prior to the prescription, will result in a greater understanding and awareness of the deleterious effects of long-term use of opioid based medications, and in turn reduce utilization post-operatively in the long-term (6 months).
Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after surgery in subjects that received the education compared to those that received usual care education.
Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and sleep) between groups over the 6-month period after surgery.
Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled subjects for the 12 months leading up to a surgical procedure. Identify factors that could account for differences in opioid medication utilization, and any potential interaction effect between intervention, opioid use, and clinical outcomes following surgery.
Study Procedures/Research Interventions:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any Tricare-eligible patient scheduled for a pre-operative surgery appointment for an elective orthopaedic surgery of the hip, knee, or foot/ankle at SAMMC.
- •The surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
- •Between the age of 18 - 65 years
- •Read and speak English well enough to understand the education, provide informed consent and follow study instructions (the surgeon, investigators, or research assistants will make this determination. Any patient that needs an interpreter will not be allowed to enroll).
排除标准
- •Known aversion or allergy that would prevent the patient from taking any opioid-based pain medication (any contraindications to using opioids)
- •History of prior surgery to the same location.
结局指标
主要结局
Opiate Prescriptions
时间窗: 6 months
Total opiate prescriptions
次要结局
- Numeric Pain Rating Scale(baseline, 1 month, 6 months)
- PROMIS-29(baseline, 1 month, 6 months)
研究者
Dan Rhon
Senior Scientist, Center for the Intrepid
Brooke Army Medical Center