Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Morphine equivalents used
研究概览
简要总结
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthopaedic injury requiring surgery
- •Evaluation and treatment at UCSD
- •Age 18years or older
- •Ability to understand the content of the patient information/Informed Consent Form
- •Signed and dated Institutional Review Board (IRB) approved written informed consent
排除标准
- •Polytrauma
- •Any not medically managed severe systemic disease
- •Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.
- •The patient prefers one type of pain management protocol and is not willing to be randomized.
- •Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control
- •Pregnancy or women planning to conceive within the subject participation period (1 year)
- •o Pregnancy will be self-reported and no test will be performed to test for it.
- •Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
研究组 & 干预措施
Multimodal pain post-op management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine)
干预措施: Multimodal Pain Management (Ibuprofen/Acetaminophen/GABAPentin/0.25%Bupivacaine) (Drug)
结局指标
主要结局
Morphine equivalents used
时间窗: 1 year
Morphine equivalents used over 1 year
次要结局
- Pain Score (0-10, 0=no pain, 10=most severe pain)(1 year)
- Number of Complications(1 year)
研究者
William Kent
Assistant Professor of Orthopaedic Surgery
University of California, San Diego